Executive Assistant(Legal & Compliance)

US Discovery
San Francisco Bay Area

At Zai (NSDAQ:ZLAB), we are working to generate optimum therapeutics for significant diseases affecting peoples throughout the world. Transforming lives of patients by identifying new and smarter ways to treat and cure disease is out mission. We bring together the best minds from all over the world to pursue our goals.

The Role

Zai Lab is seeking a dynamic, self-motivated, highly experienced Executive Assistant to provide comprehensive executive support to Zai’s Legal, Compliance & Sustainability c-suite and senior-level executives. And, you will act as the Office Manager for our brand new Cambridge, MA location.

This position reports to the Chief Legal Officer.

Executive Assistant:

  1. Provide administrative support for Chief Legal Officer, Chief Compliance Officer, Chief Sustainability Officer and their respective teams.
  2. Assume ownership of calendars utilizing strategic gatekeeping & prioritization. Apply thorough context & knowledge of priorities on an org and company level, with awareness of broader org, company & external events.
  3. Plan, coordinate and book complex travel. Anticipate and monitor external factors that could impact travel and proactively addresses.
  4. Complete and submit expense reports as prescribed by T&E policy in a timely manner. Facilitate expense approvals on behalf of the manager as appropriate. Actively resolve expense issues with internal and external partners. Submit and track invoices. Work with procurement teams as needed.
  5. Support meeting logistics including calendaring. May also support facilitation, meeting materials, agenda, notes/follow ups, and supplemental needs, live streaming/recording or IT support as needed.
  6. Logistical support and planning of external team events and activities (offsites, meals, milestone & quarterly team activities, seasonal celebrations).
  7. Assist with legal document preparation.
  8. Perform additional duties as assigned.


Office Manager:

  1. Manage and organize the day-to-day operations of Zai’s Cambridge. MA office, ensuring things are running efficiently
  2. Maintain a tidy and pleasant office environment. Keep the kitchen organized and stocked with snacks and pantry supplies and well organized.
  3. Welcome visitors and appropriately handle their experience. Reception management includes incoming phone calls, mail, receiving and distributing packages, when necessary, etc.



Minimum Qualifications:

  • High School/Secondary Education or Equivalent
  • 6+ years relevant experience working at a Senior or Executive level
  • Experience with Microsoft Outlook Mail & Calendar; Office 365 Applications (Excel, PPT, Word, Teams, OneDrive, OneNote, SharePoint), collaboration applications (Slack, Teams, Zoom, Sli.do, etc.)
  • Ability to work standard office hours and be onsite in the Cambridge, MA office a minimum of 4 days/week
  • Manage and organize the day-to-day operations of Zai’s Cambridge. MA office, ensuring things are running efficiently
  • Ability to independently work on complex issues
  • Demonstrates excellent written and verbal communication and operations management, specifically related to time management, budgets and projects.
  • Ability to exercise appropriate discretion in all circumstances regarding materials or information of a confidential nature, respecting Zai’s policies and procedures.
  • Strong interpersonal and relationship building skills to work with a variety of personalities and adapt to different styles.
  • Demonstrated ability to manage competing priorities, effective time management skills, pro-active approach, high attention to detail, results and solutions oriented.
  • Zai Lab requires all employees who are working onsite or who are in customer facing positions to be vaccinated against COVID-19 (subject to any legally required exemptions)


Preferred Qualifications:

  • Experience in a pharmaceutical or life-sciences industry preferred
  • Paralegal training/experience preferred
  • Notary license is a plus


If you are interested in this role, please submit your resume to talent_us@zailaboratory.com


Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.

Lead/Headof Global Corporate Communications

Communications
San Francisco Bay Area
About the company

At Zai (NSDAQ: ZLAB), we are working to generate optimum therapeutics for significant diseases affecting peoples throughout the world. Transforming lives of patients by identifying new and smarter ways to treat and cure disease is out mission. We bring together the best minds from all over the world to pursue our goals. 

 

The Role

Zai Lab is seeking a dynamic, self-motivated, highly experienced corporate communications leader to help shape our strategy and provide counsel to our leaders on a range of topics and issues in the US. The candidate will lead a new team focused on the Zai Lab brand, telling the Zai Lab story, creating opportunities for corporate visibility and leadership for the Company as it positions itself to be a leading global biopharmaceutical company. This leader will work with colleagues across the company including R&D, Investor Relations, Legal, HR and Business Development and be comfortable working across time zones and cultures. This position has one direct report with the opportunity to expand the team over time and reports to the SVP and Head, Global Communications.

 

Primary Responsibilities

This position will make a difference for patients by:

  • Leading our corporate communications strategy and planning, including the quarterly earnings reporting process, top-line business initiatives, corporate social responsibility, executive communications, business development and corporate issues.
  • Serve on the global communications leadership team, and help to shape the direction of our narrative and team.
  • Engage with business/financial media and other external stakeholders.
  • Execute reactive and proactive communications plans and strategies using appropriate digital channels and formats.
  • Liaise with Investor Relations, Legal/Compliance, R&D and Commercial teams, as appropriate, regarding announcements, issues management, and launches.
  • Collaborate to cultivate strong relationships with internal partners in Regional Communications, Finance, Investor Relations, Business Development, Legal, and HR, to help Zai Lab raise the bar in our communications.
  • Manage an effective and innovative thought leadership program and to develop strategic speaking plans for our CEO and key leaders in the US and globally.

 

Qualifications

  • 12+ years of corporate communications experience in an agency or in-house environment (with pharma/healthcare industry preferred).
  • A minimum of a BA/BS degree.
  • A passion for patients, healthcare and our mission.
  • Innovative and creative approach to storytelling, not just traditional PR tactics.
  • Excellent writing, editing and messaging skills.
  • To be flexible, empathetic, collaborative and an all-around team player.
  • A global perspective and an ability to work with different cultures, perspectives and attitudes.
  • Ability to thrive and succeed in a dynamic, fast-paced environment.
  • Effective communication skills across all levels of an organization — from individual contributors to senior leaders.
  • Proven ability to manage external resources and stay within budget.


Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

 

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

Lead,Internal Communications (Remote Position)

Communications
San Francisco Bay Area

At Zai (NSDAQ:ZLAB), we are working to generate optimum therapeutics for significant diseases affecting peoples throughout the world. Transforming lives of patients by identifying new and smarter ways to treat and cure disease is out mission. We bring together the best minds from all over the world to pursue our goals.

 

The Role

 

Zai Lab is seeking a dynamic, self-motivated, highly experienced communications leader

lead the enterprise-wide, global employee communications function. This includes charting a vision and strategy for internal communications, developing actionable plans in partnership with key functions, such as HR, and ensuring their execution, aligning resources and skill sets to communicate with Zai Lab’s growing global organization. This leader is responsible for creating strategies to engage with leaders and people managers and has deep expertise in change management. This role will partner with IT to conceive and launch the Company’s intranet site. This position reports to the SVP, Global Communications.

 

Primary Responsibilities

  • Connect, inform, and inspire employees at every level to the company’s mission, strategic priorities and values
  • Develop innovative ways of engaging our employees through content, internal events, and technologies such as the intranet. Help us become “mobile first.”
  • Advise senior leaders at Zai Lab at high-impact communications moments and help create events and written communications
  • Set the strategy, vision and plans for companywide, global employee communications function, aligning resources and skill sets in support of plans. Deliver excellence, on time and on budget.
  • Partner closely with the Comms, Investor Relations and HR teams on company-wide communications, such as company milestones, financial results, product announcements, and company-wide initiatives
  • Partner with the Content & Channels team to oversee the Company intranet site and create strategies for internal digital engagement.
  • Leads/advises change management initiatives where necessary.
  • Anticipates and plan for the long-term success of the function.

 

 

Qualifications

  • A BA or equivalent degree, preferably in healthcare communications, journalism, or related area
  • 10+ years of experience in internal communications, including 3+ years leading a team and 3+ years in a global environment. Public company experience a plus!
  • A team mentality. Zai Lab is a team-oriented company that requires effective collaboration to drive results. You are someone who not only likes working in a team, but enjoys leading one, too.
  • Personality in your writing (and you’re not afraid to show it)
  • Strong planning skills. You know how to manage complex projects, multiple stakeholders and competing priorities to create an actionable plan and get the most impactful work done. You build the feedback loops that will make your plan a success: determining and informing the right stakeholders in Communications and beyond, gaining their buy-in and keeping them informed
  • Poise. You know what questions to ask to get to the heart of the matter and aren’t afraid to ask them
  • A start-up mentality, a sound strategic thinker with excellent judgment and lots of energy. This is a lean team so get ready to roll up your sleeves. Sometimes you’ll be the visionary, sometimes you’ll provide the first draft.,
  • Very strong writing and editing skills.

 

If you are interested in this position, please send an email with your resume to talent_us@zailaboratory.com


Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

 

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.

Associate Medical Director- Oncology

US Discovery
San Francisco Bay Area

At Zai (NSDAQ:ZLAB), we are working to generate optimum therapeutics for significant diseases affecting peoples throughout the world. Transforming lives of patients by identifying new and smarter ways to treat and cure disease is out mission. We bring together the best minds from all over the world to pursue our goals.

The Role

We are seeking an experienced clinical development leader to support the growth of our global development efforts within oncology. The Associate Medical Director reports to the Executive Director, Clinical Development and provides clinical and drug development expertise for early-stage drug development assets primarily focused on DNA damage response (DDR) and immuno-oncology. The position will support more than one asset in the early phases of drug development. This opportunity will actively provide scientific leadership to a cross functional clinical team guiding strategic design, execution, and interpretation of key clinical studies. They will assume visibility both within the Zai organization as well as externally through interactions with partners to monitor study participants, maintain study conduct and protocol compliance. This newly created position has evolved due to the growth of the pipeline and the ongoing support needed to expand the US based global footprint.


Responsibilities

  • Provide key medical expertise and input in supporting the development and management of early stage pipeline assets, immuno-oncology preferred
  • Provide strategic and tactical direction to project teams
  • Assist in preparation of protocol writing
  • Interpret data, assess the integrity of trial data, and provide scientific summaries
  • Provide support for the regulatory documentation and submission for the clinical program
  • Ensure operational execution of the clinical trials
  • Work within a matric team organization to drive and deliver timely completion of all clinical activities
  • Engage with key external partners, including site investigators
  • Integrate relevant scientific findings from the trials and the literature to facilitate research


Your Background

The successful candidate we hire will be a sophisticated leader who has the right degree of drive and independence with a track record in oncology/immuno-oncology clinical development. S/he will have the following mix of personal and professional characteristics:


  • MD/ PhD/ PharmD/ or Secondary Scientific Degree with Immuno-Oncology experience
  • A minimum of 2 years in the pharmaceutical industry and/or a strong academic clinical trial experience
  • Strong scientific knowledge of basic research in its application to the drug development process
  • Demonstrated ability to effectively work and collaborate within a matrix team organization
  • Demonstrated expertise in drug trial design, scientific writing, and successful implementation of clinical protocols and clinical study reports
  • Experience in reviewing & interpreting study data/reports and presenting findings to the project team
  • Support building and maintaining effective relationships with external partners
  • Excellent organizational, written, and oral communication skills
  • Ability to adapt to a changing work environment with proven agility in prioritizing and navigating competing demands
  • Exhibits integrity, honesty, and sense of accountability


If you are interested in this role, please submit your resume to talent_us@zailaboratory.com


Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.

HR TotalRewards Leader

HR
San Francisco Bay Area

Based in Menlo Park, CA since 2018, Zai Lab U.S. is focused on discovering and developing novel therapies for the treatment of cancer and inflammatory diseases. We are an innovative, research-based, commercial stage company, with over 850 employees worldwide and a diversified and strong pipeline poised for continued growth. This is an exciting time for us as we build our R&D Drug Discovery team and advance our global pipeline, aiming to produce 1-2 global INDs per year. 


At Zai (NSDAQ:ZLAB), we are working to generate optimum therapeutics for significant diseases affecting peoples throughout the world. Transforming lives of patients by identifying new and smarter ways to treat and cure disease is out mission. We bring together the best minds from all over the world to pursue our goals.


POSITION SUMMARY:

The HR Total Rewards Leader is responsible for the execution and implementation of Zai Lab US’s total rewards strategies to attract, engage and retain Zai Lab US’s workforce nationwide. This individual will be responsible for developing programs and policies to align with the corporate business strategy maintaining and/or enhancing competitive market position. In addition, this position is responsible for leading the development of a sustainable and scalable employee data infrastructure through the deployment and use of the company’s HR Information Systems, including web-based and mobile tools for managers and employees, and the management of accurate employee-related data. This role will partner extensively with Zai Lab Headquarters HR Team located in Shanghai, China.


ESSENTIAL DUTIES AND RESPONSIBILITIES: 

  • Provide leadership and direction around compensation and benefit programs to ensure competitiveness; recommend and participate in relevant surveys, prepare competitive benchmarking analysis, and perform annual incumbent analysis.
  • Manage and administer all compensation activities including, but not limited to new hire, transfer and promotion offer, annual compensation review process, corporate incentive plan.
  • Manage and administer all health & welfare plans, retirement plans, and wellness program, including annual renewal process.
  • Design a robust evaluation methodology for job evaluation and levelling; ensure accurate job descriptions are available for all positions and partnering with managers to appropriately identify GxP positions.
  • Execute strategies to ensure effectiveness of recognition programs, including program promotion, interpretation, and usage.
  • Collaborate with HR team and line management to provide sound judgment and counsel on compensation, benefits, and leave of absence issues and practices for the US.
  • Design, coordinate and implement annual and on-going employee communications and programs to ensure employees continually understand and value their total rewards package.
  • Lead and execute on US based HR systems projects to ensure efficient processes and to minimize redundancy in workload while facilitating a self-service work environment (ex: performance management, surveys, and applicant tracking system).
  • Support Head of HR, US, and collaborate cross-functionally with Legal and Finance to ensure proper management of the Compensation Committee governance process for the US.
  • Responsible for leave administration; further develop and ensure all leave related documentation and communication strictly adhere to federal and state (FMLA, CFRA, PDL, ADA, etc.) laws and regulations.
  • Design and develop quarterly workforce analytics reports for HR and Senior Leadership Team.
  • Conduct new hire orientation and exit interviews.
  • Ensure compliance across various labor and employment areas including but not limited to EEO, AAP, FLSA, ERISA, ACA, HIPAA, federal and state statutes, etc. As required, lead employment related audits such as IRS, OFCCP.
  • Maintain an up-to-date knowledge of legislation as well as market trends impacting compensation and benefits programs and best practices and be proactive in amending policies and programs.
  • Manage focus area with emphasis on maintaining and driving effective internal controls (SOX 404 Compliance) and documenting policies and procedures.


KNOWLEDGE AND SKILL REQUIREMENTS

  • BA/BS or HR certification with 10 plus years relevant experience in compensation, benefits, HRIS and general HR practices; equivalent combination of degree and less experience may be considered
  • Degree or concentration in Human Resources preferred
  • Demonstrated ability to evaluate, design and implement total rewards programs based on market assessment and business strategy
  • Experience w/ PEOs (Trinet)
  • Proven strong leadership skills including the ability to influence across all levels and functions of an organization
  • Excellent interpersonal and communication skills including ability to tailor communications to match the level of the audience
  • Strong collaboration and customer service skills
  • Excellent project management skills
  • Highly effective decision-making and judgment
  • Extensive knowledge of Federal and California Labor Laws and practices
  • Flexibility, adaptability and ability to function in a fast paced, changing environment
  • Experienced in HR databases
  • Experienced in Microsoft Office Suite with emphasis in Excel

 

WORKING CONDITIONS


PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus. 


WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Occasional travel may be required.


Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

 

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

Clinical SupplyManager

US Discovery
San Francisco Bay Area

Based in Menlo Park, CA since 2018, Zai Lab U.S. is focused on discovering and developing novel therapies for the treatment of cancer and inflammatory diseases. We are an innovative, research-based, commercial stage company, with over 1,600 employees worldwide and a diversified and strong pipeline poised for continued growth. This is an exciting time for us as we build our R&D Drug Discovery team and advance our global pipeline, aiming to produce 1-2 global INDs per year.


At Zai (NSDAQ: ZLAB), we are working to generate optimum therapeutics for significant diseases affecting peoples throughout the world. Transforming lives of patients by identifying new and smarter ways to treat and cure disease is our mission. We bring together the best minds from all over the world to pursue our goals.


Primary Function:

The candidate we are looking for is a a dynamic, highly motivated, experienced individual for the position of Clinical Supply Chain Manager reports to the Associate Director of Clinical Supply Chain. The preferred location of the position is in Palo Alto, CA but flexibility is possible for the right candidate.


Responsibilities:

  • Works with clinical supply team in China to support trials/joint global trials in US and elsewhere from supply perspectives; supports importation/exportation of DP.
  • Responsible for scheduling and delivery of clinical supply including strategies for creating label and packaging design, randomization, packaging, labelling and distribution of clinical supplies.
  • Plans, establishes, manages and monitors activities related to clinical supplies at the program and study level, in cooperation with internal and external.
  • Drives the drug supply material planning for clinical studies using investigational product, and comparator material in collaboration with the project teams.
  • Ensures timely and quality delivery of clinical supplies that meets study protocol, regulatory, and budgetary requirements. Ensures that key project milestones are met; negotiates and communicates supply plan timelines to internal and external customers and partners.
  • Develops and manages the forecasting and ordering investigational product. Ensures forecasts/demands are complete and in place for studies at a program level.
  • Collaborates with Clinical Operations to identify demand assumptions, such as enrollment rate, number of sites, etc. Collaborates with Clinical Trail Managers to develop the drug distribution strategy for each trial and leads the development, review and acceptance testing of IVRS when necessary.
  • Leverages CRO capabilities in clinical supply of investigational product. Works with Quality Assurance to select and qualify global/local vendors. Cooperates with and monitor CRO as appropriate.
  • Creates clinical supply study budgets, and responsible for amending budgets.
  • Other duties and activities as defined by management to enhance management of clinical trial inventory.


Requirements:

  • Bachelor’s degree in an applicable discipline, such as pharmaceutics, medicine, etc.
  • 5+ years progressive experience in Clinical Supply Chain preferably within the biotech, biopharma, pharmaceutical, CRO, and industry in US or EU.
  • Good knowledge of clinical supply import/export regulation/policy, GMP, logistic, project management, IRT systems, medication management and use of advanced simulation tools.
  • Understanding and working knowledge of the overall drug development and clinical development process in enterprise, including a knowledge of clinical protocol design, and an in-depth knowledge of clinical labeling and packaging procedures and the investigational material supply chain.
  • Strong working knowledge of standard business software, including MS Excel, Word, and PowerPoint.
  • Strong analytical and organizational skills.
  • Ability to work both independently, and in a team environment.
  • Ability to communicate effectively both orally and in writing with external vendors and partners.
  • Good Mandarin in oral and written preferred.


Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.



All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.

Clinical TrialManager

US Discovery
San Francisco Bay Area


Based in Menlo Park, CA since 2018, Zai Lab U.S. is focused on discovering and developing novel therapies for the treatment of cancer and inflammatory diseases. We are an innovative, research-based, commercial stage company, with over 850 employees worldwide and a diversified and strong pipeline poised for continued growth. This is an exciting time for us as we build our R&D Drug Discovery team and advance our global pipeline, aiming to produce 1-2 global INDs per year.

 

 

At Zai (NSDAQ: ZLAB), we are working to generate optimum therapeutics for significant diseases affecting peoples throughout the world. Transforming lives of patients by identifying new and smarter ways to treat and cure disease is out mission. We bring together the best minds from all over the world to pursue our goals.

 

 

Primary Function:

 

The Clinical Trial Manager/Senior Clinical Trial Manager will lead, manage and co-ordinate the operational strategy, risk management, and overall execution of clinical trials from study start-up to close out at a global level in accordance with ICH-GCP and applicable local regulations. Collaborate with cross functional stakeholders to ensure deliverables are met in terms of quality, compliance, budget, and timing. This role may work collaboratively on one trial or across several trials to support clinical operations activities.

 

 

 

Major Responsibilities and Duties:

 

Lead and coordinate a cross-functional study team to ensure the clinical trial progresses as planned.

Accountable for the overall operational delivery (e.g. country and site selection/start-up, site contracts, patient recruitment and retention, etc) of assigned clinical trials; ensuring that study-level deliverables are met according to timeline, budget, and quality requirements.

Participates in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central/specialty lab, ECG, imaging, PRO specifications, drug supply, biomarker/sample management plans, TMF, and CSRs.

Drafts and implements study plans including; vendor oversight, risk, quality, safety, communication, trial monitoring, and TMF.

Ensures TMF creation and QC completion.

Supports EDC, IxRS, and CTMS systems and data maintenance.

Tracks budget, timelines, milestones, and critical study activities, identifies issues and proposes potential resolutions.

Provides input to the study budget and manages assigned vendor budget(s); communicates variances in actual versus forecasted spend in vendor budgets and presents an action plan for resolution.

Participates in the selection of vendors (participates in the Request for Proposal (RFP) process) on a global scale.

Oversees delegated outsourced activities to ensure CRO and vendor delivery against the contracted scope of work.

Leads the Investigator Meeting preparation and execution with the support from cross-functional team members.

Stays current on relevant therapeutic area knowledge and clinical research best practices.

Ensures study adherence to ICH/GCP and company SOPs.

 

 

Qualifications:

 

Undergraduate degree in a scientific or health-related discipline.

Minimum of 5 years relevant clinical experience in the pharmaceutical industry, including 2 years in study management experience, or equivalent combination of education, training, and experience.

Demonstrated ability in clinical study management processes and clinical/drug development.

Highly effective verbal and written communication skills; effectively deliver key messages; aptitude to independently communicate with teams and stakeholders.

Experience with effective vendor management.

Strong customer focus with investigators, functional peers, vendors, etc.

Excellent planning and organizational skills.

Ability to build trusting and collaborative relationships globally.

Working knowledge of international regulatory and ICH Good Clinical Practice guidelines.

Willingness to travel domestically and internationally and work across cultures.

 

Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

 

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.

Clinical TrialAssistant

US Discovery
San Francisco Bay Area

Based in Menlo Park, CA since 2018, Zai Lab U.S. is focused on discovering and developing novel therapies for the treatment of cancer and inflammatory diseases. We are an innovative, research-based, commercial stage company, with over 850 employees worldwide and a diversified and strong pipeline poised for continued growth. This is an exciting time for us as we build our R&D Drug Discovery team and advance our global pipeline, aiming to produce 1-2 global INDs per year.


At Zai (NSDAQ:ZLAB), we are working to generate optimum therapeutics for significant diseases affecting peoples throughout the world. Transforming lives of patients by identifying new and smarter ways to treat and cure disease is out mission. We bring together the best minds from all over the world to pursue our goals.


Primary Function:

The Clinical Trial Assistant (CTA) is a member of the clinical trial team supporting delivery of clinical studies within Zai Lab. The CTA will support the study team to ensure the operational deliveries are executed within the expected timeline, approved budget, and at high quality from protocol development through study set-up, maintenance, close-out, and study archiving.


The CTA supports the study team in delegated activities and provides technical, administrative, and logistical support to ensure efficient execution of clinical trials, in line with ICH/GCP, Zai Lab SOPs, and regulatory regulations.

Major Responsibilities and Duties:

  • Lead the set-up of the electronic Trial Master File (eTMF) system and Clinical Trial Management System (CTMS). Ensure information is updated during the course of the study per ICH/GCP and Zai Lab SOPs.
  • Create and maintain communication platforms (i.e. MS Teams, SPOL, group email list) for the study team.
  • Control systems access for assigned study(ies), including but not limited to IxRS, EDC, CTMS, and eTMF.
  • Support clinical trial registration and disclosure on public websites per applicable regulatory requirements.
  • Responsible for overall TMF status. Guide study team members on the eTMF/paper TMF document transfer and archival. Lead the quality check (QC) per the TMF plan.
  • Facilitate finance related activities such as contract sign-ff, IO and PO set-up, processing invoices, and budget tracker maintenance and reconciliation for sites and third-party vendors.
  • Coordination and tracking of clinical supplies.
  • Coordinate and arrange internal and external meetings, including but not limited to study team meetings, vendor defense meetings, Investigator Meetings, and committee review meetings. Take meeting minutes, as needed.
  • Compile and maintain the clinical trial related lists and logs, including but not limited to study document version tracker, decision/issue/risk log, study contact list, Q&A log, vendor list, and study specific training log.
  • Draft and distribute newsletters/communications/presentation materials to internal and external stakeholders.
  • Complete delegated tasks during audit and inspection by regulatory authorities.
  • Expected to work on tasks assigned in less complicated clinical trials independently.


Qualifications:

  • Bachelor’s degree or above (Life Sciences preferred) or certification in a related health profession (i.e. nursing, medical or laboratory technology) from an accredited institution.
  • AA degree (or below) with 5+ years related professional experience is also acceptable.
  • Proven organizational and presentation skills.
  • Ability to manage multiple tasks meticulous attention to detail.
  • Quick learner and a team player.
  • Excellent written and verbal communication skills.
  • Computer proficiency in Microsoft Word, Excel, PowerPoint and Outlook.
  • Good knowledge of ICH/GCP.
  • One year experience as a CTA, CRC, or other role in clinical trials is preferable.


Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.

Principal Scientist,DMPK

US Discovery
San Francisco Bay Area

Based in Menlo Park, CA since 2018, Zai Lab U.S. is focused on discovering and developing novel therapies for the treatment of cancer and inflammatory diseases. We are an innovative, research-based, commercial stage company, with over 1,600 employees worldwide and a diversified and strong pipeline poised for continued growth. This is an exciting time for us as we build our R&D Drug Discovery team and advance our global pipeline, aiming to produce 1-2 global INDs per year. 

 

At Zai (NSDAQ:ZLAB), we are working to generate optimum therapeutics for significant diseases affecting peoples throughout the world. Transforming lives of patients by identifying new and smarter ways to treat and cure disease is our mission. We bring together the best minds from all over the world to pursue our goals.

 

We are seeking a highly skilled and motivated Principal Scientist with expertise in Bioanalysis and Pharmacokinetics to join Zai Lab (US)’s Discovery and Preclinical team.

 

Responsibilities:

  • The successful candidate will involve in some or all of the following activities.
  • Devise and carry out bioanalytical (BA) strategies for the quantification of large molecule drug candidates and anti-drug antibodies in biological matrices
  • Coordinate in vivo pharmacokinetic studies in preclinical species
  • Analyze pharmacokinetic data as well as pharmacokinetic/pharmacodynamic (PK/PD) data to support discovery/preclinical development projects
  • Participate and contribute to discovery/preclinical development project teams
  • Write documents for regulatory filings
  • Be self-driven, highly organized, focused and enjoy working in a dynamic team environment

 

Requirements:

  • PhD degree with at least 6 years of experience in an industry setting
  • Devise bioanalytical strategies for large molecule therapeutic candidates
  • Expertise and experience in PK/PD analysis using Phoenix and other data analysis software, design, interpretation, simulation, and reporting to provide guidance for drug discovery and preclinical development projects
  • Hands-on experience with LC-MS/MS
  • Excellent problem-solving and strong communication, data presentation, and written skills
  • A strong fit with Zai Lab (US)’s culture and core values of commitment to excellence, patient-centered and collaboration. Resourceful, self-driven and enthusiastic with the ability to thrive in a dynamic start-up environment

 

If you are interested in this position, please send an email with your resume to talent_us@zailaboratory.com

Senior ScientistIn Vivo Pharmacology

US Discovery
San Francisco Bay Area
Based in Menlo Park, CA since 2018, Zai Lab U.S. is focused on discovering and developing novel therapies for the treatment of cancer and inflammatory diseases. We are an innovative, research-based, commercial stage company, with over 1,600 employees worldwide and a diversified and strong pipeline poised for continued growth. This is an exciting time for us as we build our R&D Drug Discovery team and advance our global pipeline, aiming to produce 1-2 global INDs per year. 

 

At Zai (NSDAQ: ZLAB), we are working to generate optimum therapeutics for significant diseases affecting peoples throughout the world. Transforming lives of patients by identifying new and smarter ways to treat and cure disease is our mission. We bring together the best minds from all over the world to pursue our goals. 


Primary Function:

As part of the In Vivo Pharmacology team in Menlo Park, the successful candidate will be responsible for developing, planning, and performing animal studies using human and mouse cell lines and performing ex vivo analyses to support discovery and development of new therapeutics in oncology and immuno-oncology.


Major Responsibilities and Duties:

  • Design in vivo studies to support the goals of oncology and/or immune-oncology projects. Includes in-house and out-sourced in vivo studies in mice.
  • Perform xenograft and syngeneic tumor studies to test efficacy, pharmacology, and mechanism of action of anticancer therapeutics. Hands-on work will include developing and optimizing xenograft and syngeneic tumor models, intravenous, intraperitoneal, and intragastric dosing of mice, and isolation and processing of mouse blood and tissue.
  • Support the development of new in vivo models. May include, but is not limited to, humanized mouse models, the use of bioluminescent imaging, and in vivo models of target discovery
  • Ability to perform in vitro and ex vivo work to examine drug pharmacodynamics and mechanisms of action, including: 1) Multi-color flow cytometry to examine tumor infiltrating immune cells. 2) Assays to examine target binding and downstream pathway modulation, including phosphoprotein and cytokine analyses. 3) Cell-based assays, including viability, cytotoxicity, and proliferation of cancer cells and activation and cytotoxicity of immune cells
  • Analyze and present data as a key member of project teams representing the In Vivo Pharmacology department.
  • Work collaboratively with other departments on multiple projects concurrently and coordinate activities across functions.


Qualifications:

  1. PhD with at least 3-5 years of post-doctorate experience or MS with 8-10 years of experience.
  2. At least 3-5 years of hands-on in vivo experience designing and running in vivo models of oncology and/or immuno-oncology is required.
  3. Expertise in handling and dosing mice, including intravenous, intraperitoneal, and intragastric administration, and mouse tissue and blood collection is essential.
  4. Experience with animal models of auto-immunity and/or inflammation is a plus.
  5. Hands-on experience with various in vitro laboratory techniques, including multi-color flow cytometry, Western blot, qRT-PCR, ELISA, and immunohistochemistry is strongly preferred.
  6. Capable of working independently in a fast-paced, team-oriented environment, demonstrating multitasking capabilities.
  7. Excellent experimental design, troubleshooting, and data analysis skills are required.
  8. Great communication skills and team spirit is a must; ability to communicate results within Pharmacology and Biology teams and at project team meetings required.
  9. Previous industry experience is a preferred.


Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

 

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.

Senior Scientist,DDR, Translational Medicine

US Discovery
San Francisco Bay Area

Based in Menlo Park, CA since 2018, Zai Lab U.S. is focused on discovering and developing novel therapies for the treatment of cancer and inflammatory diseases. We are an innovative, research-based, commercial stage company, with over 1,600 employees worldwide and a diversified and strong pipeline poised for continued growth. This is an exciting time for us as we build our R&D Drug Discovery team and advance our global pipeline, aiming to produce 1-2 global INDs per year.


At Zai (NSDAQ: ZLAB), we are working to generate optimum therapeutics for significant diseases affecting peoples throughout the world. Transforming lives of patients by identifying new and smarter ways to treat and cure disease is our mission. We bring together the best minds from all over the world to pursue our goals.


Primary Function:

Senior Scientist will join our Translational Medicine, DNA damage response (DDR) group and contribute to building pre-clinical translational hypotheses to guide patient selection and drug combinations with our DDR clinical pipelines, including cell cycle inhibitors or DDR inhibitors.


Major Responsibilities and Duties:

  • Contribute to positioning our cancer therapeutics in right patient selection based on pre-clinical translational hypotheses.
  • Support development of pre-clinical models and biomarker discovery to establish best patient selection strategy for our clinical trials.
  • Support Translational Medicine efforts for the DDR-targeting pipelines and Zai’s clinical assets.
  • Perform laboratory bench work with minimal supervision and present the results/findings internally and externally.
  • Perform routine assays (luminescence/fluorescence assay, qPCR, ELISA, cytotoxicity assay, western blot, immune staining, confocal microscope, gene knockdown/knockout, flow cytometer, cell culture, transfection, gene delivery with lenti/retro virus).
  • Maintain/update sample/cell database.
  • Analyze data from experiments and present the data at a meeting.


Qualifications:

  • PhD with a minimum of 3-5 years' relevant post-graduate experience in oncology, or MS with a minimum of 8 years' industry experience in oncology.
  • Broad training/experience in Molecular/Cell Biology including but not limited to cell culture, DNA/RNA extraction, PCR/qPCR, ELISA, western blot, microscope, and primary cell isolation/culture is required.
  • Experience in analysis for signaling pathway in tumor cell lines is required.
  • Proficiency in cell cycle analysis using flow cytometer is required.
  • Knowledge of tumor microenvironment, immune-oncology, human immunology, in vivo animal model, biomarker, RNAseq, histology, immunohistochemistry is huge plus.
  • Strong communication and collaboration skills, and capability to conduct research in fast-paced, cross-functional team environment.
  • Ability to interpret data clearly and concisely both verbally and visually in presentations.
  • High integrity and desire to discover and develop transformational medicines for patients.



Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.


All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.

Scientist II,Precision Medicine/Synthetic Lethality

US Discovery
San Francisco Bay Area

Based in Menlo Park, CA since 2018, Zai Lab U.S. is focused on discovering and developing novel therapies for the treatment of cancer and inflammatory diseases. We are an innovative, research-based, commercial stage company, with over 1,600 employees worldwide and a diversified and strong pipeline poised for continued growth. This is an exciting time for us as we build our R&D Drug Discovery team and advance our global pipeline, aiming to produce 1-2 global INDs per year.


At Zai (NSDAQ: ZLAB), we are working to generate optimum therapeutics for significant diseases affecting peoples throughout the world. Transforming lives of patients by identifying new and smarter ways to treat and cure disease is our mission. We bring together the best minds from all over the world to pursue our goals.


Primary Function:

The successful candidate will be part of an exciting Biology team focusing on the identification, validation, and advancement of novel therapeutic candidates that are designed to target cancer cells with a precision medicine/synthetic lethal approach. The candidate will perform hands-on experiments in vitro and ex vivo to examine target expression, elucidate mechanisms of action, and determine efficacy of our developing therapeutics in this exciting space.


Major Responsibilities and Duties:

  • Design and support molecular biology experiments to interrogate and identify new drug targets and preclinical development of existing targets in our synthetic lethality pipeline.
  • Hands-on work will include mammalian cell culture, drug/compound screening, and performing various molecular biology-based assays, including CRISPR-based cell line generation, flow cytometry, Western blotting, qRT-PCR, Immunofluorescence, and ELISA.
  • Perform experiments using various in vitro and ex vivo model systems/assays to elucidate molecular and phenotypic effects of target modulation.
  • Drive new target discovery efforts by performing and managing genetic (for ex. CRISPR) screens both in-house and with CROs.
  • Analyze and present experimental findings to the department and project teams.
  • Work collaboratively on multiple projects concurrently and contribute to activities across functions.


Qualifications:

  • PhD or Master’s degree in Biological Sciences/Pharmacology/Oncology.
  • 1-3 years (PhD) or 8-10 years (M.Sc) of hands-on in vitro experience in cancer biology.
  • Thorough experience in cancer cell/tissue culture and high-throughput assay development experience are required.
  • Hands-on experience with various in vitro laboratory techniques is required, including Western blotting, qRT-PCR, immunofluorescence, RNAi/CRISPR, and flow cytometry. Strong preference for candidates with CRISPR screening experience.
  • Capable of working independently in a fast-paced, team-oriented environment, demonstrating solid organizational skills.
  • Confidence in troubleshooting assays and performing and learning new data analysis skills are required.
  • Great communication skills and team spirit is a must; ability to communicate results with colleagues and with the biology team at meetings is required.


Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.



All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.

Scientist IIImmune-oncology

US Discovery
San Francisco Bay Area
Based in Menlo Park, CA since 2018, Zai Lab U.S. is focused on discovering and developing novel therapies for the treatment of cancer and inflammatory diseases. We are an innovative, research-based, commercial stage company, with over 1,600 employees worldwide and a diversified and strong pipeline poised for continued growth. This is an exciting time for us as we build our R&D Drug Discovery team and advance our global pipeline, aiming to produce 1-2 global INDs per year. NASDAQ: ZLAB


The successful candidate will be part of a Biology team focusing on the identification, validation, and advancement of novel therapeutic candidates that are designed to modulate the immune system to target cancer cells. The candidate will perform hands-on experiments in vitro and ex vivo to examine target expression, mechanism of action, and potency of our emerging immuno-oncology therapeutics.


This position is located in Menlo Park, CA


Responsibilities:

  • Provide experimental support and biology expertise for discovery and validation of new drug targets and preclinical development for existing projects in the immuno-oncology space.
  • Implement in-vitro immunologic assays for evaluating activity and mechanism of action of immune oncology drug candidates using cell lines, primary cell cultures and patient samples.
  • Develop and perform routine in vitro assays for advancing drug candidates in immune oncology field (ADCC assay, ADCP assay, CDC assay, multicolor flow cytometry, luminescence/fluorescence assay, qPCR, ELISA, cytotoxicity assay, western blot, immune staining, gene knockdown/knockout, gene delivery with lenti/retro virus).
  • Develop and perform high-throughput cell-based screening assays for I/O target screening and drug candidate screening.
  • Support ex vivo analysis to examine drug pharmacodynamics and biomarker discovery.
  • Perform laboratory bench work with minimal supervision and present the results/findings internally and externally.
  • Analyze and present data as well as rationale and design of in vitro studies to the department and project teams.
  • Work collaboratively on multiple projects concurrently and coordinate activities across functions.



Qualifications:

  1. Broad training/experience in cell biology, cancer biology, immunology, molecular biology or a related field.
  2. PhD or Master’s degree with at least 0-2 years (post-PhD) or 8-10 years (post-M.Sc) of hands-on in vitro experience in immunology/cancer biology/immune-oncology.
  3. Demonstrated success in designing, conducting, and analyzing data with minimal supervision, as evidenced by a robust track record of productivity with publications in top-tier journals.
  4. Experience with laboratory techniques to interrogate immune cell function: may include flow cytometry, cell-based assays, CRISPR and gene editing, Luminex, MSD, IncuCyte-based assays, etc…
  5. Strong communication and collaboration skills, and capability to conduct research in fast-paced, cross-functional team environment; ability to communicate results within pharmacology team and at project team meetings required.
  6. Excellent troubleshooting and data analysis skills are required.


Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

 

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.

Biosample OperationsManager

US Discovery
San Francisco Bay Area
Primary Function:

The Biosample Operations Manager (BOM) will act as the SME for all biological samples collected during a clinical trial. We are seeking an experienced BOM to support translational and biomarker activities for Zai's rapidly growing pipeline of small and large molecules in early-through late-stage clinical development. You will be accountable for the execution of the biomarker strategy that includes the planning and coordination of all operational activities required for the collection and delivery of clinical trial samples (Biomarker/CDx, PK, PD, ADA) for assigned studies. The BOM works closely with the Study Team Lead, CRO partners, Site Monitors, Clinical  Pharmacology, Translational Medicine, etc. to ensure the study protocol and overall program deliverables are met.

Major Responsibilities and Duties:

- Drives the implementation and execution of the clinical biomarker and diagnostic plans for clinical programs in early and late-stage clinical development across therapeutic areas.

- Accountable for planning, organizing, and overseeing the collection and shipping of biosamples from Investigator sites or Central Labs and their subsequent delivery to assay laboratories to ensure timely delivery and optimal analyzable quality. The BOM will also oversee the assay laboratory, ensure delivery of assay results, and is the primary contact for the assay lab.

- Manage key vendors and CROs to support clinical sample collection, assay laboratory services, sample storage, and/or biomarker analysis including drafting and reviewing RFPs, vendor selection, defining scopes of work, vendor management, and contract management in support of study objectives and goals.

- Determine timelines and resource needs for all biosample operational activities, ensure these are included in study plans, and are appropriately tracked.

- Write the Study Sample Management Plan to document cross-functional agreements on the lifecycle and reconciliation plan for each sample type.

- Accountable for ensuring that data received is consistent with the collection and assay plans and protocol.

- Provide input to clinical study protocol and ICF to review for collection and analysis rationale, the feasibility of biological sampling, and alignment with Zai Lab policies and study/program plans.

- Utilize operational and project management skills to think through issues to ensure deliverables are met; raise issues to study team lead, translational medicine scientist as needed.

- Maintain oversight of all study biosample operational activities and regularly report on status (including reconciling against consent).

- In coordination with Clinical Operations, provide education and training for sample collection, handling, and shipment, which may include optimization of laboratory manuals, contributing to the development of patient and site-friendly sample collection materials, presenting sample collection requirements at Investigator Meetings, or training of sites on collection procedures.

- Monitor effectiveness of Investigator site sample handling training and quality of samples received and recommend corrective actions as necessary.

- Ensure study adherence to ICH/GCP and SOPs.

- Identifies areas of best practice and process improvements. 

Qualifications:

- Life Sciences degree (higher qualification e.g. MSc or Ph.D. preferred).

- 4+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment.

- Competent in the application of standard business procedures (standard operating procedures (SOPs), International Conference on Harmonization (ICH),  Global Regulations, Ethics, and Compliance).

- Extensive clinical development experience of working in teams running clinical studies, particularly in oncology and/or immuno-oncology early drug development.  Successful track record in oncology employing tissue (e.g., IHC, ISH) as well as genomic biomarker endpoints from tissue and blood samples, including NGS, PBMC-based analysis, FACS, and plasma biomarker analyses.

- Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples.

- Critical reasoning skills including the identification and resolution of complex problems.

- Detailed-oriented with the ability to work independently and manage competing priorities.

- Excellent planning, organizational, and time management skills.

- Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.

- Effective communication and presentation skills.

- Proven ability to build and maintain effective working relationships.

If you are interested in this position, please send an email with your resume to talent_us@zailaboratory.com


Research Associate/ Senior Research Associate

US Discovery
San Francisco Bay Area

Primary Function:

The successful candidate will be part of an in vivo pharmacology team focusing on the validation and advancement of novel cancer therapeutic candidates. The candidate will perform hands-on experiments on rodents to examine the efficacy and mechanism of action of our anticancer therapeutics.

Major Responsibilities and Duties:

Perform in vivo studies to test oncology and immune-oncology therapeutics. Hands-on work will include cell culture, generating xenograft tumor models, intravenous (IV), intraperitoneal (IP), and intragastric (PO) dosing of mice, as well as isolation of mouse blood (via various routes) and tissues. Support ex vivo analysis to examine drug pharmacodynamics and biomarker discovery. Analyze and present data as well as rationale and design of in vivo studies to the department and project teams. Work collaboratively on multiple projects concurrently and coordinate activities across functions.    

Qualifications:

1)   Bachelor's or Master's degree in Biology/Oncology.

2)   At least 1-5 years of hands-on in vivo experience with mice, including generating and measuring xenograft  tumors, dosing via intravenous, intraperitoneal, and intragastric administration,  and collection of mouse tissue and blood is required.

3)   Basic cell culture experience is required.

4)   Hands-on experience with various in vitro  laboratory techniques will be a plus, including Western blot, qRT-PCR, ELISA,  immunohistochemistry, and flow cytometry.

5)   Capable of working independently in a fast-paced,  team-oriented environment, demonstrating multitasking capabilities.

6)   Excellent troubleshooting and data analysis skills are required.

7)   Great communication skills and team spirit is a must; ability to communicate results within pharmacology team and at project team meetings required.

8)   Previous industry experience is a plus.

If you are interested in this position, please send an email with your resume to talent_us@zailaboratory.com

(Associate)Brand Communication Manager (new product)

Communications
Shanghai

Job Description:

1. Develop communication strategy & plan for each brand which is aligned with business goals.

2. Manage the program/activities and responsible for the good results in align with the plan.

3. Work independently to supervise agency to develop executional plan including budgets for assigned projects.

4. Supports manager to conduct issues management for each brand and provides proactive, strategic external affairs recommendations and issues management counsel and recommendations to relevant Commercial Leadership Teams.

Qualifications:

1. Bachelor degree and above (major in journalism, English, communication or media field is preferred).

2. Good writing skills in Chinese for release, editorial story development.

3. Good language skills for oral and written English.

4. Good interaction and influencing skills with various stakeholders including internal (marketing, medical, commercial and global colleagues) and external (media, KOLs and industry associations).

5. At least 5 years work experience in product communication or marketing in MNCs, PR agency or related fields preferred.

6. Solid and hands-on experience in planning, copywriting and media management.

7. Good communication & interpersonal skills (with both internal and external stakeholders).

8. Good project management skills on planning, execution, agency management, creativity, cross-function coordination.

If you are interested in this position, please send an email with your resume to talent@zailaboratory.com

(Sr.) Direcor,Biologics Pilot Plant

Pilot Plant
Suzhou

Job Description:

1) Oversees the development and maintenance of an established system to show the hierarchy of plans and schedules; keeps project and company management fully informed and be able to prioritize tasks assigned to pilot plant.

2) Coordinates staffing requirements, assigns and supervises project work activities, and trains personnel.

3) Completes performance reviews and provides personnel development for the assigned employees and support yearly manufacturing budgeting efforts.

4) Participates in business development efforts by gathering and presenting a variety of background data. May be required to make informal or formal presentations.

5) Leads capability assessment and activities to drive continuous improvement in the site operations.

6) Responsible for building plan and execution of cost saving plans.

7) Critical participant on Risk Assessments for new product manufacturing processes.

8) Oversee Sites Health, Safety and Environmental programs, as well as Reliability and Sanitation workstreams.

Qualifications:

1) MS or Ph.D. (preferred) degree in Biology, Biochemistry, Chemical Engineering, or related field (or equivalent work experience)

2) 8-12 years of related experience in pharmaceuticals or Biotech, proven cGMP knowledge and working experiences, as well as strong team management experience in a supervisory position for at least for 8 years.

3) Proficient PC skills including a proficiency in various Project Controls Software and Microsoft Office Suite.

4) Proven ability to perform in a supervisory capacity, as well as thorough knowledge of industry practices is required.

5) Good English skills in writing, reading, and speaking as plus.If you are interested in this position, please send an email with your resume to talent@zailaboratory.com 

ProductManager-Zejula

Marketing
Shanghai

Job Description:

 Understand overall brand strategies of owned product.

 Explore the insight and contribute to brand plan and budget control.

 Build the brand image in nation and provide direction and insight related to tactical thought of regional market issues.

 Identify regional opportunities and potential trend through regional market data interpretation to improve the market share.

 Lead the brand key pilot rolling out and execution of regional unique activities.

 Identify marketing competitor landscape, provide regional competition strategy and implementation plan.

Qualifications:

 Master’s degree or above on pharmaceutical, clinical medicine or clinical medicine related with outstanding English.

 At least 5 years working experience in marketing position.

 At least 2 years in TA of ONCO or specific drug, digestive field is preferential.

 Excellent market analytical & problems’ solving skills with strong planning skill.

 High logicality with quick learning capabilities and a good work ethic with strong communication and interpersonal skills.

 Capability to work under pressure & perform duties with high quality timely.If you are interested in this position, please send an email with your resume to talent@zailaboratory.com 

NGOManager

GAD
Shanghai

Job Description:

1. Select and evaluate NGO, engage key stakeholders of qualified NGO and internal functions to get all preparation on time, including donation scheme, inclusion criteria, donation goods supply and donation agreement, etc., and launch patient support program on schedule.

2. Collaborate with NGO and external vendors to set up PAP infrastructure, including PAP SOP, build nationwide network, importation and distribution channel, online platform, physician and pharmacist register and training, problem solving and so on, to provide premium service for patients.

3. Implement Zai Lab patient strategies and monitor projects (incl. plan and budget) to ensure objectives are met and project execution in compliance by working with internal cross-functional team (incl. MKT, sales, Medical, Legal, Compliance, Supply chain, etc.) and external partners/vendors (incl. patients, HCPs, public, NGOs, patient group, etc.).

4. Develop PAP forecast model, support Foundation and external vendors to conduct tax exemption (as needed), clearance and drug inspection, and monitor the inventory of donation goods at both distributor and DTP pharmacy level, to ensure donation supply on time with expected quantity, and in compliant with rules and regulations.

5. Build up relationship with third parties, for example, charity foundation, micro-financing, commercial insurance companies, key medical experts, DTP pharmacies and patient advocacy groups, etc., identify collaboration opportunities and initiate innovative Patient Support Programs, including patient education, patient financial and insurance support, and patient advocacy upon patients’ needs to continually improve patient access.

6. Support central/local Market Access team to achieve local access breakthrough through local and national reimbursement negotiation as needed.

7. Complete other assigned works in time.

Qualifications:

1. Bachelor degree or above, major in pharmaceutical. Clinical medicine or related.

2. At least 2 years’ working experience related to PAP or marketing.

3. Big pharmaceutical company background is a plus.

4. High logicality, result oriented, a good work ethic with strong communication and interpersonal skills.

If you are interested in this position, please send an email with your resume to talent@zailaboratory.com

Scientist,phage display

Discovery
Shanghai

Job Description:

1) Carry out various tasks to support antibody lead selection and optimization.

2) Be capable of multi-task processing and work on various projects in parallel.

3) Execute experiments to generate monoclonal antibodies, including plasmid design and construction, library generation and screening, antibody expression and purification, etc.

4) Communicate with colleagues or CROs to solve project related issues or challenges.

5) Interpret and summarize experimental data.

6) Maintain appropriate experimental records and documentation.

Qualifications:

1) Master in a biological science plus at least 2 years’ industrial experience in antibody discovery.

2) Strong background in molecular biology is required and experiences in phage or yeast display are highly preferred.

3) High accountability, collaborative and proactive attitude with multi-task ability.

4) Excellent attention to detail, strong documentation skills, and ability to communicate effectively.

If you are interested in this position, please send an email with your resume to talent@zailaboratory.com

Scientist,Hybridoma

Discovery
Shanghai

Job Description:

1) Contribute to antibody discovery goals utilizing hybridoma technology for different programs.

2) Participate in project planning activities including immune strategies and screening cascades design.

3) Execute experiments to generate monoclonal antibodies, including mice/rat immunization, serum titer evaluation, hybridoma fusion and culture, screening of antibodies, sucbcloning, hybridoma expansion, cryopreservation, antibody purification and other assignments as required.

4) Be capable of multi-task processing and work on various projects in parallel, and responsible for trouble shooting and delivery task in timely manner.

5) Interpret and summarize experimental data, present results at project meeting.

6) Maintain appropriate experimental records and documentation.

Qualifications:

1) Good experience with antibody generation using hybridoma technology is a must.

2) Strong experience with antibody binding assays, especially ELISA and FACS is required.

3) Experience with transgenic animals, high-throughput automation, molecular biology, hybridoma sequencing and B-cell cloning is a plus.

4) High accountability, collaborative and proactive attitude with multi-task ability.

5) Proven abilit.y to work independently, troubleshoot, interpret and report data.

6) Excellent attention to detail, strong documentation skills, and ability to communicate effectively.

If you are interested in this position, please send an email with your resume to talent@zailaboratory.com

Scientist,Monoclonal Antibody Purification Process

Discovery
Shanghai

Job Description:

1.Lead and participate in the activities include upstream process development, Amber15/Amber250/3L bioreactor/15L bioreactor cell culture process development and DOE experiments.

2.Lead and participate in documents preparing, revising, and management of upstream process development department.

3.Lead and participate in upstream process characterization and validation jobs.

4.Make 15L or 50L bioreactor production according to the manufacturing plan, include documents preparation, material preparation, buffer preparation, process operation, and so on.

5.Upstream process development cooperation, site management and training.

Qualifications:

1)Master degree or Ph.D in biology, pharmacy, etc.

2)3 years+ experience in cell culture process development for monoclonal antibody or bispecifics.

3)Work conscientiously and responsibly, with good professional quality and team spirit.

4)Good listening, speaking, reading and writing skills of English.
If you are interested in this position, please send an email with your resume to talent@zailaboratory.com 

Scientist,Cell Line & Process Development

CMC
Shanghai

Job Description:

1.Lead and participate in the activities include upstream process development, Amber15/Amber250/3L bioreactor/15L bioreactor cell culture process development and DOE experiments.

2.Lead and participate in documents preparing, revising, and management of upstream process development department.

3.Lead and participate in upstream process characterization and validation jobs.

4.Make 15L or 50L bioreactor production according to the manufacturing plan, include documents preparation, material preparation, buffer preparation, process operation, and so on.

5.Upstream process development cooperation, site management and training.

Qualifications:

1)Master degree or Ph.D in biology, pharmacy, etc.

2)3 years+ experience in cell culture process development for monoclonal antibody or bispecifics.

3)Work conscientiously and responsibly, with good professional quality and team spirit.

4)Good listening, speaking, reading and writing skills of English.

If you are interested in this position, please send an email with your resume to talent@zailaboratory.com

Software Engineering (Associate)Manager

IT
Shanghai

Primary Function:

- Response for system architecture, development and code

Major Responsibilities and Duties:

- Response for system technical architecture design, prototype design and function design

- Response for core function development;

- Response for system enhancement development;

- Response for source code quality review and control;

- Response for progress of development project;

- Response for Zai Lab's SLDC system establishment

- According to the company's information security management requirements, comply with all the company's information security policies, processes and perform duties as required to protect the security of the company's information assets

Qualification:

- Bachelor's degree or above in computer related major

- At least 8 years working experience in Software development with C#, Java, pharmaceutical industry experience is a plus.

- Web based thick client's development, designing and coding, testing and troubleshooting.

- Should have strong experience working with Java, .Net, ASP.NET MVC, Web API, C#, Entity Framework, MS SQL Server, MySQL.

- Have strong sense of responsibility, learning ability and execution, solid and good communication ability and service awareness

- Good communication skill and problem-solving oriented, have certain pressure resistance ability

(Sr) IT Engineer –Infrastructure

IT
Shanghai

Primary Function:

- Operation of the servers/network (50%): perform daily operations for requests/changes/incidents on various IaaS/PaaS/SaaS systems, on-premises servers, network devices.

- Operation of the backup/restore, system monitoring (30%): perform daily backup/restore operations for various clients on Cloud/NBU/tape libraries; daily monitoring for server/network/service/security and take actions.

- Implementation of the infrastructure projects (20%): support implementation of infrastructure projects, or application projects as an infra functionary.

Major Responsibilities and Duties:

1) Daily maintenance and support (level 2 or 3) for company's Windows/Linux servers and the modern workplace, including installation, configuration, migration, fault diagnosis, etc.

2) Responsible for cloud setup, configuration operations, maintenance and backup, ensuring that servers are running with highly available.

3) Responsible for monitoring and performance optimization on IT infra environments.

4) Responsible for backup managements on our on-premises servers, workstations and cloud servers.

5) Responsible for management of accounts/permissions/groups/security on AD/AAD/O365 as per requirements.

6) Manage VMware virtualization and Hyper-V system.

7) Support new infrastructure projects in the greater China region.

8) Document all records of server daily operations, backup/restore, monitoring, etc. following by SOPs.

9) Onsite support for end users as level 2 of Service Desk.

10) Other duties as assigned by line manager.

Qualification:

1) Bachelor’s degree or above, major in INFORMATION technology or computer science or other related fields.

2) 2+ years of IT service management and process implementation experience; 2+ years of technical experience on VMware/Hyper-V virtualization; 3+ years of server and network management experience; 1+ years of cloud management experience; 2+ years’ experience in the life sciences company.

3) Good analytical & problem-solving skills with minimal supervision, ability to work on own initiative.

4) Good multitasking skills and abilities Flex with changing priorities.

5) Good written and verbal communication skills. Fluent oral English.

6) MCSE, RHCE, CCNA or relevant certificates are preferred.

 


IT Manager(R&D)

IT
Shanghai

Primary Function:

- Analyzes business requirement to provide necessary solution to Discovery function.

- Solution development in respective function area, manage the operations for all service and system in scope.

Major Responsibilities and Duties:

- Act as primary IT contact in respective function area.

- Identify new system demand by fully understanding business objective, business requirement, standard and regulation.

- Ensure system stability and data integrity.

- take accountability to maintenance high level of customer satisfaction.

- Play a key role on identifying continuous improvement opportunity on responsible function area.

- Provide supporting on validation, testing and installation for assigned function area system.

- Ensure managed system operation aligned with requirement of IT and information security standards.

- Identify root cause of application problem and avoid recurrences.

- Design, develop and provide user training for responsible systems, include maintaining training manuals.

- Build close collaboration with key internal& external stakeholder.

- Perform application administration on assigned system.

- Provide input on demand requirement for creation and maintain IT investment plan.

- Take IT PM role for assigned application implementation project.

Qualification: 

1) Degree in Information Systems or comparable education/ experience

2) Fluent in English (Oral and Written)

3) At least 5 years of experience in pharma R&D area

4) Knowledge on discovery lab or clinical solution IT system.

5) Familiar with R&D application system: ELN, SDMS, LIMS, Argus, Mosaic, CDS, etc.

6) Pro- active, patient, work well in a team environment.

7) able to work independently over customer complain.

8) Willing to learn new technology.

 

Sr IT Business Analyst(focus on Clinical RA PV)

IT
Shanghai
Primary Function:

- Project responsibilities:
  Act as IT PM role for conducting application implementation project including evaluation of capability of vendor, product and service, coordination with vendor and business functions to ensure .

 - Operation responsibilities:

  Act as system manager role for managing security configuration e.g. access control, system configuration e.g. template, business flow, configurable functionality, report generation.

  Handle routine quality activities e.g. change control, deviation, CAPA, computerized system validation and computerized system quality management according to SOPs, guidelines and regulations.

Major Responsibilities and Duties:

1. Act as primary IT contact in respective function area.

2. Identify new system demand by fully understanding business objective, business requirement, standard and regulation.
3. Ensure system stability and data integrity.

4. Take accountability to maintenance high level of customer satisfaction.
5. Play a key role on identifying continuous improvement opportunity on responsible function area.

6. Provide supporting on validation, testing and installation for assigned function area system.

7. Ensure managed system operation aligned with requirement of IT and information security standards.

8. Identify root cause of application problem and avoid recurrences.

9. Design, develop and provide user training for responsible systems, include maintaining training manuals.
10. Build close collaboration with key internal& external stakeholder.

11. Perform application administration on assigned system.

12. Provide input on demand requirement for creation and maintain IT investment plan.

Skills:

- 3+ years of experience working in a pharmaceutical or regulated environment

- Must have experience working on IT Systems in a regulated environment

- Hands-on experience in implementing, management and validation of GxP computerized systems

- Specific system administration experience in clinical, R&D, RA and PV business is preferred,such as CTMS, eTMF, PV, eCTD etc.

- Strong understanding of regulations (NMPA/FDA/EMA) and guidelines(GAMP)

Education:

- Bachelor’s Degree in Computer Science or relevant

- Good spoken and written English skills

Manager,Clinical Pharmacology (Bioanalysis)

Early Development
Shanghai

Job description:

- Collaborate with line management in setting the BA outsourcing strategy and providing the timeline coordination for clinical studies.

- Partner with QA and CP colleagues to identify and qualify the BA CROs, and coordinate CROs in terms of protocol drafting, study monitoring and report delivery to ensure timely and smooth workflow and in the meantime to ensure guidance are met all along.

- Leading the BA team and engage with CROs for trouble-shooting and continuous improvement to deliver against all agreed BA objectives.

- Provide scientific input and represent clinical pharmacology group in project teams, including timely written and oral communication of program related issues to multidisciplinary teams and raise up the solutions from BA perspective.

- Supporting the regulatory inspections or audits for Zai Lab sponsored studies, and address the queries from regulatory agency timely.

- Contribute to a positive and cohesive work environment that fosters teamwork, innovation and professional development.

Basic Requirements:

1) Master or Ph.D. degree or equivalent in a life/biological science or quality-related field, or equivalent combination of education, training and experience.

2) At least 5 years working experience in pharmaceutical industry and demonstrated BA/PK expertise.

3) Thorough understanding of bioanalytical assays, including the PK, ADA and Nab assays. Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.

4) Excellent interpersonal, leadership & organizational skills to negotiate priorities with stakeholders and help foster a collaborative environment with colleagues across sites and across disciplines.

5) Excellent/accomplished communication skill, facilitation, influencing, and strategic thinking skills within the organization, good at data analysis and presentation.

6) Ability to proactively identify issues, propose solutions and troubleshooting, and work in a team as well as to work independently with limited guidance or supervision

7) Good English (written and spoken) and Chinese

Preferred Requirements:

Relevant to the role, but not critical/essential

- Much experience with regulatory authority inspections

- Experienced for large molecule bioanalysis.

- Experience with clinical pharmacology knowledge.


(Senior) Specialist,Data Management

Medical
Shanghai
Job Descreption:

- Manage / assign responsibilities for Data Managers and also serve as a member of Study Teams. Act as primary Data Management contact and contributor for projects.
- Liaise with CROs, EDC vendors and other third-party vendors in a project-manager capacity in support of timelines and data-related deliverables.

- Create / monitor timelines and ensures that all deadlines are met with quality.

- Participate in the review of clinical data, analysis tables, listings, figures, and patient profiles for data consistency and accuracy.

- Identify and troubleshoot operational problems and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.

- Review and provide feedback on protocols, Statistical Analysis Plans, etc.

- Develop and support creation of data management
documentation, specifications and UAT requirements for database and test according to UAT Plan.

- Create, review and revise data management documentation.

- Ensures data management activities are conducted in accordance with GCP, GCMP, internal SOPs, and meet all regulatory requirements.

- Identify project challenges and risks, and proposing appropriate and strategic solutions to issues.

Qualifications:

- BA or BS degree in a health-related field preferred.

- 0-3 years of related experience in clinical data management in the Pharmaceutical, Biotechnology industry or equivalent.

- Electronic data capture experience (Medidata Rave) and working knowledge of Oncology indications.

- Proficient in data management activities including CRF and clinical database design, clinical data cleaning and analysis for Oncology trials.

- Overall understanding of ICH, GCP, CDISC and other applicable regulatory guidelines as they pertain to data management.

- Knowledge of SDTM models and experience transforming raw data into those standards.

- Knowledge of Data Management and Pharmacovigilance processes in clinical trials.

- Knowledge and coding experience using MedDRA and Who Drug dictionaries.

(Associate) Manager,Clinical Ops Process Development

Clinical Operations
Shanghai

Major Responsibilities and Duties:

CTMS and eTMF Management

- Ensure the system set up in consistent to Zai’s internal SOP requirements.

- Specialist to provide support to end users and Administrators.

- Management Q&A of CTMS/eTMF.

- CO internal access and role management.

- Oversight of related system vendor.

CO Internal Process Improvement

- Continuous improvement and troubleshooting of CO internal process.

- Support to develop SOP, WI and/or tool documents to optimize CO process.

- Enable adaption and justification of updated SOP and WI.
Qualifications:

- At least 2 years working experience in clinical trials, CTA, CRA or Project Manager. Previous working with CTMS and/or eTMF system is preferable.

- Excellence communication skill, good in English reading and writing. Interpersonal skill and presenting skill in front of cross function audience is a prior.

- Bachelor degree in medicine, nursing, pharmacology, or pharmaceutical science.

HR Assistant人力资源助理

HR
Shanghai

Job Description:
- Provide admin and operation support to HRVP and HR team, including meeting coordination, reimbursement, event coordination, travel arrangement etc.

- Documents, profile and data preparation and management.

- Other admin and operation work assigned by HRVP and team.
Qualifications:

- Bachelor Degree or above, English Major with Tem 8 is preferred.

- 2 year working experience, biopharma experience is a plus.

- Proactive, responsible, work with strong sense of efficiency, good planning.

- Proven communication skills and good team player.

- Good at thinking and problem solving.

- Knowledge of Office.

- Knowledge of HR is a plus.

SeniorClinical Project Manager

Clinical Operations
Mainland China
Job Description:

1) Plans and executes trial level project management activities for assigned studies including trial level timelines, risk assessment, mitigation plans, and other aspects of trial level project management (e.g. budget, metrics).

2) Leads study team meetings.

3) Develops and tracks overall trial timeline and gains alignment with affiliates and team members on milestone dates.

4) Ensures data compliance at the trial level to achieve country and site level compliance, as appropriate.

5) Manages relationships and serves as the focal point of communication between internal and external clinical research partner at the trial level.

6) Productively identifies and communicates appropriately the status of ongoing projects, Issues, and risks that may affect the critical path of the clinical trial and project schedule.

7) Reviews sourcing alternatives, provides necessary study specific actions in order to obtain reliable study costs, staffing strategy, and timeline projections.

8) Provides oversight of CRO performance throughout study implementation.

9) Develops study training and may also coordinate/deliver training, as appropriate.

10) Obtains clinical trial cost forecasts. Establishes and monitors the trial budget.

11) Manages and tracks trial enrollment.

12) Coordinates proposal reviews with third party vendors, and provides input regarding needed changes in contract conditions.

13) Anticipates, manages, and escalates Issues as appropriate.

14) Maintains and archives at trial level documentation.

15) Partners with study team in the management of data locks (final and interim) and site closure.
Qualifications:

1) Bachelor's degree in a scientific or health related field.

2) Comprehensive understanding of Good Clinical Practices, Good Documentation Practices, CFDA regulations.

3) Excellent interpersonal skills and demonstrated business acumen with an ability to interface successfully with physicians and their staff, executive management, and cross-functional teams and individuals.

4) Excellent verbal and written communication skills.

5) Excellent office computer skills, including experience with clinical databases.

6) Effective cross-functional team player with ability to work in a team environment.

7) Demonstrated leadership skills.

8) Excellent project management and organizational skills; able to handle multiple tasks/projects and manage priorities accordingly; with a high tolerance for ambiguity.

9) Experienced in serving on product development teams and understands the product development lifecycle.

AssociateClinical Project Manager

Clinical Operations
Mainland China

Job Description:
1) Plans and executes trial level project management activities for assigned studies including trial level timelines, risk assessment, mitigation plans, and other aspects of trial level project management (e.g. budget, metrics).

2) Leads study team meetings.

3) Develops and tracks overall trial timeline and gains alignment with affiliates and team members on milestone dates.

4) Ensures data compliance at the trial level to achieve country and site level compliance, as appropriate.

5) Manages relationships and serves as the focal point of communication between internal and external clinical research partner at the trial level.

6) Productively identifies and communicates appropriately the status of ongoing projects, Issues, and risks that may affect the critical path of the clinical trial and project schedule.

7) Reviews sourcing alternatives, provides necessary study specific actions in order to obtain reliable study costs, staffing strategy, and timeline projections.

8) Provides oversight of CRO performance throughout study implementation.

9) Develops study training and may also coordinate/deliver training, as appropriate.

10) Obtains clinical trial cost forecasts. Establishes and monitors the trial budget.

11) Manages and tracks trial enrollment.

12) Coordinates proposal reviews with third party vendors, and provides input regarding needed changes in contract conditions.

13) Anticipates, manages, and escalates Issues as appropriate.

14) Maintains and archives at trial level documentation.

15) Partners with study team in the management of data locks (final and interim) and site closure.
Qualifications:

1) Bachelor's degree in a scientific or health related field.

2) 5+ years clinical research or relevant experience.

3) Comprehensive understanding of Good Clinical Practices, Good Documentation Practices, CFDA regulations.

4) Excellent interpersonal skills and demonstrated business acumen with an ability to interface successfully with physicians and their staff, executive management, and cross-functional teams and individuals.

5) Excellent verbal and written communication skills.

6) Excellent office computer skills, including experience with clinical databases.

7) Effective cross-functional team player with ability to work in a team environment.

8) Demonstrated leadership skills.

9) Excellent project management and organizational skills; able to handle multiple tasks/projects and manage priorities accordingly; with a high tolerance for ambiguity.

10) Experienced in serving on product development teams and understands the product development lifecycle.

Principal/Senior Biostatistician资深/高级生物统计师

Medical
Shanghai

Primary Function:

The Principal Biostatistician partners with clinical, safety, regulatory, operation, data management, programming, and marketing affairs on clinical development projects, research applications, development science applications, and/or post-marketing requirements. This typically includes partnering with senior scientists independently in the creation of clinical development plans and having primary strategic and operational responsibility for the design, conduct, and evaluation of experiments. For clinical development programs, principal statistician can serve as lead Biostatistics representative on cross-development clinical study teams and project teams

Major Responsibilities and Duties:

1) Participate in new drug development programs as a Subject Matter Expert (SME) in statistics area. Provide statistical leadership for clinical development projects, including working on statistical designs and also providing strategic input into other aspects of clinical development plans and target product profiles.

2) Directly responsible for the statistical integrity, adequacy, and accuracy of the clinical studies within the project, including activities to work with cross-functional representatives to work on study planning, study conduct, analyses and reporting.

3) Produce the following study-related deliverables, either personally or by supervising CROs: appropriate sections of study protocols, statistical analysis plans, data monitoring committee charters, data analyses, and sections of clinical study reports and registration documents.

4) Keep abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program.

5) Participate in development of standard reporting programs for clinical studies.

6) Participate in development of standard CRFs for clinical data collection.

7) Participate in regulatory submissions including CSR, IND safety update, Annual Report/DSUR, and integrated summaries of safety and efficacy in NDA and BLA.

Qualifications:

1) For Principal:A minimum of 3 years for Ph.D. (6 years for MS) working experience in pharmaceutical and/or Biotech Company and/or related institutes.

For Senior:MSc with a minimum of 3 years working experience in in pharmaceutical and/or Biotech Company, or PhD in statistics, biostatistics, mathematics or similar areas of academic discipline.

2) Good knowledge of theoretical and applied statistics.

3) Good written and interpersonal communication skills with English in a business environment.

4) Proficient in using statistical software, such as R or SAS.

5) Good knowledge of statistical methods in clinical study designs, clinical data analyses. including statistical procedures in analysis software.

6) Advanced Knowledge of statistical analysis methods and results/data presentation formats of clinical data.

7) Good knowledge of regulatory regulations and guidance.

8) Good understanding of clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation.

9) Must have worked on statistical analysis plans, study protocols and clinical study reports.

10) Preferably, worked on IND or CTA or NDA.

11) Preferably, worked on oncology clinical trials.

12) Ability to exhibit exemplary experimental technique, following procedures with the utmost rigor and attention to detail.

13) Ability to complete complex tasks in a timely manner with a minimal supervision.

14) Highly motivated and able to work well under pressure and shifting priorities independently and as a team member.

If you are interested in this position, please send an email with your resume to talent@zailaboratory.com

Principle Scientist,Medicinal Chemistry

US Discovery
San Francisco Bay Area

Zai Lab is seeking a skilled Medicinal Chemist to drive small molecule discovery projects on oncology targets, from project evaluation, developing and implementing chemistry strategy for hit identification and lead optimization through to selection of preclinical development candidate. The successful candidate will be a member of a fast-paced and interactive research team contributing to the discovery and development of novel therapeutics. 

Organizational Relationships:

The Principal Scientist reports to the Head of Medicinal Chemistry, and collaborates extensively with DMPK, in vitro Biology and in vivo Pharmacology teams. He or She will oversee outsourced activities and manage internal resources.

Responsibilities:

- Initiate and drive chemistry of one or more small molecule drug discovery projects. Apply a wide variety of drug design concepts, and organic and medicinal chemistry skills in the design and synthesis of novel molecules as potential drug candidates

- Assist in choosing new biological targets and contribute to overall corporate medicinal chemistry strategy

- Closely follow emerging results of biological testing, ADME characterization, and other lead profiling assays; Proactively propose new strategies to improve key attributes and work collaboratively with cross-functional project team to overcome project hurdles. Drive SAR optimization cycle to achieve project goals.

- Coach junior chemists. Provide supervision and guidance to direct reports

- Manage external chemistry resources by setting up direction and priorities, as well as by monitoring progress, quality and timeline

- Proactively seek out new information in the literature and incorporate into individual project(s) as well as the overall program

- Be responsible for inventory upkeep, data tracking and archiving, and supply ordering

- Participate in intellectual property analysis and contribute to patent generation and application preparation

- Communicate effectively within project teams. Present chemistry strategy, plan and progress at project team meetings.

- Contribute to fostering a culture that embraces continuous learning and improvement and open communication; take a proactive role in scientific development and personal growth

Qualifications:

- Ph.D. in organic or medicinal chemistry and a minimum of 5-10 years' experience, or MS with 8-10 years' relevant experience in a high-performing biotech or pharma with solid knowledge of modern synthetic methodology

- Demonstrated success in lead identification and lead optimization, delivering multiple novel molecules into preclinical and clinical development. Solid experience in structure-based drug design

- Project leadership experience driving team through lead optimization and selection of development candidate

- Solid understanding of various scientific disciplines in addition to medicinal chemistry, including biochemistry, DMPK, and toxicology.

- Knowledgeable about molecular attributes that can enhance success in early development and beyond

- Demonstrated ability to resolve key scientific hurdles by effectively utilizing available information and technical expertise

- Strong track record of productivity, as evidenced by driving project forward and robust publications and patents

- Excellent written and oral communication skills; ability to present chemistry strategies and progress to internal team, and to communicate effectively with external partners.

- Strong team spirit and interpersonal skills. Ability to work collaboratively in a cross-functional team setting, as well as with CROs and external partners.

- Desire and initiative to learn and tackle new challenges. Highly motivated and flexible with ability to work in fast-paced, goal-driven environment.

If you are interested in this position, please send an email with your resume to talent_us@zailaboratory.com

TTFields Sales Executive肿瘤电场治疗销售代表

TTField Business Unit (HK)
Hong Kong

Job Overview

We are looking for a competitive pharmaceutical sales representative who can thrive in a fast-paced business environment. The pharmacy sales rep will act as the key link between our company and healthcare professionals and you will aim at meeting sales targets.

Responsibilities and Duties

-  Promote key products to current and potential clients in HA & private Sectors

-  Achieve product and company sales targets and business objectives

-  Establish and implement sales plans according to overall sales and marketing strategies

-  Identify opportunities for new business

-  Develop and maintain rapport relationships with KOLs and key accounts, with clear prioritization and focus

-  Support new product launches and other PR / marketing programs and activities 

-  Effectively utilize sales tools and provide high quality in-service / product demo to familiarize customer product usage

-  Perform case follow-up

-  Gather market intelligence and feedback on a regular basis

-  Ensure adherence to company policies, procedures and business ethics

-  Perform ad hoc projects as required

Qualifications

-  University graduate, preferably degree holder in science related discipline

-  At least 5 years of sales experience in pharmaceutical or healthcare industry, with 2 years in Oncology field is   highly preferred

-  Outgoing, patient and friendly character with strong communication and problem-solving skills

-  Fluent Cantonese & good English

-  Good team player

-  Proactive, motivated and committed self-starter

-  Proven sales track record

If you are interested in this position, please send an email with your resume to talent@zailaboratory.com

Medical Affairs Manager / Associate Manager医学事务经理/副经理

Medical Affairs
Hong Kong

Job Overview

Works with team head to execute medical affairs strategies and complete medical affairs projects cope with our upcoming pipeline launches.  Focus of responsibilities can be on any part of the product lifecycle from research through the on-market phase. Activities can include development of key medical and research contacts across a variety of disease state areas, development and implementation of clinical study protocols, development and execution of clinical studies, medical input/support for product development, medical support for customer inquiries and medical assessment of on market product issues. Must be able to review, synthesize data clearly and present conclusions to medical directors. Will need to be able to work independently, within an internal cross functional team and with external partners.

Responsibilities and Duties

KOL Management & Medical Support:

1. Contributes to mapping / profiling of KOLs/decision makers in line with segmentation.

2. Develop professional relationships, with KOLs/decision makers.

3. Collect, analyze and report insights that may impact Zai Lab development plans /trial designs.

4. Provide and discuss scientific information and data to healthcare professionals to ensure quality and accuracy of medical and scientific information on new treatment options including Zai Lab products and selected areas of therapeutic interest.

5. Liaise and provide up-to-date medical support to relevant external groups to facilitate listing of products in medical guidelines, formularies to impact pricing and health-economic discussions.

6. Provide speaker training to health care professionals to support the best use of new therapies developed and commercialized by Zai Lab.

7. Compliance: Ensure products are all comply with all applicable laws and local/global safety responsibilities

8. Assist the Corporate Communication in handling media issues & enquiries, particularly those medically related.

9. Assist and enhance the generation of high quality, impactful publications and collateral material that conform to the appropriate standards and regulations

10. Support implementation of pre-launch studies for PI and site selection.

Clinical Development Support:

1. Contribute to the identification of appropriate clinical investigators and facilitates placement into Zai Lab sponsored clinical trials.

2. Support the investigational sites, as needed, as part of a cross-functional team with Clinical Operation and the Medical Advisor and others as appropriate.

3. Identify clinical investigators with research proposals that are consistent with our product development strategies and facilitate the Investigator-Initiated Trials (IIT) process including study completion, presentation, and publication, as appropriate.

4. Support the investigators to comply with the IIT process in accordance with the guidelines, providing knowledge and guidance for legal and financial local regulations, as appropriate.

Information Management/Insights:

1. Collaborate with Zai Lab colleagues to actively support medical and scientific meetings by collecting and interpreting insights /presentations/ results.

2. Evaluate the impact of competitive information to share internally and externally as post-meeting deliverables.

Internal Support:

1. Provide medical support and training (i.e. disease state and product) to Zai Lab colleagues (e.g. sales reps, CRAs, etc.).

2. Screen business opportunities.

3. Serve as a resource for projects and collaborate with internal colleagues.

4. Collaborate with Medical Teams and other cross-functional groups (i.e. Business Franchise Teams, Market Access).

Qualifications

1. University graduate in medical science, pharmacy, pharmacology or related discipline.

2. At least 3 years' experience in medical affairs in pharmaceutical industry.

3. Knowledgeable of regulatory and compliance regulations and guidelines relevant to the industry

4. Prior experience establishing and maintaining long term relationships with customers and key thought leaders through scientific engagement

5. Experience to delivering effective, high quality scientific presentations and communicate scientific data to both internal and external customers

6. Ability to work in a fast paced and dynamic environment

7. Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.

8. Strong communication and presentation skills

9. Self-starter

    a)  Driven to perform

    b)  Self-directed: needs little explicit direction

10. Able to organize, prioritize, and delegate tasks to efficiently move projects forward.

If you are interested in this position, please send an email with your resume to talent@zailaboratory.com

Senior Manager, Medical Information高级经理,医学信息

Medical Affairs
Shanghai

Major Responsibilities and Duties:

1.Working with team to contribute for professional information strategy development.

2.Making alignment of professional information strategy, plans and activities within organizations.

3.Be responsible for budget tracking and reporting to the relevant MI issues. Monitor timeline and manage project to conclusion and implementation.

4.Provide medical information and literature search for KOLs, HCPs and internal customers, analysis literature request to provide insight for medical and business plan.

5.Competitive Intelligence surveillance, analysis and timely report, provide CI information for medical and business decision and plan.

6.Lead digital medical service for internal and external customers.Any other responsibilities and duties which may be required from time to time.

Qualifications:

1.Bachelor and above degree. Academic background with a medical related degree is preferred.

2.5+ yrs working experience on medicine, pharmacy or pharmaceutical industries.

3.Familiar with the medical information work.

4.Good time management.

5.Good collaborative skills.

6.Good computer using skills.Fluency in both written & spoken English.

If you are interested in this position, please send an email with your resume to talent@zailaboratory.com

(Senior) Marketing Manager(高级)市场经理

ONCO Marketing
Shanghai

Primary Function:

As a key person in Central Marketing Function, you will be working on the analysis on central market for the business potential and opportunity by central level. Accordingly, you will develop Optune marketing plan and effectively communicate with KOLs and sales team to make sure it is appropriate to the market. Besides, you will be executing on marketing activities like VIP events and any other society congress with good budget control with the developing and maintaining of Optune KOLs and speakers.

Major Responsibilities and Duties:

1.Support OPTUNE Launch Lead in developing and executing pre-launch and launch strategies and plan execution for the GBM Neurosurgery/Radiation/Oncology Department.

2.Use a broad set of channels (e.g. surveys, field visits, KOL relationships) to gather deep customer insights to gain holistic understanding of the patient journey and what motivates and drivers customer behavior.

3.Develop brand strategy including positioning & marketing messages and communication materials that are consistent with the product positioning and product strategy.

4.Develop creative product/brand campaigns/GBM neurosurgery platforms reinforcing the positioning and SoV.

5.Understand and track national KOLs’ opinions and develop neurosurgery department advocates for TTF treatment.Collaborate with sales team to deliver the sales revenue align with the budget.

Qualifications:

1.Bachelor degree or above on pharmaceutical, clinical medicine or clinical medicine related with outstanding English.
2.At least 5 years working experience in pharmaceutical company with marketing GBM related area is preferred.

3.At least 3 years in TA of ONCO or specific drug.

4.Marketing experiences with top 10 pharmaceutical company would be highly preferred.

5.Excellent market analytical & problems’ solving skills with Strong planning skill.

6.High logicality with quick learning capabilities and a good work ethic with strong communication and interpersonal skills.Capability to work under pressure & perform duties with high quality timely.

If you are interested in this position, please send an email with your resume to talent@zailaboratory.com