Responsibilities and Duties:
Primary Function:
Clinical Pharmacology and pharmacometrics
Major Responsibilities and Duties:
Provide comprehensive clinical pharmacology and modeling & simulation (M&S) support for both small and large molecule programs, guiding assets from pre-IND stages through post-approval.
Develop and execute M&S plans to inform critical program decisions. Conduct hands-on PK/PD modeling, including translational PK/PD, population PK, population PK/PD, and exposure-response analyses.
Serve as a subject matter expert (SME) on multi-disciplinary teams. Influence study design, dose selection, and probability of success estimations by effectively presenting and interpreting model-based analyses.
Author and review high-quality clinical pharmacology components for key documents, including protocols, investigator brochures, study reports, regulatory briefing packages, and NDA/BLA submissions.
Contribute to departmental growth by mentoring colleagues and platform setups, evaluating novel M&S methodologies and strategies, and supporting due diligence activities as a SME
Qualifications:
Qualifications:
PhD or MS degree with equivalent experience in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, or other related disciplines.
Sufficient industry or equivalent experience in clinical pharmacology (clinical early development experience is a plus).
Demonstrated ability to work in a highly collaborative, multi-disciplinary and dynamic team setting.
Excellent verbal and written communication skills.
Proficiency in English is a must.
Self-directed and highly-motivated researcher, with willingness to learn new tools and approaches.