Clinical Pharmacology (CP) Scientist

About the Role The Clinical Pharmacology (CP) Scientist develops and implements quantitative CP strategies across early to late phases of clinical drug development to ensure the right drug is administered to the right patient with an optimal benefit/risk profile. The CP Scientist uses state-of-the-art modeling and simulation tools and collaborates with cross-functional teams to support drug development decisions and regulatory filings, with a focus on China development. What You'll Do

• Lead the design and review of clinical study protocols for development of novel therapeutic agents with particular focus on China development (all drug and delivery modalities).
• Lead the planning and conduct of PK/PD data analyses and set strategy to foster the appropriate use of modeling and simulations to inform clinical drug development decisions.
• Represent CP function and lead CP discussions at functional and cross-functional China development focused meetings (internal and external) including governance, scientific conferences, etc.
• Implement strategic agility and effective project management to align critical CP deliverables with evolving regulatory and project needs in China.
• Author regulatory documents and meeting background packages to support key clinical development milestones in China; lead CP representation at health-authority meetings in China and contribute to regulatory filings planning/organization (IND, BLA, NDA, sNDA).
• Support global development strategies for CP and M&S as needed. What We're Looking For
• Qualifications: PhD, PharmD, MD, or equivalent in Pharmacokinetics, Pharmaceutical Sciences, or related quantitative discipline; job level will depend on years of experience and scientific influence.
• The ability to plan, organize, interpret, and perform PK/PD data analyses.
• Familiarity with clinical drug development and study design options for different drug and delivery modalities.
• Working knowledge of quantitative modeling approaches and relevant modeling software (e.g. NONMEM, WinNonlin, R, SimCYP, GastroPlus, PKSim, Matlab).
• Familiarity with agent-based workflows to streamline work streams and improve efficiency in drug development.
• Working knowledge of statistical approaches as applied to clinical study design and analysis.
• Drug development knowledge: CP science impact on development; good knowledge of GCP and regulatory guidelines.
• Scientific leadership: strong leadership and experience representing CP in cross-functional project teams. Nice to Have
• Experience in leading regulatory filing strategy as a CP lead to support the total CP filing package, dose/regimen justification, and drug labeling is highly desired.