Senior Director, Clinical Pharmacology
Summary
Lead the clinical pharmacology (CP) group of ~10 members, including clinical pharmacologists, pharmacometricians and toxicologists, to support global and/or regional development projects, ensuring all deliverables are based on science with high quality and timeliness.
Responsibilities
- Provide CP expertise and guidance in clinical drug development programs of all therapeutic areas in study design (including dose rationales), data analyses to learn dose-exposure-response relationships and their variabilities, result interpretations and reporting
- Supervise and work with pharmacometricians in conducting PK (and/or PD) analysis (e.g., to integrate all regional data and investigate ethnic differences) for regulatory submissions in China
- Engage with management, regional and global (internal and external) stakeholders to drive CP strategies at project and portfolio levels
- Establish best practices for CP processes activities (e.g., modeling and simulation) to seek efficiency. Implement and explore process and data analysis strategies including AI/ML for science/innovation and for productivity
- Guide CP members in career development; coach and train junior members in applying quantitative methods and PK-PD knowledge to clinical projects
Qualifications
- Ph.D/PharmD/MD in relevant disciplines (CP, pharmacokinetics [PK], , toxicokinetics, pharmacometrics) or other equivalent degrees or knowledge/expertise
- 8+ years of relevant clinical development experience in CP or Modeling & Simulation (M&S) roles
- Adequate people management experience with proven track records as a coach/trainer
- Excellent communication and negotiating skills with fluent in English (oral and written)
- Decent scientific publication records
Skills
- In-depth understanding of CP, pharmacometrics, and their interfaces with (and good understanding of) DMPK, toxicology, biostatistics, clinical development, and regulatory science with quantitative, logical approach to drug development and common sensical business acumen.
- Ability to translate complex quantitative analyses into clear, actionable insights for cross‑functional and senior stakeholders.
- Strong scientific judgment, critical thinking, and decision‑making in ambiguous or data‑limited settings.
- Experience working in global, matrixed organizations with high scientific and regulatory standards. Effective management of stakeholders
Note: position title and compensation mensurate with qualifications and experience.
SD may need at least 8~10 years experiences?