Pharmacometrician/Quantitative Clinical Pharmacologist (Director or Associate Director)
Department: Clinical Pharmacology
Job Title: Pharmacometrician/Quantitative Clinical Pharmacologist (Director or Associate Director)
Report to: SVP, Head of Clinical Pharmacology
This position is responsible for implementing model-based analysis to optimize doses, dosage regimens and study designs, identification of patient and product related factors that impact pharmacokinetics, efficacy and safety, and other clinical and regulatory support for clinical development programs. This position will work closely with CRO partners and provide scientific oversight for population pharmacokinetics, pharmacokinetics/pharmacodynamics, and exposure-response analyses to support all clinical programs. The pharmacometrician in this position should have significant knowledge of pharmacometrics/pharmacology-based modeling to establish quantitative relationship between pharmacokinetics & response (safety, efficacy, biomarker), address product development questions and contribute to clinical pharmacology NDA/BLA packages.
- Responsible for strategy and execution of relevant quantitative analyses which may include population pharmacokinetics, pharmacokinetics/pharmacodynamics, exposure-response, model-based meta-analysis, and decision analysis supporting clinical development projects.
- Collaborate closely with clinical pharmacologist, clinical, stats, data management and programming, and regulatory to ensure modeling and simulation are performed to address critical clinical questions in a timely and efficient manner.
- Work closely with CRO partners to provide scientific oversight for population pharmacokinetics, pharmacokinetics/pharmacodynamics, and exposure-response analyses; independently perform these analyses when needed.
- Review and/or write modeling & simulation analysis plans and reports. Provide input for standard operation procedures and best practices in pharmacometrics.
- Participate in cross-functional project teams and provide quantitative input for dose selection and study designs using modeling and simulation when needed.
- Contribute to the summary documents for regulatory submissions (e.g., integrated summary, briefing books, and regulatory responses).
- Be familiar with literature and regulatory guidelines as relates to pharmacometrics and quantitative clinical pharmacology.
- Ph.D. or equivalent in Pharmacometrics, Clinical Pharmacokinetics, Clinical Pharmacology, or similar disciplines where quantitative pharmacology is emphasized.
- At least 5 years relevant experience.
- Strong quantitative skills with hands-on experience in analyses and tools of pharmacometrics (e.g., NONMEM, R, and Phoenix WinNonlin).
- Relevant regulatory experience (written/oral) in submission and in addressing inquiries from regulatory agencies regarding issues on pharmacometrics.
- Significant demonstrated expertise within the field of quantitative pharmacology including PK, PKPD, and PBPK modeling.
- Demonstrated leadership in understanding of the drug development and in cross functional working.
- Advanced ability to problem-solve and conflict resolution.
- Operational expertise in risk management and contingency planning
- Outstanding oral and written communication skills and ability to interface effectively with all levels.
- Excellent oral and written English; fluent in Chinese; able to independently use both English and Chinese to write documents and communicate with peers and experts.