Associate Director, Quantitative Clinical Pharmacology

Role Summary

Associate Director, Quantitative Clinical Pharmacology. Location: Cambridge, US. Full-time.

Responsibilities

• Leads the analysis, interpretation and reporting of clinical pharmacokinetic data
• Hands on population PK, ER and PK/PD modeling with corresponding experience with modeling and simulation software (ex. NONMEM, R)
• Drives the necessary PKPD, exposure response and translational modeling and quantitative pharmacology activities to achieve mechanistic understanding of novel drug candidates, and support optimal dose and dosing schedule decisions
• Partners with research leads for the design (analysis plans, project planning) and data analysis/interpretation of pharmacokinetic (PK), toxicokinetic and pharmacodynamics (PD) aspects of preclinical studies to deliver on-time support for key internal and regulatory interactions
• Provides quantitative clinical pharmacology input in regulatory documents (e.g. IB, regulatory briefing book, NDA/BLA)

Qualifications

• Ph.D. in pharmaceutics, pharmacokinetics, pharmacology, pharmacometrics, or related discipline, or Pharm.D. or M.D. with relevant experience. M.S. with requisite experience will also be considered
• Minimum 5 years of experience in the biotechnology or pharmaceutical industry including a strong understanding of early and late drug development process from IND through NDA/BLA
• Direct experience in executing and leading modeling activities in drug development programs, from early exploratory studies to Phase 2/3 programs
• Strong fundamental understanding of PK and PK/PD data in the context of complex biology
• Preferred scientific and clinical background in Oncology
• Proficient in using Phoenix WinNonlin, R, NONMEM, MATLAB or other pharmacokinetic and modeling software
• Strong documentation and organizational skills

Skills

• Pharmacokinetics (PK)
• Pharmacokinetic/Pharmacodynamic (PK/PD) modeling
• Population PK
• Modeling and simulation software (NONMEM, R, MATLAB, Phoenix WinNonlin)
• Regulatory documentation (IB, briefing books, NDA/BLA)

Education

• Ph.D. in a related field or Pharm.D./M.D. with relevant experience; M.S. with requisite experience may be considered