Section Head of Clinical Pharmacology & Pharmacometrics

Description

• Leads and manages high profile clinical pharmacology activities including training, CDP and study designs with R&D across drug modalities and Biogen disease areas
• Leads clinical pharmacology efforts in early and late stage (e.g., study design, protocol concepts/protocols preparation, clinical phase oversight, data analysis, and reporting) within assigned programs to yield high value PK/PD insight for critical decisions. Analyzes results, interprets, and recommends action based on study results.
• Ability to represent clinical pharmacology function at governance (DPAC, RDGC, TRC) and external advisory boards
• Provides extensive regulatory strategy expertise for drug filings and is responsible for Clinical Pharmacology sections of regulatory documents. Maintains cutting edge knowledge of best regulatory practices, Clinical Pharmacology technology and drug development precedent.
• Engages in cross-functional activities providing Clinical Pharmacology input and provides a source of Clinical Pharmacology expertise and advice to other functions across the Company. Participates in and provides Clinical Pharmacology perspective to cross-functional committees and activities.
• Maintains extensive scientific awareness and presence in Clinical Pharmacology, publishes multiple manuscripts and posters, presents at Scientific Conferences and other scientific forums. Engages with consultants and advisors in the field, as well as the scientific community at large.
• Manages and/or mentors staff within the function and matrix leadership across projects. Develops expertise in highly specialized and/or novel aspects of Clinical Pharmacology and serves as a reference source in these for his peers.

Qualifications

• Ph.D., M.D./Ph.D., or Pharm.D. in Clinical Pharmacology, pharmacokinetics, or a related field
• 15+ years of direct industry experience in Clinical Pharmacology
• Demonstrated experience in leading teams and/or managing professional staff
• International recognized expert in Quantitative Clinical Pharmacology
• Solid experience in developing Clinical Pharmacology strategy, designing/implementing Clinical Pharmacology studies
• Strong knowledge of the drug development process and overall familiarity with the regulatory process. Direct experience in preparing regulatory submissions and responding to health authority questions.
• Extensive record of publications, presentations, invited lectures, and other scientific activities
• Active knowledge of advanced methods for Quantitative Pharmacology and PMx analyses
• Experience with use of PK/PD software packages such as -Phoenix WinNonlin, SimCYP, NONMEM, Monolix, R, Adapt, MATLAB, SAS