Director, Clinical Pharmacology

Job Description

The Director of Clinical Pharmacology serves as the clinical pharmacology lead on several early clinical development or program teams providing strategic leadership and execution of clinical development plans that include characterization and prediction of the pharmacokinetics, pharmacodynamics and drug metabolism (PPDM) of the drug candidate in selected preclinical and all clinical areas. This person also provides rationale for dose regimen selection, safety margin assessment and identification of circumstances where dose adjustment or patient selection/stratification should be considered. The Director also serves as a manager/mentor to less experienced staff and as a Clinical Pharmacology resource within the function and across the company.

• Drives the development and execution of the Clinical Pharmacology Strategy and Plan of several clinical development and/or program teams. Provides key components of the Early Development Plan, advises teams on Clinical Pharmacology Strategy and science and provides input to line management.
• Works with clinical development and/or program teams to achieve program goals and provide deliverables in approved timeframes
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• Leads clinical pharmacology efforts (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.
• 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 junior staff within the function. Develops expertise in highly specialized and/or novel aspects of Clinical Pharmacology and serves as a reference source in these for his peers.

Qualifications

• Excellent knowledge of the principles of Clinical Pharmacology and PPDM
• Demonstrates strong team work in a multidisciplinary environment
• Ability to manage and mentor more junior scientists
• 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

• Ph.D., M.D./Ph.D., or Pharm.D. in Clinical Pharmacology, pharmacokinetics, or a related field
• 8+ years of direct industry experience in Clinical Pharmacology & PPDM.
• Experience in leading teams and/or managing professional staff.
• Solid experience in developing Clinical Pharmacology strategy, designing/implementing Clinical Pharmacology studies

Additional Information

All your information will be kept confidential according to EEO guidelines.