Director, Clinical Pharmacology

Role Summary

The Clinical Pharmacology Director leads strategic, scientific, and operational aspects at a program level. This role represents the department on strategic and cross-functional program teams and is responsible for developing clinical pharmacology plans; assists in departmental management through program reviews and collaborative decision-making; supervises asset leads and provides career development; co-leads cross-functional efforts and leads department initiatives.

Responsibilities

• Leverage clinical quantitative pharmacology skills to advance and support Vertex programs
• Guides metabolic, co-dosing and drug-drug interaction issues, collaborating closely with cross functional colleagues
• Co-leads or serves on cross-functional committees and/or contributes to or leads departmental initiatives
• Creates protocol concepts and guides protocol start-up including site initiations and investigator meetings
• Oversees and contributes to regulatory and safety documents
• Contributes to clinical pharmacology summary documents
• Guides PK analyses
• Performs PK/PD or exploratory analyses and guides PK/PD modeling or simulations as appropriate
• Provides management and career development to staff
• Assists in recruitment and hiring

Qualifications

• Ph.D. or Pharm D (or equivalent degree) in pharmacokinetics, pharmacometrics, clinical pharmacology or translational development and 10+ years of relevant post-doctoral employment experience, or
• Masters Degree (or equivalent degree) in pharmacokinetics, pharmacometrics, clinical pharmacology or translational development and 15+ years of relevant employment experience
• Typically requires 3 years of supervisory/management experience

Skills

• Subject matter expert in Clinical Pharmacology with experience in small molecules, biologics, or other modalities.
• Effective leadership skills to drive performance and provide career development opportunities to staff.
• Critical thinking skills, with keen scientific and development judgment.
• Broad experience in applying clinical pharmacology and dose optimization strategies for Phase II/III studies and regulatory submissions.
• Experience planning and executing Clinical Development plans for new clinical entities particularly as it applies to the discipline of Clinical Pharmacology.
• Experience conducting and supervising clinical studies such as drug-drug interaction, special population, thorough QT studies, or bioavailability.
• Experience conducting and supervising non-compartmental pharmacokinetic (PK) and PK/pharmacodynamic analyses.
• Hands on expertise in data analysis using Phoenix WinNonlin, R, and NONMEM.
• Experience with a range of clinical studies including first-in-human, proof-of-concept and registrational studies.
• Experience contributing to clinical and regulatory documents such as the Investigator's Brochure and contributing to regulatory correspondence.
• Experience working on teams and in a matrix environment.