Director, Clinical Pharmacology

About the role

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

Responsibilities

• Guides metabolic, co-dosing, and drug-drug interaction issues in collaboration with cross-functional colleagues.
• Co-leads or serves on cross-functional committees and 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 pharmacokinetic (PK) analyses.
• Performs PK/PD or exploratory analyses and guides PK/PD modeling or simulations as appropriate.
• Provides management and career development to staff, including recruitment and hiring.
• May have financial accountabilities and human resource responsibilities for assigned staff.

Requirements

• Knowledge expert in Clinical Pharmacology.
• Effective leadership skills to drive performance and provide career development opportunities.
• Critical thinking skills with keen scientific and development judgment.
• Experience planning and executing Clinical Development Plans for new clinical entities, particularly in Clinical Pharmacology.
• Experience conducting and supervising clinical studies such as drug-drug interaction, special population, or bioavailability studies.
• Experience conducting and supervising non-compartmental pharmacokinetic (PK) and PK/pharmacodynamic analyses.
• 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 regulatory correspondence.
• Experience working on teams and in a matrix environment.

Qualifications

Required education and experience:

• 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
• Master’s 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.

Pay

Pay range: $200,000 - $300,000. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary will be based on skills, competencies, experience, and other job-related factors permitted by law.

Benefits

• Inclusive market-leading medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in the Summer and Winter.
• Educational assistance programs, including student loan repayment.
• Generous commuting subsidy.
• Matching charitable donations.
• 401(k) retirement plan.

Schedule

This is a Hybrid-Eligible role, allowing you to choose:

• Hybrid: Work remotely up to two days per week, or
• On-Site: Work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.