Clinical Pharmacology Director

About the Role

The Clinical Pharmacology Director leads strategic, scientific, and operational aspects at a program level. This role represents the department on strategic and operational 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 Director routinely co-leads cross-functional efforts and leads department initiatives.

Responsibilities

• Apply clinical quantitative pharmacology strategy to support the immunology portfolio.
• Guide metabolic, co-dosing, and drug-drug interaction issues in collaboration with cross-functional colleagues.
• Co-lead or serve on cross-functional committees and contribute to or lead departmental initiatives.
• Create protocol concepts and guide protocol start-up, including site initiations and investigator meetings.
• Oversee and contribute to regulatory and safety documents.
• Contribute to clinical pharmacology summary documents.
• Guide PK analyses and perform PK/PD or exploratory analyses; guide PK/PD modeling or simulations as appropriate.
• Provide mentorship to staff and assist in recruitment and hiring.

Requirements

• Strong foundational knowledge in the clinical pharmacology of biologics, small molecules, and/or other drug modalities.
• Working experience in the Immunology and Autoimmune diseases therapeutic area or relevant disease knowledge.
• Experience executing quantitative clinical pharmacology to derive decisions.
• Hands-on expertise in data analysis using industry-standard tools such as Phoenix WinNonlin, R, and NONMEM.
• Experience interacting with health authorities.
• 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 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

• 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.

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 and additional financial benefits.

Schedule

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

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

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