Clinical Pharmacology Director

Job Description

General

Summary:

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 and will be responsible for the development of clinical pharmacology plans; assists in departmental management through program reviews and collaborative decision-making; supervises asset leads, provides career development; routinely co-leads cross-functional efforts and leads department initiatives.

• Responsible for the application of clinical quantitative pharmacology strategy to support the immunology portfolio.
• 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 mentorship to staff.
• Assists in recruitment and hiring.

• Strong foundational knowledge in the clinical pharmacology of biologics, small molecules, and/or other drug modalities.
• Working experience of Immunology and Autoimmune diseases therapeutic area or relevant disease knowledge.
• Experience in executing quantitative clinical pharmacology to derive decisions. Hands‑on expertise in data analysis using industry-standard tools such as Phoenix Win Nonlin, R, and NONMEM.
• Experience of interaction with healthy authorities.
• Effective leadership skills to drive performance and provide career development opportunities to staff.
• Critical thinking skills, with keen scientific and development judgment.
• 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 or bioavailability.
• 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.

• 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.

$200,000 - $300,000

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. 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 pay will be based on a number of factors, including skills, competencies, experience, and other job‑related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market‑leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week‑long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Remote-Eligible

In this Remote-Eligible role, you can…