General Summary:
The Clinical Pharmacology Director leads strategic, scientific and operational aspects at a program level. Represents the department on cross-functional program teams; develops clinical pharmacology plans; supports 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.
Key Duties And 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/serve on cross-functional committees and contribute to/lead departmental initiatives.
- Create protocol concepts and guide protocol start-up (site initiations and investigator meetings).
- Oversee and contribute to regulatory and safety documents; contribute to clinical pharmacology summary documents.
- Guide PK analyses; perform PK/PD or exploratory analyses and guide PK/PD modeling or simulations.
- Provide mentorship; assist in recruitment and hiring.
Knowledge And Skills (Qualifications):
- Foundational knowledge in clinical pharmacology of biologics, small molecules, and/or other drug modalities.
- Immunology/autoimmune therapeutic area or relevant disease knowledge.
- Experience executing quantitative clinical pharmacology; hands-on data analysis using Phoenix WinNonlin, R, and NONMEM.
- Experience interacting with health authorities.
- Leadership, critical thinking, and scientific/development judgment.
- Experience planning/executing Clinical Development Plans.
- Experience conducting/supervising clinical studies (DDI, special populations, bioavailability) and first-in-human/PoC/registrational studies.
- Experience contributing to clinical/regulatory documents (e.g., Investigatorβs Brochure) and regulatory correspondence.
- Experience in matrix environments.
Education And Experience:
- Ph.D. or Pharm D (or equivalent) in pharmacokinetics, pharmacometrics, clinical pharmacology or translational development with 10+ years relevant post-doctoral experience; or
- Masters (or equivalent) with 15+ years relevant experience.
- Typically 3 years supervisory/management experience.
Application Instructions:
- Contact Talent Acquisition at ApplicationAssistance@vrtx.com for accommodation requests related to hiring process or essential functions.