Clinical Pharmacology Director
Vertex Pharmaceuticals
5 hours ago
Remote friendly (Boston, MA)
United States
$200,000 - $300,000 USD yearly
Clinical Research and Development
General Summary:
- Leads strategic, scientific, and operational clinical pharmacology activities at the program level.
- Represents the department on cross-functional program teams; develops clinical pharmacology plans; supports departmental management via program reviews and collaborative decision-making.
- Supervises asset leads, 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 partners.
- Co-lead or serve on cross-functional committees; contribute to or 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/simulations as appropriate.
- Provide mentorship; assist in recruitment and hiring.
Knowledge and Skills:
- Foundational clinical pharmacology knowledge across biologics, small molecules, and/or other modalities.
- Immunology/autoimmune therapeutic area experience (or relevant disease knowledge).
- Quantitative clinical pharmacology experience to derive decisions; data analysis expertise (Phoenix WinNonlin, R, NONMEM).
- Experience interacting with health authorities.
- Leadership, critical thinking, and strong scientific/development judgment.
- Experience planning/executing Clinical Development Plans; conducting/supervising DDI, special population, and bioavailability studies.
- Experience across first-in-human, proof-of-concept, and registrational studies.
- Experience contributing to clinical/regulatory documents (e.g., Investigator’s 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 plus 10+ years relevant post-doctoral experience; OR
- Master’s (or equivalent) plus 15+ years relevant experience.
- Typically requires 3 years of supervisory/management experience.
- Leads strategic, scientific, and operational clinical pharmacology activities at the program level.
- Represents the department on cross-functional program teams; develops clinical pharmacology plans; supports departmental management via program reviews and collaborative decision-making.
- Supervises asset leads, 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 partners.
- Co-lead or serve on cross-functional committees; contribute to or 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/simulations as appropriate.
- Provide mentorship; assist in recruitment and hiring.
Knowledge and Skills:
- Foundational clinical pharmacology knowledge across biologics, small molecules, and/or other modalities.
- Immunology/autoimmune therapeutic area experience (or relevant disease knowledge).
- Quantitative clinical pharmacology experience to derive decisions; data analysis expertise (Phoenix WinNonlin, R, NONMEM).
- Experience interacting with health authorities.
- Leadership, critical thinking, and strong scientific/development judgment.
- Experience planning/executing Clinical Development Plans; conducting/supervising DDI, special population, and bioavailability studies.
- Experience across first-in-human, proof-of-concept, and registrational studies.
- Experience contributing to clinical/regulatory documents (e.g., Investigator’s 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 plus 10+ years relevant post-doctoral experience; OR
- Master’s (or equivalent) plus 15+ years relevant experience.
- Typically requires 3 years of supervisory/management experience.