Director, Clinical Pharmacology

Vertex Inc.•Boston, MA

19h•$200,000 - $300,000•Hybrid

About The Position

The Director, Clinical Pharmacology 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.

Requirements

Knowledge expert in Clinical Pharmacology
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 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 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

Responsibilities

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 management and career development to staff
Assists in recruitment and hiring
As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff