Clinical Pharmacology Director

Vertex Inc.•Boston, MA

7d•$200,000 - $300,000•Remote

About The Position

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. Key Duties and Responsibilities: 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 Knowledge and Skills: 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 WinNonlin, 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 Education and Experience: 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

Requirements

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 WinNonlin, 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

Responsibilities

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