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.

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

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Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

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Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com