Job Description

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 Investigators 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:

$200000 - $300000

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors including skills competencies experience and other job-related factors permitted by law.

At Vertex our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career financial family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter) educational assistance programs including student loan repayment a generous commuting subsidy matching charitable donations 401(k) and so much more.

Flex Designation:

Remote-Eligible

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 youre 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 Vertexs 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 persons 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

Required Experience:

Director

Job Tags

Full time, Work experience placement, Summer work, Work at office, Remote work, Flexible hours, 2 days per week

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