Clinical Pharmacology Director

Vertex Pharmaceuticals Incorporated; Boston (MA); On-site; USD 200,000 - 300,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Generous paid time off

Educational assistance programs

Job summary

A leading biotechnology company in Boston seeks a Clinical Pharmacology Director to lead strategic and operational aspects at the program level. Key responsibilities include developing clinical pharmacology plans, overseeing regulatory documents, and mentoring staff. Ideal candidates will have a Ph.D. or Pharm D, extensive experience in clinical pharmacology, particularly in immunology, and strong leadership skills. The position offers remote eligibility and a competitive salary range between $200,000 and $300,000.

Qualifications

• 10+ years of relevant post-doctoral employment experience.
• Typically requires 3 years of supervisory/management experience.
• Experience in executing quantitative clinical pharmacology.

Responsibilities

• Lead strategic and operational aspects at a program level.
• Responsible for the application of clinical quantitative pharmacology.
• Oversee and contribute to regulatory and safety documents.

Skills

Clinical pharmacology of biologics

Immunology knowledge

Data analysis using Phoenix WinNonlin

Leadership skills

Critical thinking

Education

Ph.D. or Pharm D in pharmacokinetics

Master's Degree in pharmacokinetics

Tools

Phoenix WinNonlin

R

NONMEM

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 in the 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 interacting with health authorities.
• Effective leadership skills to drive performance and provide career development opportunities to staff.
• Critical thinking skills, with keen scientific and developmental 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 studies.
• 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
• Master's 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.

Pay Range

$200,000 - $300,000

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

• Remote: work remotely five days per week and come into the office on occasion - you're always welcome on‑site.
• Hybrid: work remotely up to two days per week.
• On‑Site: work five days per week on‑site with ad hoc flexibility.

Equal Employment Opportunity Statement

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 [e-mail].