Director, Clinical Pharmacology

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

Benefits offered by this job

Total Rewards benefits

Job summary

Vertex Pharmaceuticals is seeking a Director of Clinical Pharmacology in the Boston area to lead strategic, scientific and operational aspects at the program level. This role represents the department on cross-functional program teams and will be responsible for developing clinical pharmacology plans, assisting in departmental management, supervising asset leads, and driving department initiatives.

The role includes leadership of PK/PD analyses, oversight of regulatory documents, and recruitment

Qualifications

• 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.

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.

Skills

Clinical Pharmacology

Leadership

Critical thinking

Clinical Development Plans

Clinical studies

PK/PD analyses

Diversity of clinical studies

Regulatory documents

Team work

Education

Ph.D. or PharmD (or equivalent) in pharmacokinetics, pharmacometrics, clinical pharmacology or translational development and 10+ years of relevant post-doctoral employment experience, or

Masters Degree (or equivalent) in pharmacokinetics, pharmacometrics, clinical pharmacology or translational development and 15+ years of relevant employment experience

Typically requires 3 years of supervisory/management experience

Job description

General Summary

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.

Job Description

General Summary

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.

Key Duties And 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

Knowledge And Skills

• 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

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

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

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status

In this Hybrid-Eligible role, you can choose to be designated as:

• Hybrid: work remotely up to two days per week; or select
• 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.

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 [e-mail]