Director, Clinical Pharmacology

Vertex Inc.; Boston (MA); Hybrid; USD 200,000 - 300,000; Full time

Benefits offered by this job

Equity awards

Annual bonus

Healthcare benefits

Job summary

Vertex is seeking a Director, Clinical Pharmacology to lead strategic, scientific and operational aspects at the program level. You will supervise asset leads, guide PK analyses, and oversee regulatory documents while supporting department initiatives.

You will drive development plans for clinical entities, mentor staff, participate in recruitment, and contribute to cross-functional program teams in a hybrid on-site environment with eligibility for flexible work arrangements.

Qualifications

• Ph.D. or PharmD in pharmacology or translational development with 10+ years of relevant post-doctoral employment experience
• Master’s degree in pharmacokinetics/pharmacometrics or translational development with 15+ years of experience
• Typically requires 3 years of supervisory/management experience

Responsibilities

• Guide metabolic, co-dosing and DDI issues with cross-functional colleagues
• Co-lead cross-functional committees and department initiatives
• Create protocol concepts and guide start-up including site initiation and investigator meetings
• Oversee regulatory and safety documents and contribute to PK/PD modeling
• Perform PK/PD analyses and simulations as appropriate
• Provide leadership and career development for staff
• Assist in recruitment and hiring
• Manage staff with HR responsibilities where applicable

Skills

Clinical Pharmacology expertise

Leadership

Strategic thinking

Cross-functional collaboration

PK/PD analyses

Regulatory documentation

People management

Recruitment

Education

PhD or PharmD in pharmacology/related

MS in pharmacokinetics/related

Job description

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:
1. Hybrid : work remotely up to two days per week; or select
2. 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.

#LI-Hybrid

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]