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Job Description

The Clinical Pharmacologist Associate Director manages scientific and operational aspects at a study level and assists development at a program level. He/she may represent the department on cross-functional study teams and contribute toward clinical pharmacology plans. The candidate will have expertise in clinical pharmacology concepts and applications, particularly with biologics. He/She will have the ability to effectively communicate, both in verbal and written form.

General Summary:

Clinical Pharmacology Associate Director manages scientific and operational aspects at a study level and assists development at a program level. He/she may represent the department on cross-functional study teams and contribute toward clinical pharmacology plans. The candidate will have expertise in clinical pharmacology concepts and applications, particularly with biologics. He/She will have the ability to effectively communicate, both in verbal and written form.

Key Duties and Responsibilities:

• Representation for clinical pharmacology on at a program level and oversee all study-related activities

• Contribute to clinical pharmacology plans including drug-drug interaction, special population and safety studies

• Generate hypothesis and provide strategy for clinical pharmacology study types e.g., metabolic, drug-drug interaction issues, special populations collaborating closely with cross functional colleagues

• Create protocol concepts and guide protocol start-up including site initiations

• Participate in study teams, oversee study progression including protocol conduct, data analyses, internal decision points and final reporting

• Lead management of studies outsourced to contract research organization

• Co-lead or serve on cross-functional committees and/or contribute to or lead departmental initiatives

• Collaborate with other functions to guide program deliverables

• Contribute to clinical pharmacology summary documents

• Perform advanced/complex PK and PK/PD or exploratory analyses or guide such analyses as appropriate

• Guide and/or assist with PK/PD modeling or simulations

• Prepare technical reports including clinical study reports

• Maintain a high standard for good clinical practice, compliance and ethics

• Lead and contribute toward publications and abstracts

Knowledge and Skills:

Education and Experience:

• Minimum education and experience requirements: Ph.D., MD/ PhD or PharmD in a related field, with minimum of 6 years of industry or regulatory agency experience; M.S. in a related field with minimum of 8 years of industry or regulatory agency experience

• Clinical pharmacology experiences with biologics

• Critical thinking skills, with keen scientific judgment

• Supervise or conduct clinical studies such as drug-drug interaction, special population or bioavailability

• Provide support for other studies such as first-in-human, proof-of-concept or registrational studies

• Supervise or conduct non-compartmental pharmacokinetic (PK) and PK/pharmacodynamic analyses

• Provide key guidance on clinical and regulatory documents such as the Investigator’s Brochure and contributing to regulatory correspondence

• Ensure close collaboration of Clinical Pharmacology with Modeling and Simulation

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.

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