Senior/Executive Director, DMPK

Our client is a globally recognized partner to the pharmaceutical and biotechnology industries, providing scientific expertise and integrated drug development services across multiple therapeutic areas and stages of development. With a strong international presence and a collaborative, science-driven culture, they deliver broad impact and the opportunity to work on innovative programs.

About the role

Serve as the DMPK regulatory subject matter expert supporting global drug development and submission strategies. This flexible remote role offers international impact and broad industry exposure.

Responsibilities

• Provide guidance on DMPK content for IND, NDA, and other regulatory submissions across multiple regions.
• Advise project teams on study design, data interpretation, and regulatory expectations for drug development programs.
• Engage with health authorities on DMPK-related topics, including regulatory meetings and written responses.
• Advise cross-functional teams and contribute expertise to client discussions, proposals, and business growth initiatives.
• Mentor scientists and project teams on regulatory strategy, submission best practices, and emerging industry trends.
• Represent the organization through publications, conference presentations, and participation in industry groups.
• Monitor evolving regulatory requirements and help ensure development programs remain aligned with global standards.

Requirements

• PhD in a related field and 20+ years of Drug Metabolism and Pharmacokinetics experience within the biopharmaceutical industry.
• Strong track record supporting successful IND, NDA, or comparable regulatory submissions.
• Extensive experience interacting directly with global health authorities, including the FDA and EMA.
• Deep expertise in DMPK strategy, study design, data interpretation, and regulatory documentation.
• Ability to advise cross-functional teams and provide expertise to client-facing initiatives across global programs.

Pay

Base salary between $230,000 and $275,000 with bonus structure.

Benefits

• Comprehensive health and life insurance coverage.
• 401k plan.
• Remote work ability within the United States.