Senior/Executive Director, Regulatory DMPK
Full-time
- Lead global regulatory DMPK strategy at a top CRO with broad industry exposure.
- Flexible remote role with international impact.
About Our Client
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, our client delivers broad impact and the opportunity to work on innovative programs.Job Description
- Serve as the DMPK regulatory subject matter expert supporting global drug development and submission strategies.
- 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.
The Successful Applicant
A successful Senior/Executive Director, DMPK should have:
- PhD in a related field and 20+ years of Drug Metabolism and Pharmacokinetics experience within the biopharmaceutical industry.
- A 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.
- An ability to advise cross-functional teams and provide expertise to client-facing initiatives across global programs.
What’s on Offer
- Base salary between $230,000 and $275,000 with bonus structure.
- Comprehensive health and life insurance coverage, and a 401k plan.
- Remote work ability within the United States.
Contact
Todd Jamison
Quote job ref
JN-082026-7076128
Vacancy posted 19 days ago
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