Associate Director / Director DMPK Project Lead
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Pioneering MedicinesDrug Development
Cambridge, MA USA; this role can be remoteFull-TimeDirector
Salary148,000 - 236,500 USD per year
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Job Details
- Experience
- PhD with 8+ years, M.S. with 12+ years, or B.S. with 14+ years of relevant industry experience.
Requirements
- PhD. in pharmaceutical sciences, biochemistry, or related field with 8+ years of relevant industry experience; or M.S. with 12+ years; or B.S. with 14+ years.
- Proven track record representing DMPK in biologics discovery and/or development programs.
- Extensive hands-on experience with PK, BA, and immunogenicity assessment of biologics.
- Deep understanding of biologics development workflows.
- Working knowledge of regulatory expectations and experience contributing to submissions.
- Strong publication and/or patent record demonstrating scientific leadership.
- Demonstrated success in cross-functional team environments, with strong collaboration, communication, and presentation skills.
- Experience in managing CROs and external study oversight.
- Adaptable, detail-oriented, and able to manage multiple priorities in a fast-paced setting.
Responsibilities
- Serve as the DMPK representative on cross-functional discovery teams to guide PK, BA and immunogenicity strategies that support project decisions and milestones.
- Design and lead in vitro and in vivo PK/BA/Immunogenicity studies to characterize biologics properties and support candidate progression.
- Interpret study data, identify issues, and proactively troubleshoot technical challenges.
- Collaborate with internal and external stakeholders to plan and execute DMPK deliverables with high quality and efficiency.
- Collaborate with PK/PD modelers to establish PK/PD correlations and guide preclinical study design.
- Contribute to the selection of preclinical toxicology species and develop the toxicokinetic plan to support IND filing.
- Support human dose projections based on preclinical data to guide candidate selection.
- Author DMPK and BA sections of regulatory submissions (e.g., INDs, Investigator’s Brochures), and respond to regulatory queries.
- Contribute to the development of DMPK/BA functional processes and procedures focused on CRO interactions and organizational efficiency.
- Provide operational oversight for quality and performance of DMPK activities, including interactions with CROs and external project support.
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