Position Summary:We are seeking a highly motivated and experienced DMPK project representative to join our growing team. This leadership role will provide scientific and strategic DMPK guidance across our biologics portfolio, supporting a wide range of therapeutic modalities including monoclonal antibodies, bispecifics, fusion proteins, and innovative targeted-delivery platforms.
The ideal candidate brings deep expertise in DMPK, bioanalysis (BA), and immunogenicity science, with a proven ability to influence discovery and development strategies for biologics. You will collaborate closely with multi-disciplinary teams to optimize candidate selection, design and execute preclinical studies, and ensure regulatory readiness. This is a high-impact role requiring strong analytical thinking, scientific rigor, and exceptional communication skills.
Key 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.
- Contribute to the selection and qualification of CROs and external vendors.
- Engage closely with internal stakeholders and companies within the Flagship ecosystem.
Qualifications:- 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; familiarity with small molecules or novel modalities is a plus.
- 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.
