Pioneering Medicines: DMPK Project Lead

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. Compensation & Benefits The salary range for this role is $148,000 - $236,500. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Pioneering Medicines currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Pioneering Medicines's good faith estimate as of the date of publication and may be modified in the future. Privacy Notice for Applicants When you apply for a role at Flagship Pioneering or one of its portfolio companies, we collect and use personal information you provide (such as your name, contact details, work history, and application materials) to evaluate your application, communicate with you, and comply with legal obligations. Your application data is processed through Greenhouse, our applicant tracking system, and may also be reviewed using AI‑assisted screening tools. We do not sell your personal information. California residents have rights under the CCPA/CPRA including to know, delete, and opt out of the sharing of their personal information. If you are located in the EU or UK, we process your data under GDPR and you have rights to access, rectify, and erase your data. To exercise your rights or for questions, contact View email address on click.appcast.io. #J-18808-Ljbffr Flagship Pioneering