Pioneering Medicines: Associate Director / Director, DMPK - Biologics

What if... We could harness the power of Flagship’s scientific platforms and create novel treatment options that benefit more patients, sooner?

Pioneering Medicines, an initiative of Flagship Pioneering, is building a world-class biopharmaceutical R&D capability focused on conceiving and developing life-changing treatments for patients by harnessing the power of Flagship's scientific platforms and applying those innovative approaches to serious diseases with unmet medical need. Unique to Pioneering Medicines’ approach is the opportunity to combine platforms to create truly novel and potentially transformative treatments. 

About Flagship Pioneering:

Flagship Pioneering is a biotechnology company that invents and builds platform companies that change the world. We bring together the greatest scientific minds with entrepreneurial company builders and assemble the capital to allow them to take courageous leaps. Those big leaps in human health and sustainability exponentially accelerate scientific progress in areas ranging from cancer detection and treatment to nature-positive agriculture.   

What sets Flagship apart is our ability to advance biotechnology by uniting life science innovation, company creation, and capital investment under one roof in a way that is largely without precedent. Our scientific founders, entrepreneurial leaders, and professional capital managers are each aligned around an institutionalized process that enables us to innovate and transform for the benefit of people and planet.   

Many of the companies Flagship has founded have addressed humanity’s most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture.  

Flagship has been recognized twice on FORTUNE’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies, and has been twice named to Fast Company’s annual list of the World’s Most Innovative Companies. 

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:

• D. 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.