Pioneering Medicines Associate Director Director DMPK Project Lead

What if...We could harness the power of Flagships scientific platforms and create novel treatment options that benefit more patients sooner

About Pioneering Medicines:

Pioneering Medicines Flagship Pioneerings in-house drug development unit is dedicated to conceiving and developing a broad portfolio of life-changing treatments for patients built from Flagships innovative platforms. Harnessing the drug development expertise of its team together with the power of Flagships multiple scientific platforms Pioneering Medicines explores and identifies new product concepts which are then advanced jointly with Flagships bioplatform companies. Within Flagships Innovation Supply Chain partnerships Pioneering Medicines works with external collaborators to apply its unique approach to partners R&D priorities. These partnerships are highly co-creative strategic alliances that accelerate therapeutic innovation by bringing together partners spanning the full spectrum of drug discovery development and production.

This role can be remote or at our Cambridge MA site. If over 30 miles from our Cambridge site a travel cadence will be set at time of offer (about monthly).

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 Investigators 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:

• 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.
  
  

About Flagship

Flagship Pioneering is a scientific innovation engine that invents and builds 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 in human health sustainability and beyond.

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 islargely withoutprecedent. Our team of scientists entrepreneurial leaders and professional capital managersare eachaligned around an institutionalized process that enables us to innovate and create breakthroughs for the benefit of people andplanet. Many of the companies Flagship has founded have addressed humanitys 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 FORTUNEs 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 named four times to Fast Companys annual list of the Worlds Most Innovative Companies.

At Flagship we recognize there is no perfect candidate. If you have some of the experience listed above but not all please apply anyway. Experience comes in manyformsskills are transferable and passion goes a long way. We are dedicated to building diverse and inclusive teams and look forward to learning more about your unique background.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively FSP) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneerings internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP and FSP will not owe any referral or other fees with respect thereto.

The salary range for this role is $148000 - $236500. Compensation for the role will depend on a number of factors including a candidates 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 Mediciness good faith estimate as of the date of publication and may be modified in the future.

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