Pioneering Medicines: Associate Director / Director DMPK Project Lead

About the role

We are seeking a highly experienced and dedicated DMPK project leader to join our innovative team at Flagship Pioneering in Cambridge, MA. This position plays a critical role in providing scientific and strategic guidance across our biologics portfolio, which encompasses various therapeutic modalities. The ideal candidate will possess a strong background in DMPK, bioanalysis, and immunogenicity science, and will work closely with multidisciplinary teams to drive forward our drug development efforts. You will be responsible for designing, executing, and analyzing DMPK studies, collaborating with internal teams and external partners, and contributing to regulatory submissions. This role offers an exciting opportunity to influence the development of novel biologics and to work within a dynamic, fast-paced environment committed to pioneering medicines.

Key facts

What you'll do

• Serve as the primary DMPK representative on cross-functional project teams, providing expert guidance on pharmacokinetics, bioanalysis, and immunogenicity strategies to inform key project decisions.
• Design, plan, and oversee both in vitro and in vivo DMPK studies to evaluate the properties of biologics, including absorption, distribution, metabolism, and excretion, to facilitate candidate selection and progression.
• Analyze complex study data, identify technical or scientific challenges, and develop innovative solutions to address issues related to DMPK and bioanalysis.
• Collaborate closely with internal teams, including discovery, preclinical, clinical, and regulatory groups, as well as external partners such as contract research organizations (CROs), to ensure high-quality and timely execution of DMPK activities.
• Work with pharmacokinetic/pharmacodynamic (PK/PD) modelers to establish correlations between preclinical data and clinical outcomes, guiding the design of subsequent studies and dose selection.
• Assist in the selection of appropriate preclinical toxicology species and develop comprehensive plans for toxicokinetic and toxicology studies to support Investigational New Drug (IND) applications.
• Provide projections for human dosing based on preclinical pharmacokinetic data, supporting the evaluation of candidate compounds for clinical development.
• Prepare and review DMPK and bioanalysis sections of regulatory documents, including INDs, briefing packages, and other submissions, and address any regulatory inquiries related to DMPK data.
• Develop, implement, and optimize DMPK and bioanalysis processes, with a focus on interactions with CROs, to improve efficiency, reproducibility, and data quality.
• Oversee the performance and quality of DMPK activities conducted by CROs and external vendors, ensuring compliance with regulatory standards and project timelines.
• Participate in the selection, qualification, and management of CROs and external vendors, establishing clear expectations and performance metrics.
• Collaborate with internal stakeholders and companies within the Flagship ecosystem to align DMPK strategies with overall project goals and corporate objectives.
• Keep abreast of the latest scientific developments, regulatory requirements, and industry best practices related to DMPK, bioanalysis, and biologics development.

Requirements

• Ph.D. in pharmaceutical sciences, biochemistry, or a related field with a minimum of 8 years of relevant industry experience; or an M.S. with at least 12 years; or a B.S. with 14 years of experience in DMPK or related disciplines.
• Proven track record of leading DMPK efforts in biologics discovery and development programs, with demonstrated experience in designing and interpreting pharmacokinetic and bioanalytical studies.
• Extensive hands-on experience with pharmacokinetics, bioanalysis, and immunogenicity assessment for biologics, including assay development, validation, and data analysis.
• Strong understanding of biologics development workflows, including early discovery through clinical phases, and familiarity with regulatory expectations for DMPK data.
• Experience contributing to regulatory submissions such as INDs, BLAs, or NDAs, and addressing regulatory questions related to DMPK.
• A solid publication record or patents that demonstrate scientific leadership and expertise in DMPK sciences.
• Excellent collaboration, communication, and presentation skills, with the ability to work effectively across multidisciplinary teams and external partners.
• Experience managing CROs and external vendors, including overseeing study execution, quality control, and timelines.
• Ability to handle multiple priorities in a fast-paced environment, demonstrating flexibility, attention to detail, and problem-solving skills.
• Strong organizational skills, with the ability to develop and implement project plans and timelines.

Nice to have

• Experience working with small molecules or other therapeutic modalities beyond biologics.
• Familiarity with advanced modeling and simulation techniques, including PK/PD modeling and physiologically based pharmacokinetic (PBPK) modeling.
• Knowledge of immunogenicity assessment strategies and technologies.
• Understanding of ITAR regulations and experience working with international regulatory agencies.
• Experience working within a biotech or pharmaceutical startup environment, particularly within innovative or early-stage companies.
• Fluency in additional languages or experience working in global teams.

Skills & tools

• Expertise in DMPK, bioanalysis, and immunogenicity sciences.
• Familiarity with regulatory submission processes and requirements, including INDs and other filings.
• Strong analytical skills, with proficiency in data interpretation and problem-solving.
• Excellent written and verbal communication skills, capable of preparing clear reports and presenting complex data to diverse audiences.
• Ability to develop and optimize bioanalytical assays, including ligand-binding and cell-based assays.
• Experience with laboratory information management systems (LIMS) and data analysis software.
• Knowledge of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards.

Practical notes

The salary for this position ranges from $148,000 to $236,500, depending on qualifications, skills, and experience. Flagship Pioneering offers a comprehensive benefits package, including healthcare coverage, an annual incentive program, retirement plans, and other perks. The company values diversity and inclusion and encourages applicants from all backgrounds to apply. Please note that salary ranges and benefits may be subject to change in the future. This role is based on-site in Cambridge, MA, and requires working at the office location. Candidates should be prepared to work on-site and collaborate closely with teams in person.