DMPK Project Lead

Responsibilities

• Serve as the DMPK representative on cross-functional discovery teams to guide PK, BA, and immunogenicity strategies.
• 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 PK/PD modelers to establish correlations and guide preclinical study design.
• Contribute to the selection of preclinical toxicology species and develop toxicokinetic plans for IND filing.
• Support human dose projections based on preclinical data to guide candidate selection.
• Author DMPK and BA sections of regulatory submissions, including INDs and Investigator’s Brochures.
• Provide operational oversight for DMPK activities, including the selection, qualification, and management of CROs and external vendors.

Requirements

• PhD in pharmaceutical sciences, biochemistry, or a related field with 8+ years of relevant industry experience (or equivalent experience via M.S. or B.S.).
• 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.
• Experience in managing CROs and providing external study oversight.
• Working knowledge of regulatory expectations and experience contributing to regulatory submissions.

Preferred Qualifications

• Familiarity with small molecules or novel therapeutic modalities.
• Strong publication or patent record demonstrating scientific leadership.
• Exceptional communication and presentation skills for cross-functional collaboration.

Benefits

• Healthcare coverage.
• Annual incentive program.
• Retirement benefits.
• A broad range of other company benefits.

About the Company

Pioneering Medicines is Flagship Pioneering’s in-house drug development unit. We are dedicated to conceiving and developing a broad portfolio of life-changing treatments built from Flagship’s innovative scientific platforms. We work to accelerate therapeutic innovation by bringing together expertise in drug discovery, development, and production.