Remote DMPK Project Leader – Biologics & Immunogenicity

Flagship Pioneering; Cambridge (MA); On-site; USD 148,000 - 236,500; Full time

Benefits offered by this job

Healthcare coverage

Annual incentive program

Retirement benefits

Broad range of benefits

Job summary

Flagship Pioneering seeks an accomplished DMPK project representative to guide PK, BA, and immunogenicity across a biologics portfolio. This leadership role collaborates with discovery and development teams to optimize candidate progression and regulatory readiness.

The ideal candidate brings deep DMPK expertise, strong data interpretation, and a proven ability to influence cross-functional strategies in a fast-paced environment. Remote or Cambridge, MA site option offered.

Qualifications

• PhD in pharmaceutical sciences, biochemistry, or related field with 8+ years of relevant industry experience; or MS with 12+ years; or BS 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.

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 PK/BA/Immunogenicity in vitro and in vivo 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 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) 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.

Skills

DMPK leadership

PK/BA/Immunogenicity

Biologics development

Regulatory submissions

Scientific leadership

Cross-functional collaboration

CRO management

Project management

Education

PhD in pharmaceutical sciences/biochemistry or related field

MS in related field

BS in related field

Job description

Flagship Pioneering seeks an accomplished DMPK project representative to guide PK, BA, and immunogenicity across a biologics portfolio. This leadership role collaborates with discovery and development teams to optimize candidate progression and regulatory readiness.

The ideal candidate brings deep DMPK expertise, strong data interpretation, and a proven ability to influence cross-functional strategies in a fast-paced environment. Remote or Cambridge, MA site option offered.