Head of Bioanalysis

Work Location: Suffolk County, Massachusetts

Summary:

Seeking an experienced scientist to lead bioanalysis activities supporting the advancement of targeted genetic medicines from discovery through clinical development. This role provides scientific, operational, and strategic leadership for research-grade and regulated bioanalysis, including oversight of external partnerships and delivery of high-quality PK, PD, biomarker, and immunogenicity data for global regulatory submissions.

Responsibilities:

• Develop and implement bioanalytical strategies for preclinical and clinical programs, ensuring alignment with overall development goals.
• Lead the design, validation, and execution of bioanalytical methods for PK, PD, biomarker, and immunogenicity endpoints using advanced analytical technologies.
• Serve as the primary scientific interface for external laboratory partners, overseeing study plans, contracts, and data transfer agreements.
• Ensure timely delivery of high-quality, compliant data by managing outsourced bioanalytical activities and maintaining GLP, GCP, or CLIA standards.
• Collaborate with cross-functional teams to support study design, regulatory strategy, and seamless assay transfer from discovery through clinical development.
• Mentor and develop analytical scientists, promoting best practices in assay lifecycle management and technical excellence.
• Contribute to regulatory submissions, including IND, CTA, NDA, and MAA, by authoring and reviewing bioanalytical reports and documentation.
• Drive strategic planning and troubleshoot technical challenges to ensure scientific rigor and alignment with pipeline priorities.

Qualifications:

• Ph.D. in Analytical Chemistry, Biochemistry, Molecular Biology, or related discipline with 10+ years of industry experience; or MS/BS with equivalent progressive experience.
• Demonstrated leadership experience managing scientists and/or external laboratory partners.
• Extensive hands-on experience with ligand-binding assays, PCR, LC-MS/MS, and/or cell-based bioanalytical methods.
• Strong background in regulated bioanalysis (GLP, GCLP, CLIA).
• Experience supporting bioanalysis for nucleic acid therapeutics, biologics, or small molecules.
• Proven experience authoring and reviewing bioanalytical reports and regulatory documentation.
• Deep understanding of drug development and bioanalytical strategy for preclinical and clinical programs.
• Excellent communication, stakeholder management, strategic thinking, and problem-solving skills; ability to manage multiple programs in parallel.

Published Category: Discovery Research & Preclinical