Senior Scientist, Bioanalytical Sciences

About This Role

The Biomarkers and Systems Biology group is seeking a highly motivated Senior Scientist to join a dynamic team responsible for developing and executing bioanalytical strategies across multiple therapeutic programs. This role is central to the development, optimization, and validation of bioanalytical assays supporting early and late-stage clinical studies. The Senior Scientist will lead immunogenicity strategy, provide scientific oversight of CRO-executed assays, and contribute to global regulatory submissions.

The ideal candidate has deep expertise in pharmacokinetic and immunogenicity bioanalysis, with additional experience in biomarker methods. Hands-on assay development experience across multiple platforms and a strong understanding of regulatory expectations are essential. The role requires scientific rigor, sound judgment, and the ability to operate effectively in a fast-paced biotech environment.

What You'll Do

• Lead development, optimization, and validation of PK, biomarker, ADA, NAb, and other immunogenicity-related assays in alignment with FDA, EMA, and ICH guidelines.
• Develop and execute immunogenicity strategy, including risk assessments aligned with modality, target biology, and clinical stage.
• Oversee outsourced biomarker, immunogenicity, and bioanalytical assays at CROs, providing scientific direction, troubleshooting, protocol guidance, and data review.
• Analyze and interpret PK, PD, safety, biomarker, and immunogenicity data in close collaboration with Clinical Development, Clinical Pharmacology, Translational Medicine, Safety, and Regulatory Affairs.
• Ensure data integrity, traceability, and scientific clarity across all bioanalytical and regulatory deliverables.
• Evaluate, implement, and provide expertise across analytical platforms (e.g., ELISA, MSD, etc.).
• Prepare regulatory responses, briefing packages, and support interactions with health authorities.
• Serve as the Bioanalytical Lead on study and program teams, defining strategy and ensuring alignment with development objectives.
• Deliver scientific presentations internally and externally and contribute to manuscripts and publications.
• Promote best practices in assay development, CRO oversight, and scientific rigor.

Who You Are

• You are a scientifically rigorous bioanalytical expert who thrives on developing, validating, and troubleshooting complex PK, immunogenicity, and biomarker assays to support clinical programs.
• You are motivated by driving high-quality, clinically relevant bioanalysis and immunogenicity strategy, and you excel at interpreting data in a cross-functional, fast-paced environment.
• You enjoy partnering with internal teams and CROs, providing clear scientific direction, and ensuring assays meet regulatory and program needs.
• You communicate clearly, work independently, and bring strong judgment to problem-solving, regulatory interactions, and strategic decision-making.
• This position is based in Cambridge, MA and requires regular onsite presence; candidates must be within commuting distance or willing to relocate.

Required Skills

• MS, or BS in Immunology, Cellular and Molecular Biology, or a related scientific field.
• MS with 6+ years
• BS with 10+ years
• Hands-on expertise with ligand-binding assays (ELISA, MSD, Simoa), cell-based assays, PK/PD biomarker methods, and ADA/NAb assay development.
• Experience supporting clinical trial sample analysis and data review.
• Strong understanding of global regulatory expectations (FDA, EMA, ICH, MHRA) for bioanalytical and immunogenicity submissions.
• Proven experience managing CROs and external scientific partnerships.
• Excellent technical writing, analytical interpretation, and communication skills.
• Ability to work independently and effectively influence cross-functional teams in a matrixed environment.
• Strong verbal and written communication skills with the ability to tailor presentations to diverse audiences.
• Highly flexible, results-oriented, and comfortable operating in a fast-paced, dynamic environment.
• Proficiency with ligand-binding and cell-based assay technologies across multiple platforms.
• Experience authoring regulatory filing documents is a plus.

Preferred Skills

• PhD in Immunology,…