Senior Scientist, Bioanalytical Sciences

Role Summary

Senior Scientist, Bioanalytical Sciences in the Biomarkers and Systems Biology group. Responsible for developing and executing bioanalytical strategies across multiple therapeutic programs, including development, optimization, and validation of bioanalytical assays for early and late-stage clinical studies. Lead immunogenicity strategy, provide oversight of CRO-executed assays, and contribute to global regulatory submissions. Based in Cambridge, MA with regular onsite presence; commuting distance or willingness to relocate may be required.

Responsibilities

• 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.

Qualifications

• Required: MS or BS in Immunology, Cellular and Molecular Biology, or a related scientific field.
• Required: MS with 6+ years of experience.
• Required: BS with 10+ years of experience.
• Required: Hands-on expertise with ligand-binding assays (ELISA, MSD, Simoa), cell-based assays, PK/PD biomarker methods, and ADA/NAb assay development.
• Required: Experience supporting clinical trial sample analysis and data review.
• Required: Strong understanding of global regulatory expectations (FDA, EMA, ICH, MHRA) for bioanalytical and immunogenicity submissions.
• Required: Proven experience managing CROs and external scientific partnerships.
• Required: Excellent technical writing, analytical interpretation, and communication skills.
• Required: Ability to work independently and effectively influence cross-functional teams in a matrixed environment.
• Required: Strong verbal and written communication skills with the ability to tailor presentations to diverse audiences.
• Required: Highly flexible, results-oriented, and comfortable operating in a fast-paced, dynamic environment.
• Required: Proficiency with ligand-binding and cell-based assay technologies across multiple platforms.
• Preferred: Experience authoring regulatory filing documents.
• Preferred: PhD in Immunology, Cellular and Molecular Biology, or a related scientific field with 4+ years of relevant industry experience.
• Preferred: Industry experience in biotech/pharma, ideally in drug discovery or translational research.
• Preferred: Advanced technical expertise in method development and validation in a regulatory environment.