Job Description
This job is with Biogen, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. About This Role The Biomarkers and Systems Biology group is seeking a highly motivated Principal 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 Principal 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 with 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 PhD (preferred), or MS in Immunology, Cellular and Molecular Biology, or a related scientific field. PhD with 8+ years of relevant industry experience MS with 12+ years Hands‑on expertise with ligand‑binding assays (ELISA, MSD, Simoa), cell‑based assays, PK/PD biomarker methods, and ADA/NAb assay development. Advanced technical expertise in method development and validation in a regulated environment Experience supporting clinical trial sample analysis and data review. Strong understanding of global regulatory expectations (FDA, EMA, ICH, MHRA) for bioanalytical and immunogenicity submissions. Deep experience authoring Integrated Summary of Immunogenicity and other regulatory filing documents 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. Industry experience in biotech/pharma in a sen