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Cambridge, Massachusetts, United States
Hybrid
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
· PhD (preferred), MS, or BS in Immunology, Cellular and Molecular Biology, or a related scientific field.
· PhD with 4+ years of relevant industry experience
· 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
· Industry experience in biotech/pharma, ideally in drug discovery or translational research.
· Advanced technical expertise in method development and validation in a regulatory environment.
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.