Sr. Scientist, Bioanalytical Biomarker Sciences

We are seeking a highly motivated and skilled Senior Scientist with expertise in bioanalytical and biomarker assays to join our growing Translational Sciences team. This role will report to the Head of Bioanalytical and Biomarker Sciences (BBS) and will represent the BBS function across discovery and early development programs.

The successful candidate will bring strong experience in bioanalytical/biomarker assay development, qualification, validation, and will provide critical analytical support to enable data-driven decision-making from drug candidate selection through clinical development. This individual will work closely with internal research teams, cross-functional program partners, and external CROs to support both discovery- and development-stage programs.

The ideal candidate will have hands-on experience with a variety of assays including ligand binding assays, ideally, in a regulated environment. He/She will play a key role in advancing analytical method development, overseeing PK/PD sample analysis, interpreting complex data, and directing CRO activities as needed to ensure high-quality, decision-enabling bioanalytical and biomarker data.

• →Design and execute bioanalytical and biomarker assay development, qualification, and validation activities, including, ligand-binding (ELISA, hybridization ELISA etc.), and immunogenicity assays, both internally and through CRO partners, to support drug candidate selection and regulatory submissions.
• →Generate and oversee bioanalytical data in partnership with PK scientists to support nonclinical programs and inform dose selection for Phase 1–3 clinical siRNA candidates.
• →Serve as the bioanalytical and biomarker lead on multidisciplinary project teams, collaborating with chemistry, platform biology, computational biology, clinical, regulatory, CMC, and other cross-functional partners to advance discovery and early development programs.
• →Manage CRO activities related to bioanalytical and biomarker assay development, qualification, validation, and sample analysis in support of discovery, nonclinical, and CTA/IND-enabling studies.
• →Prepare high-quality bioanalytical summaries, technical reports, and regulatory document contributions, including sections for INDs/CTAs, Investigator’s Brochures, briefing books, and other submission materials.
• →Ensure compliance with applicable regulatory guidelines, SOPs, study protocols, and data integrity principles across all bioanalytical and biomarker-related activities.
• →Lead the preparation, review, and implementation of CRO Statements of Work (SOWs) for bioanalytical and biomarker activities, ensuring clear study scope, deliverables, timelines, assay requirements, sample analysis plans, reporting expectations, and executional alignment with program objectives.
• →Monitor emerging trends and best practices in bioanalytical science, biomarker assay technologies, and analytical platforms, and contribute to the implementation of innovative tools and approaches.

• Ph D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 3–5+ years of relevant industry experience, or M.S. with 6+ years of relevant industry experience.
• Strong expertise in regulated bioanalytical assay development, including assay qualification, validation, and regulatory requirements to support nonclinical and clinical studies.
• Proficiency across multiple bioanalytical assay platforms, including ligand-binding assays, and immunogenicity assays in support of PK, PD, biomarker, and anti-drug antibody assessments.
• Experience managing CRO relationships and externalized bioanalytical activities, including SOW preparation, review, implementation, study execution, data review, and timely delivery of high-quality reports.
• Familiarity with regulatory expectations and guidance relevant to early-stage drug development.
• Demonstrated adaptability, ownership, and collaborative mindset, with the ability to manage diverse responsibilities and shifting priorities in a dynamic, fast-paced environment.
• Excellent problem-solving, analytical, and communication skills, with the ability to interpret complex quantitative data and clearly convey key findings to diverse scientific, clinical, regulatory, and cross-functional audiences.

• Proven experience developing and supporting bioanalytical and biomarker assays for oligonucleotide therapeutics, with experience in siRNA or other RNA-based modalities preferred.
• Experience working with CROs and managing outsourced bioanalytical and biomarker assay activities, including assay development, qualification, validation, sample analysis, data review, troubleshooting, and report finalization.
• Experience supporting IND/CTA-enabling studies and/or early clinical development programs, including generation and interpretation of bioanalytical data for regulatory submissions.
• Knowledge of regulatory bioanalytical guidance and expectations, including FDA, EMA, and ICH guidelines, is a plus.