Principal Scientist, Bioanalytical Specialist

Provide scientific and strategic leadership for clinical-stage bioanalytical assays, including pharmacokinetic (PK), pharmacodynamic (PD), biomarker, and immunogenicity assays.

Serve as the clinical bioanalysis subject matter expert for assay validation, study conduct, sample analysis, data interpretation, and regulatory compliance.

Execute integrated bioanalytical strategies that support first in human Phase 1 through Phase 3 clinical development programs.

Provide scientific and operational oversight of outsourced clinical bioanalysis at CROs and partner laboratories, including method transfer, validation, sample analysis, troubleshooting, and data delivery.

Support vendor selection, contracting, study start-up, performance monitoring, and risk mitigation for bioanalytical vendors.

Author, review, and provide SME input for bioanalytical sections of clinical and regulatory documents, including protocols, lab manuals, clinical study reports, investigator brochures, BLAs, and responses to health authority questions.

Contribute to interpretation and integration of PK, PD, biomarker, and immunogenicity data to inform dose selection, development strategy, and program decision-making.

Provide SME support for regulatory inspections, audits, and inspection-readiness activities related to clinical bioanalysis.

Present bioanalytical strategies, study updates, risks, and recommendations to project teams, governance committees, and senior leadership.

Stay current with emerging bioanalytical technologies, industry trends, and evolving regulatory expectations to continuously strengthen organizational capabilities.

PhD in biochemistry, immunology, pharmaceutical sciences, or a related discipline with 7+ years of relevant biopharmaceutical industry experience.

Demonstrated experience supporting biologics or other complex therapeutic modalities across First in Human, early- and late-stage clinical development programs.

Experience providing scientific oversight of CROs, external laboratories, technology vendors, and/or academic collaborators.

Ability to work independently, manage multiple priorities, and drive complex scientific initiatives in a fast-paced, highly collaborative environment.

Passion for rare disease research and a commitment to translating rigorous science into meaningful benefits for patients.