Director, Bioanalytical

What You’ll Do
The Director of Bioanalytical Sciences provides strategic, scientific, and operational leadership for development, validation, and execution of bioanalytical strategies supporting precision peptide therapeutics across discovery, preclinical, and clinical stages.
Key responsibilities:
- Lead bioanalytical assay development, validation, transfer, and execution.
- Lead PK, PD, immunogenicity (ADA/NAb), and biomarker assessments.
- Develop phase-appropriate bioanalytical strategies compliant with FDA, EMA, ICH, and other global requirements.
- Serve as bioanalytical subject matter expert on cross-functional teams (Research, Clinical Development, Clinical Pharmacology, Regulatory Affairs, CMC, Quality).
- Oversee external CROs and laboratory partners (data quality, timelines, budget, operational excellence).
- Review, interpret, and communicate bioanalytical/PK/immunogenicity/biomarker data for development and regulatory decisions.
- Author/review INDs, clinical study reports, bioanalytical reports, and responses to health authority inquiries.
- Build, mentor, and develop bioanalytical teams; identify and implement emerging technologies/best practices.

What You Bring
- MS with 9+ years’ experience or PhD with 7+ years bioanalytical experience in biotech/pharma, including leadership for preclinical/clinical programs.
- Deep expertise in LC-MS/MS, biomarker assays, and immunogenicity testing for peptides/small molecules.
- Proven bioanalytical method development and validation experience.
- Strong knowledge of GLP/GCLP and bioanalytical regulatory guidance (ICH M10).
- Experience managing CROs/external labs (assay transfer, validation oversight, troubleshooting, vendor governance).
- Leadership supporting Phase I–III studies and IND/BLA/NDA support.
- Metabolic disease/obesity/endocrinology/peptide therapeutics experience desirable.
- Excellent communication/data interpretation; people-management and scalable operations building skills.