Executive Director, Head of Bioanalytical Sciences

Responsibilities

• Define and execute the company-wide bioanalytical strategy, operating model, and capability roadmap
• Lead bioanalytical support across research, translational, and clinical programs (PK, PD, immunogenicity, etc.)
• Provide scientific oversight for assay strategy, method development, qualification, and validation
• Ensure assays and data are fit for purpose and compliant with regulatory expectations
• Lead resolution of complex assay, data, or vendor issues
• Own or oversee bioanalytical content for regulatory submissions and health authority interactions
• Represent Bioanalytical Sciences on program teams and governance forums
• Build, lead, and develop the Bioanalytical Sciences function, including recruitment and coaching
• Develop and manage a scalable resourcing model across employees, CROs, and consultants
• Lead external laboratory evaluation, selection, and relationship management
• Own functional budgets, headcount plans, and resource allocation

Requirements

• PhD or advanced equivalent degree in biochemistry, immunology, pharmacology, analytical chemistry, or molecular biology
• 15+ years of progressive bioanalytical experience in biotechnology, pharmaceutical, or CRO environments
• Demonstrated success leading bioanalytical strategy across multiple programs and development stages
• Deep expertise in bioanalytical method development, qualification, validation, and lifecycle management
• Broad knowledge of relevant platforms (PK, PD, biomarker, ligand-binding, ADA, NAb, cell-based, flow cytometry, LC-MS/MS)
• Strong knowledge of global bioanalytical regulatory expectations, GLP and GCP-regulated work, and data integrity
• Proven experience building and leading high-performing teams and managing delivery through CROs
• Demonstrated ability to manage budgets, headcount, and capacity plans
• Sound scientific judgment and strong cross-functional influence