Executive Director, Head of Bioanalytical Sciences

• Ensure assays and data are fit for purpose, scientifically rigorous, compliant with applicable regulatory expectations, and available to support key program decisions and milestones.

• Lead resolution of complex assay, data, quality, or vendor issues in partnership with Quality, program teams, and external laboratories.

• Own or oversee bioanalytical content for regulatory submissions, briefing packages, health authority interactions, responses to questions, and development reports.

• Represent Bioanalytical Sciences on program teams and governance forums, clearly communicating scientific conclusions, risks, trade-offs, resource needs, and recommendations to technical and nontechnical audiences.

• Build, lead, and develop the Bioanalytical Sciences function, including organizational design, recruitment, coaching, performance management, succession planning, and capability development.

• Develop and manage a scalable resourcing model across employees, CROs, specialty laboratories, consultants, and technology partners.

• Lead external laboratory evaluation, selection, contracting input, onboarding, governance, performance management, issue escalation, and relationship management.

• Own functional budgets, headcount plans, consultant needs, capacity forecasts, and resource allocation across competing programs.

• Establish practical processes, metrics, systems, and vendor oversight practices that support quality, speed, accountability, and inspection readiness, while evaluating new technologies that improve scientific and operational performance.

Experience

• PhD or advanced equivalent degree in biochemistry, immunology, pharmacology, analytical chemistry, molecular biology, or a related scientific discipline.

• Typically, 15 or more years of progressive bioanalytical experience in biotechnology, pharmaceutical, or CRO environments, including significant functional and people leadership responsibility.

• Demonstrated success leading bioanalytical strategy across multiple programs and development stages, from nonclinical development through clinical studies and regulatory interactions.

• Deep expertise in bioanalytical method development, qualification, validation, transfer, troubleshooting, sample analysis, data review, and assay lifecycle management.

• Broad knowledge of relevant platforms, including PK, pharmacodynamic and biomarker assays, ligand-binding assays, anti-drug antibody and neutralizing antibody assays, cell-based or functional assays, flow cytometry, molecular methods, and LC-MS/MS, as applicable to the portfolio.

• Strong knowledge of global bioanalytical regulatory expectations, GLP and GCP-regulated work, data integrity, inspection readiness, and regulatory submission support.

• Proven experience building and leading high-performing teams and managing delivery through CROs, specialty laboratories, consultants, and other external partners.

• Demonstrated ability to manage budgets, headcount and capacity plans, prioritize resources across a portfolio, and communicate complex scientific and operational matters clearly to executives and cross-functional teams.

• Sound scientific judgment, strong cross-functional influence, and the ability to operate effectively in a growing, fast-paced biotechnology environment.

Originally posted on Himalayas

• Director of Bioanalytical Sciences
• Biomarker Science
• Clinical Assay Development Director
• Bioanalytical Sciences Manager

Source: Himalayas