Executive Director – Bioanalytical Sciences

This is a fully remote position, open to applicants in United States.

📋 Description

• Formulate and implement a comprehensive bioanalytical strategy, operational model, standards, and capability roadmap for the organization.

• Direct bioanalytical support across research, translational, and clinical initiatives, covering PK, pharmacodynamic, immunogenicity, neutralizing antibody, biomarker, and specific program assays.

• Provide scientific leadership for assay strategy, platform selection, critical reagents, method development, qualification and validation, technology transfer, sample analysis, data interpretation, and management of the assay lifecycle.

• Ensure that assays and data meet purpose, maintaining scientific rigor, compliance with regulatory requirements, and accessibility for pivotal program decisions and milestones.

• Address complex issues related to assays, data, quality, and vendor interactions in collaboration with Quality, program teams, and external laboratories.

• Manage or supervise bioanalytical content for regulatory submissions, briefing documents, health authority communications, responses, and development reports.

• Represent Bioanalytical Sciences in program teams and governance forums, articulating scientific findings, risks, trade-offs, resource needs, and recommendations.

• Build, lead, and cultivate the Bioanalytical Sciences department through organizational design, recruitment, coaching, performance management, succession planning, and skill development.

• Develop and oversee resource allocation across employees, CROs, specialized laboratories, consultants, and technology partners.

• Lead the evaluation, selection, contracting, onboarding, governance, performance management, issue escalation, and relationship management of external laboratories.

• Manage functional budgets, headcount planning, consultant requirements, capacity forecasting, and resource distribution.

• Establish processes, metrics, systems, and vendor oversight practices that enhance quality, efficiency, accountability, and readiness for inspection; assess technologies that improve scientific and operational performance.

⛳️ Requirements

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

• Generally, 15 or more years of progressive bioanalytical experience within biotechnology, pharmaceutical, or CRO settings.

• Significant responsibility for functional and personnel leadership.

• Proven track record of leading bioanalytical strategy across various programs and development phases, from nonclinical development to clinical studies and regulatory engagement.

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

• Broad understanding of PK, pharmacodynamic and biomarker assays, ligand-binding assays, anti-drug antibody and neutralizing antibody assays, cell-based or functional assays, flow cytometry, molecular techniques, and LC-MS/MS.

• Strong familiarity with global bioanalytical regulatory standards, GLP and GCP-regulated activities, data integrity, inspection readiness, and support for regulatory submissions.

• Demonstrated experience in building and leading high-performing teams and managing deliverables through CROs, specialized laboratories, consultants, and other external partners.

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

• Solid scientific judgment, strong cross-functional influence, and capability to function effectively in a dynamic, fast-paced biotechnology environment.

🏝️ Benefits

• Option for remote work.

• Chance to work on potentially best-in-class therapies for severe autoimmune diseases.

• Opportunity to establish and lead the Bioanalytical Sciences function.

• Professional growth through coaching, skill development, and responsibilities in succession planning.