Executive Director, Head of Bioanalytical Sciences

The role

The Executive Director, Head of Bioanalytical Sciences will lead the company's bioanalytical strategy and execution across research, translational, and clinical development. This person will serve as the senior scientific authority for bioanalytical and biomarker assays and manage resources across internal headcount, CROs, and external partners.

What you will do

• Define and execute the company-wide bioanalytical strategy, operating model, standards, and capability roadmap.
• Lead bioanalytical support across research, translational, and clinical programs.
• Provide scientific oversight for assay strategy, platform selection, method development, and validation.
• Ensure assays and data are fit for purpose and compliant with regulatory expectations.
• Lead resolution of complex assay, data, quality, 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.
• Develop and manage a scalable resourcing model across employees, CROs, and consultants.
• Lead external laboratory evaluation, selection, and relationship management.

Required qualifications

• PhD or advanced equivalent degree in biochemistry, immunology, pharmacology, analytical chemistry, molecular biology, or a related scientific discipline.
• 15 or more years of progressive bioanalytical experience in biotechnology, pharmaceutical, or CRO environments.
• Significant functional and people leadership responsibility.
• Demonstrated success leading bioanalytical strategy across multiple programs and development stages.
• 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, f
• 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 cros
• Sound scientific judgment, strong cross-functional influence, and the ability to operate effectively in a growing, fast-paced biotechnology environment.

About the company

dianthustherapeutics is developing potentially best-in-class therapies for patients living with severe autoimmune diseases.