Associate Director, Bioanalysis (Cell Therapy)

Role: Senior leader responsible for developing and executing bioanalytical strategies supporting clinical cell and gene therapy programs, focusing on assay development, validation, and external vendor management. Objectives include enabling regulatory submissions, clinical decision-making, and advancing next-generation cell therapies. Responsibilities encompass designing end-to-end bioanalytical plans for PK/PD, immunogenicity, and biomarkers; overseeing assay tech transfer; managing external labs and CROs; analyzing complex datasets; and communicating findings for scientific dissemination. Requirements: PhD in immunology, cellular or tumor biology with 7+ years industry experience in cell therapy; proven expertise in regulated bioanalysis (PK/CK, PD, immunogenicity); experience leading biospecimen analysis; proficiency with analysis software (e.g., Cytobank, Tableau); deep knowledge of cell therapy biology; understanding of global regulatory standards; proven leadership and cross-functional collaboration skills; excellent data interpretation and communication abilities. Preferred: track record from early development through clinical phases, experience with flow cytometry, molecular assays, automation, and data governance; peer-reviewed publications; vendor negotiation skills. High-value specifics: focus on innovative cell therapies, regulatory compliance, assay robustness, and scientific communication within a dynamic, collaborative environment. Work setup: in-office with flexible arrangements.