Director, Oncology Bioanalytical Strategy Lead
AstraZeneca
Director-level position leading bioanalytical strategy for oncology programs within AstraZeneca's Integrated Bioanalysis Global Team. Responsible for designing and implementing robust bioanalytical strategies including pharmacokinetics, immunogenicity, and biomarkers to support pipeline advancement, with cross-functional collaboration and regulatory engagement.
Responsibilities
- Lead design and implementation of bioanalytical strategies for oncology portfolio programs including PK, immunogenicity, and biomarker endpoints
- Serve as IBA project lead for selected programs, collaborating with internal and external laboratory teams on assay development and validation
- Manage stakeholder expectations and serve as primary interface between bioanalytical scientists and cross-functional project teams
- Engage with regulatory agencies across multiple countries on strategy mitigation, regulatory submissions, and authority responses
- Contribute to scientific excellence through presentations, publications, and strategic department initiatives
Requirements
- Bachelor's degree in immunology, molecular biology, or related field plus 10+ years relevant experience; or Master's degree plus 7+ years biopharmaceutical industry experience
- Proven subject matter expertise in regulated bioanalysis across multiple modalities and therapeutic approaches
- In-depth knowledge of complex biologics, antibody-drug conjugates, and bioanalytical methodology
- Experience leading bioanalytical strategy as project lead in diverse teams and advancing portfolio programs
- Proficiency with analytical techniques including ligand binding assays, LC-MS, molecular assays, flow cytometry, and immunoassays
- Experience with assay transfer, CRO oversight, data interpretation, and preclinical/clinical study delivery
- Knowledge of global regulatory expectations and contribution to IND, CTA, IB, and NDA/BLA submissions
Vacancy posted 27 days ago
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