Director, Oncology Bioanalytical Strategy Lead

Role: Lead bioanalytical strategy development and implementation for AstraZeneca's oncology portfolio within the Integrated Bioanalysis (IBA) team, supporting preclinical and clinical programs. Responsibilities: design and oversee robust assays for PK, immunogenicity, and biomarkers; collaborate with internal teams, CROs, and external labs; serve as IBA project lead for select oncology programs; ensure assay validation, regulatory compliance, and timely delivery; contribute to regulatory filings and scientific publications; provide scientific oversight and strategic input across modalities including biologics, ADCs, radioconjugates, and cell therapies. Requirements: Bachelor's (10+ years) or Master's (7+ years) in immunology, molecular biology, or related; extensive experience in regulated bioanalysis of biologics and complex modalities; proven track record in assay development, transfer, and data interpretation; familiarity with regulatory submissions (INDs, CTAs, NDAs/BLAs); strong knowledge of analytical techniques such as ligand binding assays, LC-MS, PCR, flow cytometry; ability to lead cross-functional teams and manage multiple projects. Preferred: experience with immuno-oncology, antibody-drug conjugates, radioconjugates, cell therapies, and immunology expertise; publication record; stakeholder management in global regulatory environments. High-value specifics: oncology, immuno-oncology, biologics, ADCs, radioconjugates, clinical-stage development, regulatory interactions, GxP compliance. Work setup: onsite in Gaithersburg, MD or Boston, MA, with potential for cross-functional collaboration.