Global Development Medical Director, Cell Therapy Oncology

Role: Global Development Medical Director, supporting late-phase clinical programs within AstraZeneca's oncology portfolio, with responsibilities spanning clinical trial design, safety monitoring, data interpretation, and global regulatory submissions. Main objectives include ensuring the scientific validity, ethical integrity, and regulatory compliance of clinical studies, contributing to product registration activities, and providing expert medical oversight. Core responsibilities involve collaborating cross-functionally with clinical teams, external consultants, sites, and regulatory bodies; leading risk-benefit assessments; developing clinical protocols and reports; and supporting safety and efficacy data review. The role may also entail process improvement initiatives, mentorship, and contributions to cross-asset working groups. Qualifications: MD or PhD with industry or academic experience in drug development, extensive knowledge of GCP, ICH, FDA, EMEA regulations, and a demonstrated understanding of oncology therapeutic areas. Experience in late-phase (Phases 3 or 4) clinical trials is essential. Preferred: clinical oncology training and expertise. High-Value: focus on oncology, late-phase trials, medical monitoring, regulatory interactions, clinical protocol development, safety oversight, and cross-functional collaboration in a matrix environment. Work setup involves a flexible, partly in-office environment with a minimum of three days per week onsite; travel requirements are not specified.