Medical Director, Study Responsible Physician - Late Development, Prostate

Role: Director of Clinical Research Oncology responsible for leading late-stage clinical trials within a global oncology development program. Main objectives include ensuring flawless study execution, strategic protocol development, and cross-functional collaboration to advance oncological treatments. Responsibilities encompass overseeing study start-up, medical review of data, liaising with investigators, managing CRO/vendor performance, and supporting regulatory submission activities. Required qualifications include a medical degree (MD or equivalent), post-doctoral fellowship, and at least 3 years of relevant oncology or urology clinical research experience, with a preference for uro-oncology specialization. Essential skills involve clinical trial design, regulatory knowledge, cross-disciplinary collaboration, and stakeholder management; preferred skills include business acumen, informatics, and strategic analysis. The role demands a high level of scientific expertise in cancer research, experience in GxP environments, and strong communication skills. Travel of up to 20-30% internationally and domestically is expected. High-value biopharma specifics include focus on oncology, late-stage development, and regulatory support for NDA/MAA submissions. The position reports directly to a Clinical Leader, with a key role in study governance and external scientific interactions. Work setup includes flexibility for domestic and international travel.