Senior Director, Clinical Development - Prostate Cancer
Core
Lead clinical development strategy and execution for prostate cancer radiopharmaceutical assets from IND to Phase 3 registrational studies.
Role type
Senior Director, Clinical Development (Oncology)
Builds
Clinical development plans, protocols, and regulatory submissions for prostate cancer therapies.
Domain
Oncology / Radiopharmaceuticals
Required skills
Clinical trial design and execution (Phase 1-3), regulatory authority interactions, team leadership, protocol writing, medical monitoring, strategic planning, cross-functional collaboration, GCP/ICH compliance.
Preferred skills
Radiopharmaceutical experience, prostate cancer drug development experience, NDA/MAA preparation.
Technologies
None stated.
Responsibilities
Design clinical development plans for nominated drug candidates; lead internal study teams and partner with investigators/CROs; contribute to writing protocols and clinical study reports; conduct investigator meetings and site qualification visits; execute drug development strategic plans; translate research findings into clinical opportunities; oversee Data Review and Independent Data Monitoring Committees; manage regulatory submissions for prostate cancer indications; recruit and manage a team of medical directors and clinical scientists.
Seniority
Senior Director, strategic leadership with hands-on execution.