Provides medical and scientific leadership to cross‑functional teams, including clinical development, biostatistics, pharmacokinetics, pharmacovigilance, regulatory, and clinical operations.
Serves as a key medical expert in oncology, guiding the strategy, design, and execution of clinical development programs for anti‑cancer agents.
Leads interactions with global regulatory authorities (e.g., FDA, EMA), in close partnership with regulatory colleagues, and contributes to clinical components of INDs, NDAs, and other regulatory submissions.
Oversees the development of key clinical and scientific documents, including protocols, informed consent forms, clinical study reports (CSRs), investigator materials, regulatory documents, publications, and development plans.
Partners with discovery and translational teams to advance compounds from preclinical stages ...