17 ago
|
Development
|
España
17 ago
Development
España
Summary
The Senior* Clinical Development Medical Director (Sr* CDMD) will lead the end-to-end strategy and execution of assigned renal clinical development program(s) across the full Research, Development and Commercial (RDC) continuum; from early development through pivotal/registrational phases. This is a key leadership role requiring hands-on experience in both early and late phase renal drug development. With the ability to translate emerging data into a clear clinical and regulatory path, drive delivery in a global matrix, and ensure rigorous benefit–risk decision making throughout the program lifecycle.
About the Role
Major accountabilities:
Your responsibilities will include, but are not limited to:
- Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
- Leading development of clinical sections of trial and program level regulatory documents
- Driving execution of the assigned clinical program and/or clinical trial in partnership with global line functions,
assigned Global Trial Directors (GTDs), and regional/country medical associates, where applicable
- Supporting (Senior) Integral Program Clinical Head (GPCH) in ensuring overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team (SMT), supporting overall program safety reporting in collaboration with Patient Safety colleagues
- Supporting the Clinical Development Head (CDH) by providing medical input into Clinical Development Plan (CDP), Integrated Development Plan (IDP) and Clinical Trial Protocol (CTP) reviews, and contributing to/driving development of disease clinical standards for new disease areas
- As a medical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards
- May work with BR (Biomedical Research/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) proj
📌 Senior* Clinical Development Medical Director (España)
🏢 Development
📍 España