15 ago
|
Novartis
|
Cataluña
Salary Range:85,100.00 - 158,100.00Job Description SummaryThe 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.Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical programLeading development of clinical sections of trial and program level regulatory documentsDriving execution of the assigned clinical program and/or clinical trial in partnership with integral line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates,
where applicableSupporting (Senior) Global 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 colleaguesSupporting 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 areasAs a medical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boardsMay work with BR (Biomedical Research/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L; (Business Developm
📌 Senior Clinical Development Medical Director (Cataluña)
🏢 Novartis
📍 Cataluña