06 ago
|
Novartis UK
|
Barcelona
06 ago
Novartis UK
Barcelona
Hybrid Working Are you passionate about shaping the future of clinical development and making a meaningful impact in Cardiovascular/Stroke medicine? We are looking for an experienced and visionary Senior Clinical Development Medical Director (Sr CDMD) to take the lead in driving the strategic planning and execution of our cutting-edge clinical programs. As the internal medical/clinical expert in his/her field, the Sr CDMD is the Global clinical/medical lead of a section of a clinical development program or one or more large, complex trial(s), under the leadership of the Global Program Clinical Head (GPCH).
This is a key leadership role requiring hands-on experience in cardiovascular/stroke/anticoagulation clinical 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 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) 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 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 May 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 Development & Licensing) including target identification and due diligences together with other medical matters, as needed. MD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific area; 7 years of experience in clinical research or drug development ~ Experience in an academic clinical research or industry environment spanning clinical activities, particularly in Ph3 trials ~ Working knowledge of cardiovascular disease and/or stroke medicine, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research reports ~ Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes ~ Previous global people management experience is preferred, though this may include management in a matrix environment.
Why Novartis
Helping people with disease and their families takes more than innovative science. Short term incentive bonus ~ Health insurance ~Adaptable working arrangements ~ learning and development opportunities
📌 Senior Clinical Development Medical Director (Barcelona)
🏢 Novartis UK
📍 Barcelona