1! Cardiovascular diseases are the Number 1 cause of death globally, according to the World Health Organization. At Novartis, we focus on developing new treatment options for people living with serious cardio-Metabolic diseases including heart failure and atherosclerosis.
We are Novartis. Join us and help reimagine medicine!
As a Clinical Development Medical Director in the Cardio Renal Metabolic (CRM) Franchise, you will be the Clinical Leader of defined program level activities for atherosclerotic cardiovascular disease (e.g. submission activities, briefing books etc.), or a large, sophisticated trial, under the leadership of the Senior Global Program Clinical Head (GPCH). You may lead a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase).
This opportunity is located at the Novartis East Hanover site, and will not have the ability to be located remotely.
Your Key Responsibilities: * Providing clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program, which include: clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications. * Leading development of clinical sections of trial and program level regulatory documents (e.g., Investigator's Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities). * Driving execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates. * Coordinating and conducting ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s). * Support Senior GPCH in ensuring overall safety of the molecule for the assigned section, be a core member of the Safety Management Team (SMT), and support overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety. * Support the Clinical Development Head (CDH) by providing medical input into IDP and CTP reviews and driving development of disease clinical standards for new disease areas. * Support the Senior GPCH or CDH in interactions with external partners (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal partners (e.g., Clinical Trial Team, Research, Translational Medicine, Global Medical Affairs, Marketing, HE∨), and internal decision boards. * Partner with NIBR (Novartis Institute of Biomedical Research) and Translational Medical Sciences to drive transition of pre-PoC projects to DDP (Development Decision Point) and with BD&L.