Clinical Development Medical Director

The Clinical Development Medical Director (CDMD) is the clinical leader of a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase), or a large, complex trial, under the leadership of the (Sr.) GPCH. About The Role Your responsibilities include, but are not limited to: Provide clinical leadership and medical strategic input for deliverables in the assigned project/program, including sections of individual protocols, data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications such as IBs, Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities. Drive execution of the section of the program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates. Oversee or conduct medical and scientific review of trial data with Clinical Scientific Expert(s). May act as Program Manager of other associates and/or study medical monitor. Support SR/GPCH in ensuring overall safety of the molecule, including core membership of the Safety Management Team (SMT) and collaboration on program safety reporting (e.g., PSURs, DSURs, and safety related documents) with Patient Safety. Support the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards. Provide support to the (Sr.) GPCH or TAH in interactions with external partners (regulatory authorities, KOLs, data monitoring boards, AD Boards, patient advocacy groups) and internal partners (CTT, Research, Translational Medicine, GMA, Marketing, HE&OR), and decision boards. Work with BR (Biomedical Research)/Translational Medical Sciences to drive transition of pre‑PoC projects to DDP and with BD&L including target identification and due diligences together with additional matters. Ensure career development of program reports and clinical colleagues through active participation in performance management and talent planning processes, and provide onboarding, training, and mentoring support. Contribute to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise. May serve on or lead global initiatives such as process improvement, training, SOP development, and other Clinical Development line function initiatives. Requirements MD (or equivalent medical degree) is required. Medical Board certification preferred. 4+ years clinical practice experience (including residency) is preferred. Possess advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub‑specialty) is required. 5+ years’ experience in clinical research or drug development from the pharma/biotech industry spanning clinical activities in Phases I through IV. 3+ years of contribution to and accomplishment in all aspects of conducting clinical trials (planning, executing, reporting, publishing) in a global/matrix environment. Showcase advanced knowledge of assigned therapeutic area. Demonstrate ability to establish strong scientific partnership with key partners. Need thorough knowledge of GCP, trial design, statistical analysis methodology, and regulatory/clinical development process. People management experience preferred, including management in a matrix environment. Global people management preferred. Exhibit excellent business communication and presentation skills. Possess strong interpersonal skills. Adept with excellent negotiation and conflict resolution skills. \"Final job title (Associate Clinical Development Director, level 5 / Clinical Development Director, Level 6/ Senior Clinical Development Director, Level 6) and associated responsibilities will be commensurate with the successful candidates’ level of expertise\" Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us Learn more here: You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: #J-18808-Ljbffr