Summary: As our Clinical Development Medical Director in our Immunology Development Unit, you will be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data.
About the Role: The Clinical Development Medical Director (CDMD) for Rheumatology is the clinical leader of defined program level activities (e.g., submission activities, briefing books, etc.
), or a large, complex trial, under the leadership of the (Sr.) GPCH.
May lead a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase).
Your responsibilities include, but are not limited to:
Provide clinical leadership and medical strategic input for deliverables in the assigned project/program.
Deliverables may include sections of individual protocols consistent with the IDP, data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications (e.g., 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/conduct medical and scientific review of trial data with Clinical Scientific Expert(s).May be the Program Manager of other associates (e.g., CSE).
May function as study medical monitor.Support SR/GPCH in ensuring overall safety of the molecule.
May be a core member of the Safety Management Team (SMT), and supports program safety reporting (e.g., PSURs, DSURs, and safety related documents) in collaboration 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 for disease areas.Provide support to the (Sr.) GPCH or TAH in interactions with external partners (e.g., regulatory authorities, KOLs, data monitoring boards, AD Boards, patient advocacy groups), internal partners (e.g., CTT, Research, Translational Medicine, GMA, Marketing, HE∨), and decision boards.Work with NIBR (Novartis Institute of Biomedical Research)/Translational Medical Sciences to drive transition of pre-PoC projects to DDP and with BD&L; including target identification and due diligence together with additional matters.Ensure career development of Program reports and clinical colleagues through active participation in performance management and talent planning processes.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 (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives).Minimal Requirements: MD (or equivalent medical degree) is required.
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