The Associate Clinical Development Medical Director (Assoc. CDMD) is responsible for the scientific and medical strategy of assigned clinical trial(s), medical and scientific monitoring, and reporting of quality data. May be responsible for the scientific and medical strategy of assigned sections of a clinical development program, depending on the size and complexity.
1)Provides clinical leadership, medical and scientific strategic input, and contributes to development of trial related documents (e.g., CTPs, informed consent form, case report forms, data monitoring committee charters, data analysis plan, reports, publications) for assigned clinical trial(s) consistent with Integrated Development Plan (IDP); develops materials for trial-related advisory boards, data monitoring committees, investigators meetings, and protocol training meetings for Novartis local medical organizations 2)Provides medical and scientific input and contributes to clinical sections of trial and program level regulatory documents (e.g., Investigator's Brochures, Health Authority briefing books, safety updates, submission dossiers, and responses to Health Authorities) 3)In collaboration with appropropriate Clinical Trial Team (CTT) members: a)Ensures direct medical support of trials as needed and may act as medical monitor b)Conducts ongoing medical and scientific review of clinical trial data with Clincal Scientific Expert(s) c)Manages patient safety and reports on trial data to safety and clinical boards (e.g., Safety Management Team (SMT), GCT, GPT) d)Provides input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations 4)Under the direction of the (Sr.) GPCH or (Sr.) CDMD, contributes to ensuring overall safety of the compound for assigned trial(s) in collaboration with Patient Safety 5)Supports Therapeutic Area Head (TAH) with contributing to peer-review of IDPs, CTPs, and other clinical documents across various indications and programs 6)Supports development of TA strategies, as needed 7)May contribute to the medical and scientific evaluation for Business Development & Licensing (BD&L) opportunities 8)Contributes to talent and career development of CD associates through on- boarding, coaching, and/or mentoring support; develops and fosters CD culture; and may contribute to the performance evaluation of CTT members 9)Contributes to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training 10)Contributes to global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)
Evidence of quality medical and scientific strategic input as well as timely delivery of high quality CTPs and other clinical deliverables Applies effective clinical research methodology, including trial design/analyses, efficacy endpoints, safety assessments, and risk management across disease area and development phases Evidence of quality medical and scientific review of clinical trial data, development of CSRs Supports TA through high quality contributions to IDP and protocol reviews Supports timely development of quality disease/program clinical standards, publications, and internal/external presentations Evidence of quality contributions to clinical sections of regulatory documents, Investigator's Brouchures, briefing books, safety udpates and submission dossiers Clearly demonstrates Novartis Values and Behaviors