Major accountabilities:

• 1) Provides clinical oversight, medical and scientific 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) and Clinical Development Plan (CDP); 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 apropropriate Clinical Trial Team (CTT) members:
• a)Ensures direct medical oversight and support of trials as needed and acts as the medical monitor which includes data, safety and medical scientific review of all clinical trial documents and data
• b)Conducts ongoing medical and scientific review of clinical trial data with support of Clincal Scientific Expert(s) and CDDs
• c)Manages patient safety and reports on trial data to safety and clinical boards (e.g., Safety Management Team (SMT), GCT, GPT) under leadership of the Sr CDMD or GPCH
• d)Provides input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations, with appropriate oversight from Medical Lead
• 4) Under the direction of the GPCH or (Sr.) CDMD, supports assessment of overall benefit/risk assessment and monitor safety of the molecule for the assigned section on an ongoing basis and may be a member of the Safety Management Team (SMT), and supports 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
• 5) 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 evalsuation of CTT members
• 6) 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
• 7) Contributes to global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)
• 8) May be assigned to lead clinical trial(s) as Clinical Scientific Lead and provide leadership and guidance for all clinical aspects of a clinical trial in close collaboration with the assigned medical monitor and/or CDMD.

Key performance indicators:

• Evidence of quality medical and scientific data 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 Brochures, briefing books, safety updates and submission dossiers
• Clearly demonstrates Novartis Values and Behaviors (i.e. Innovation, Quality, Collaboration, Performance, Courage and Integrity.