As a Clinical Development Medical Director in our Oncology Development Unit, you will be responsible for the planning, medical and clinical oversight, and reporting of quality data of assigned clinical trials. In addition, you may be responsible for certain clinical and scientific aspects of a clinical development program, depending on the size and complexity.About the RoleYour responsibilities include, but are not limited to:Provide clinical leadership, medical and scientific strategic input, and contribute to development of trial related documents (e.g., study protocols, informed consent forms, case report forms, committee charters, data analysis plans, reports, publications) for assigned clinical trial(s) consistent with the clinical development plan (CDP)Develop materials for trial-related advisory boards, data monitoring committees, investigators meetings, and protocol training meetingsProvide clinical and scientific input and contribute to 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)Oversee/conduct medical and scientific review of clinical trial data with Clinical Scientific Expert(s)Provide input into final analyses and interpretation including the development of clinical study report, publications and internal/external presentationsSupport the Global Program Clinical Head in ensuring overall safety of the molecule, and may act as a core member of the Safety Management Team, supporting program safety reporting in collaboration with Patient Safety colleaguesSupport the Clinical Development Head with contributing to peer-review of clinical development plans, clinical trial protocols, and other clinical documents across various indications and programs, and support development of therapeutic area strategies, as neededMay contribute to the medical and scientific evaluation for Business Development & Licensing (BD&L) opportunities, as neededContribute to talent and career development of Clinical Development (CD) associates through on-boarding, coaching, and/or mentoring support; develop and foster CD cultureContribute to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule; may serve as speaker for franchise medical/scientific trainingContribute to global initiatives (e.g., process improvement, training, SOP development, other CD line function initiatives)What you’ll bring to the role:4+ years Clinical practice experience (including residency) preferred; Medical Board certification preferredAdvanced knowledge and clinical training in a medical/scientific area Oncology required5+ years of experience in clinical research or drug development from the pharmaceutical/biotechnology industry, preferably spanning clinical activities in Phases I through IV3+ years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting, and publishing) in a global/matrix environmentProven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program levelDemonstrate ability to establish strong scientific partnership with key partnersThorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development processesPeople management experience preferred, especially at the global level (this may include management in a matrix environment)This hybrid role can be based in London or Dublin.Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
#J-18808-Ljbffr