Associate Clinical Dev Medical Director

Job Description

Your responsibilities include, but are not limited to: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, investigator 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 Assoc. CDMD Page 2 of 3 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)Minimum requirements MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required, with Medical Board certification Fluent in oral and written English 3 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. 2 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry Working knowledge of the assigned disease area is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level Assoc. Demonstrated ability to establish effective working relationship with key investigators Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes; Strong communication skills, written and oral Strong interpersonal skills, Strong negotiation and conflict resolution skills, proven ability to work independently or in a cross-functional team settingWhy consider Novartis 750 million. That s how many lives our products touch. And while we re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people s lives We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you re given opportunities to explore the power of digital and data. Where you re empowered to risk failure by taking smart risks, and where you re surrounded by people who share your determination to tackle the world s toughest medical challenges. We are Novartis. Join us and help us reimagine medicine. Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.,

Keyskills :
networkingmarketing insurancemacromedia director case report formsadobe creative suite strong communication skillsstrong interpe