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Clinical development medical director - crm

Basel
Novartis
Inserat online seit: 20 August
Beschreibung

Clinical Development Medical Director - CRMJoin to apply for the Clinical Development Medical Director - CRM role at NovartisContinue with Google Continue with GoogleClinical Development Medical Director - CRM2 days ago Be among the first 25 applicantsJoin to apply for the Clinical Development Medical Director - CRM role at NovartisSummaryThe Clinical Development Medical Director (CDMD) is the clinical leader of a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase), or a large, complex trial, under the leadership of the (Sr.) GPCH.SummaryThe Clinical Development Medical Director (CDMD) is the clinical leader of a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase), or a large, complex trial, under the leadership of the (Sr.) GPCH.About The RoleYour 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 associatesOversee/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 monitorSupport 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 SafetySupport 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&OR), and decision boards)Work with BR (Biomedical Research)/ Translational Medical Sciences) to drive transition of pre-PoC projects to DDP and with BD&L including target identification and due diligences together with additional mattersEnsure career development of Program reports and clinical colleagues through active participation in performance management and talent planning processes. Provide on-boarding, training, & mentoring supportContribute 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 RequirementsMD (or equivalent medical degree) is required.Medical Board certification preferred. 4+ years Clinical practice experience (including residency) is preferredPossess advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) is required.5+ years’ experience in clinical research or drug development from the pharma/biotech industry spanning clinical activities in Phases I through IV.3+ years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting, and publishing) in a global/matrix environmentShowcase advanced knowledge of assigned therapeutic areaDemonstrate ability to establish strong scientific partnership with key partnersNeed thorough knowledge of GCP, trial design, statistical analysis methodology, and regulatory/ clinical development processHave people management experience preferred, this may include management in a matrix environment. Global people management is preferred.Exhibit excellent business communication and presentation skillsPossess strong interpersonal skillsAdept with excellent negotiation and conflict resolution skillsWhy Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-cultureYou’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/networkWhy Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureJoin our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/networkBenefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewardsSeniority levelSeniority levelDirectorEmployment typeEmployment typeFull-timeJob functionJob functionResearch, Analyst, and Information TechnologyIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at Novartis by 2xSign in to set job alerts for “Director Clinical Development” roles.Continue with Google Continue with GoogleContinue with Google Continue with GoogleDirector/ Sr Director - Clinical Development (Pulmonology)(Lead) Clinical Director - Alzheimer's diseaseDirector- Senior Director Global Clinical Research*Senior Clinical Development Director - RenalClinical Development Medical Director - Renal **80-100%Clinical Development Medical Director - RenalDirector- Senior Director Global Clinical ResearchDirector- Senior Director Global Clinical ResearchClinical Development Medical Director - CardiovascularClinical Development Medical Director - RheumatologySenior Clinical Development Medical Director - RenalSenior Clinical Development Medical Director - RenalLead Medical Director, Product Development, Cardiovascular MetabolicClinical Development Medical Director ImmunologyLead Medical Director, Product Development, HematologyDirector, Global Value, Access & Pricing; HematologyPrincipal Medical Director Multiple Sclerosis & NeuroimmunologyWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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