US-NJ, Medical Director, Global Med Affairs, Cell & Gene Therapies 212268BR-MZ
Medical Director, Global Med Affairs, Cell & Gene Therapies
East Hanover, NJ
Research & Development
The Medical Director, Global Medical Affairs CGTU will be responsible for providing strategic medical and scientific leadership for CTL019. Provides medical input into clinical trial strategies and works cross-functionally to define, plan and implement exploratory studies. Will lead the planning, execution and reporting of the European Regional Medical Affairs program on time, within budget and in compliance with Novartis processes and regulatory requirements, liaising closely with relevant KOLs and with Global and European Medical Affairs functions. Analyze data from clinical trials and produce reports as indicated. Generation of key data through registries, non-registration trials; health outcomes research and analytics Participates in strategic planning as part of the Development and Commercial initiatives, where appropriate. Extensive interactions with academic thought leaders in order to optimize clinical trial strategies. Educates colleagues within the company as well as health care professionals outside the company related to assigned compound/s where appropriate. Ensuring effective design of protocols and conducting clinical studies, both independently and in partnership with other clinicians and external consultants. Support & establish strategy and drug development plans for the CTL019 program for Region Europe in collaboration with ORE clinical trial team (CTT) and European KOLs. Influence their adoption within NVS and implement them in the organization. Identify & develop potential life cycle management opportunities.
Generation of key data through registries,non-registration trials;health outcomes research&analytics Develop relationships with leading medical experts&establishes relationships with investigators to participate in trials or to propose their own studies in their areas of interest. Manage annual budgets,conducting ROI assessments of programs,ensure proper execution/collaboration of clinical trials&updating senior management on current&future product development strategies/issues for area of expertise. Represents Novartis from an external perspective,such as in regulatory meetings,meeting with health authorities&medical conferences For Regional trials: Responsible for the design/preparation of the study protocol&obtaining approval by the protocol review committee (PRC),in addition to preparing&submitting the study report/publication planning in collaboration with CTT members. Responsible for execution of clinical trials(trial timelines,budget,resources,safety,eligibility,enrollment,data consistency). Responsible for project tracking Provide support to local medical advisors/medical affairs groups in the development of local studies,ensuring full alignment with both Regional&Global strategy Contribute to multidisciplinary(medical-marketing-market access) task forces to support continuous improvement,ensuring appropriate execution of key medical activities(MPH,advisory boards, etc.) Provide clinical training to both new local medical advisors and/or local marketing colleagues Coach regional xfunctional teams (marketing, medical and MAx) & countries Medical Affairs members. Participate as extended member in the IGT;liaise with the ICT,CTT&GBMD for participation of the assigned region in development trials (includes leading the pre-allocation process)
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
The appropriate candidate will be a MD with experience in oncology/hematology. Fluent English (oral and written). Any other language is a plus MD with a minimum of 3+ years of oncology/hematology or immunotherapy clinical research experience in pharma. Must have significant, highly relevant experience in hematology and oncology or immunotherapy clinical trial & clinical operations.
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