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The MDMP interacts and partners with marketed products R&D function leads (regulatory affairs, pharmacovigilance, global development operations and project management) to set R&D strategy and prioritize R&D functional support for assigned MP portfolio.
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This position reports to VP, CDMA with a dotted line reporting relationship to the CSO. The Senior Director CDMA will interact with internal colleagues in Research and Development (Clinical Development & Medical Affairs, Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs, Pharmacovigilance) Strategy/Portfolio Management, Global Device Engineering, Commercial and Operations functions.
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Internally, you will collaborate closely with the global medical affairs team, development and project teams, as well as our commercial, HEOR and development teams, to align with disease and brand priorities.
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Oversee the establishment and execution of design and development plans for medical and non-medical solutions, and for the development of electronic accessories in the medical environment while accountable for the portfolio of project release success.
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Medical Director / Senior Medical Director, APOL1 Project Team Leader. Develop and integrate timelines and budgets for nonclinical and clinical activities with overall company timelines and goals, in close coordination with project management, CMC, nonclinical development, regulatory affairs, and other stakeholders.
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He/She will work closely with the clinical project scientist team and Clinical Leader in Late Development, in collaboration with other functional disciplines, including GCO, Data Management, Statistics, Regulatory, QMMC, and GMS to ensure flawless and integrated execution of study start-up planning, oversight, and reporting of clinical studies in Oncology.
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Janssen Research and Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Medical Director/Senior Medical Director, Clinical Research - Solid Tumor.
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O Working closely with the colleague study responsible physicians and clinical project scientists in collaboration with GCO and GMS to ensure comprehensive medical monitoring, thorough and timely responses to address site issues and eligibility questions, and detailed, real time review of serious adverse events and deaths.
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O Work closely with clinical scientists and data management to support medical review and data query resolution. Work closely with functional partners (Data Management, Biostatistics, Regulatory, GCO, QMMC, GMS) to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s) in late development in close collaboration with key functional stakeholders.
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May interact with medical consultants in concert with senior clinical staff, in conducting IDMC and Investigator meetings as well as Advisory Boards. The successful person in this role will provide mentoring and support to the clinical project scientists on the team and will work with PMO, Finance, and the Clinical Leader to assure appropriate resourcing of clinical studies.
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O Work with the Clinical Leader, with Data Management and with Statistics on analysis of study results and completion of study reports. o Work closely with Clinical Leader, Project Physician, Regulatory and GCO to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion.
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O Collaborate with the Clinical Leader, Clinical Project Scientists and Procurement on key study design elements including assessment of complexity and cost of protocol-required evaluations. o Work closely with Quality Management & Quality Assurance to review audit findings and implement effective corrective action plans.
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Lead the project scientists, ensuring appropriate training, mentoring, and supervision across the assigned study/studies within the clinical development program. o Working in partnership with colleague study responsible physicians and clinical project scientists to ensure development of high quality study protocols including use of consistent processes/standards across studies.
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Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.
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May review/co-author medical publications emerging from clinical trial results. Experience in protocol development, medical review, oversight of study conduct, running trials, data quality and safety are strongly preferred.
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project management jobs Title: senior director medical
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