- Daiichi Sankyo, Inc. (Bernards, NJ)
- …coordinated and aligned strategy.Responsibilities:Operational Strategy and Oversight:Align with the Senior Director , Global Clinical Operations on plans for ... SOPs. The Director will ensure the Senior Director , Clinical Operations (Asset Lead) is fully...This will include providing innovative strategies to continuously improve Global Clinical Operations quality and metrics. IT… more
- Merck & Co. (Upper Gwynedd, PA)
- …Our Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire cycle of ... regulatory affairs, statistics, and manufacturing to manage clinical development projects; and Assist the Executive Director /AVP in ensuring… more
- Eisai, Inc (Nutley, NJ)
- … Pharmacology will be relied upon to act independently, within a highly-matrixed clinical development organization and must have the experience and conviction to ... your profile, we want to hear from you. The Director , Clinical Pharmacology actively contributes to multi-disciplinary...to established design principals and integrates them into the Clinical Development Plan (CDP) and Drug … more
- Eisai, Inc (Nutley, NJ)
- …(QAP) position is responsible for design, delivery and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection ... Direct and drive design, delivery, and execution of the global Clinical Quality Assurance (CQA) strategy for...or Master's degree with 15 or more years significant clinical pharmaceutical experience (ie, clinical development… more
- Eisai, Inc (Baltimore, MD)
- …and internal process audits Facilitate Sponsor health authority inspections of global clinical facilities and study sites Continuously drive innovation ... and oncology, with a strong emphasis on research and development . Our history includes the development of...is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across our company ... globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...immune disorders. Job Summary: The Sr. Director , Clinical Safety MD, will lead the development … more
- Insmed Incorporated (NJ)
- …and cross functional teams. This individual will provide scientific support to clinical development and operations, regulatory and quality assurance teams, as ... objectives: Develop, review, and revise departmental and corporate SOPs and processes.Provide clinical development and technical expertise in support of due… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the development of the GMP Compliance program related to clinical / commercial stage and manufacturing.Support Legend's regulatory program and monitor the ... Legend Biotech is a global biotechnology company dedicated to treating, and one...of regulatory guidelines across all manufacturing areas, supporting both clinical and commercial sites. This individual will be a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...The Position The position serves as the lead of Clinical Data Science & Evidence (CDSE) operations. In their… more
- Jazz Pharmaceuticals (Atherton, CA)
- …HEOR data, phase IV studies. Collaborate with cross-functional teams including clinical operations, clinical development , data science and global medical ... development and implementation of AI/ML/GenAI solutions to optimize clinical trial operations, including such areas as patient recruitment, patient retention,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the involvement of regulated activities for medical affairs, or clinical development . requiredMust possess a solid understanding of global health authority ... (QRBs).Collaborate with business process owners to monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the physiology, pathophysiology and mechanism of action of Novo Nordisk compounds. The Director works closely with Research & Development teams to translate the ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...US Operations. This individual will also work closely with global colleagues in Research & Development The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Director Global Medical Affairs Oncology (GMA), ADC, under the direction ... of the Senior Director , GMA Oncology ADC ( Global Medical Affairs...projects within a specific compound or indication.Responsibilities- Leads the development of the Global Medical Affairs strategy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … global pharmacovigilance standards Physical Requirements 0-10% travel required. Development of People Supervisory. Verbiage below applies only to Supervisory ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Merck & Co. (North Wales, PA)
- …position is responsible for the formulation and execution of automation strategy in Global Clinical Trial Operations and all the support activities within their ... functional area. This includes working with stakeholders across Global Clinical Trial Operations (GCTO)and other relevant teams, driving the strategy from… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and risk management. Responsibilities Leadership, Direction, and Strategy: - In collaboration with Clinical Development and Clinical Operations as well as ... around rare diseases and immune disorders. Summary The Executive Director , Data Management (Head of Global Data...is responsible for performance of the function and the development of group members and also monitors trends in… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in Philadelphia, PA or Somerset, NJ. Role OverviewWe ... Legend Biotech is a global biotechnology company dedicated to treating, and one...strategy from early research through IND-enabling studies and into clinical development , ensuring regulatory compliance and scientific… more
- Merck & Co. (Rahway, NJ)
- …strategy of partner scientific areas in conjunction with functional area and clinical development leadership.- For example, the Enabling Technologies team ... Job DescriptionOur Business Development & Licensing organization is a global...that grow our portfolio in meaningful ways. - The Director , Business Development & Licensing - Enabling… more
- Insmed Incorporated (San Diego, CA)
- …teams (CMC, clinical and project teams)Ability and experience in the development and execution of Global regulatory strategyIn-depth knowledge and direct ... assessments to cross-functional teams and senior leadership, as neededCollaborate with Clinical Development , Clinical Operations, CMC, QA/QC, Nonclinical,… more
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