- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director , Technical Operations within Global Clinical Supply (GCS) is responsible for technical leadership in support of GCS global ... equipment-based challenges when required.- The technical lead may also manage global infrastructure projects to establish, upgrade, and improve the GCS packaging,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization within o ur Research & Development Division manages the end-to-end clinical supply chain for ... the Company's portfolio (300+ Phase I-IV Clinical Trials, 200+ Investigator Initiated Studies and 200+ External...regulations, company policies and standard operating procedures. The Senior Director , Global Operations Planning, is a strategic… more
- Insmed Incorporated (NJ)
- …of science, we're in. Are you?About the Role:We're looking for an Executive Medical Director of Ophthalmology, Clinical Development to help us expand what's ... serious diseases. Reporting to the VP, Clinical Development - Gene Therapy, the Executive Director ...MD or DO preferred, along with 10 years of global experience in ophthalmology clinical development… 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...affairs projects within a specific compound or indication.ResponsibilitiesLeads the development of the Global Medical Affairs strategy… more
- Insmed Incorporated (NJ)
- …a professional manner to executive audiences including attendance at requested meetings (ie, Global Clinical Team, Global Project Team, etc.)Who You ... Represents Clinical Operations in a range of cross-functional groups, global functional committee(s) and initiatives intended to enhance function and company… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cross- functionally and in global teams.Strong Industry Network in clinical development . Knowledge and understanding of cultural differences and diversity ... Strategy and Operations to ensure alignment and execution of global initiatives. The incumbent will oversee the development... global initiatives. The incumbent will oversee the development and promotion of the 6th Mid-Term Strategy for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator ... Director will also assist the Senior Medical Director in the development and execution of... Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director ,… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Global Associate Director , will lead projects and contribute to the payer evidence strategy ... analytic background, desiring more exposure to reimbursement and value strategy development . Essential Functions Key deliverables development : Global economic… more
- Eisai, Inc (WA)
- …leader to shape and drive Clinical Data Science strategy across our global clinical development portfolio. This role ensures the rigorous application ... in clinical trials. Minimum 10 years of industry experience in clinical development , including Data Science and Biostatistics. Recognized thought leader in… 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...and immune disorders. Summary: The Senior Director , Clinical Safety, will lead the development and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …objectives are aligned and embedded in evidence generation, medical strategy, and clinical development plans, where appropriate. Gains strategic and planning ... areas centered around rare diseases and immune disorders. SummaryThe Executive Director , Global Oncology Medical Affairs, External Scientific Collaboration role… more
- Eisai, Inc (Nutley, NJ)
- …leadership for global outsourcing and vendor management activities within clinical development . This role is accountable for designing and executing ... along with a proven track record in inspection-facing roles and global regulatory compliance.Essential Functions Clinical Outsourcing Designs and executes… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. The Director of Clinical Outsourcing is responsible for leading the development and execution of outsourcing ... relationships, oversees qualification processes, and implements governance frameworks to support clinical development programs. Acting as a key liaison across… more
- Insmed Incorporated (NJ)
- …credentials and experience.What You'll Do: Lead development and execution of global regulatory strategies for clinical , pre- clinical , and lifecycle ... for assigned programs. This role will provide regulatory input to global cross-functional project teams throughout product development and submission… more
- Insmed Incorporated (San Diego, CA)
- …expand what's possible for patients with serious diseases. Reporting to the Executive Director , Clinical Development , you will support and work predominately ... we're in. Are you?About the Role:We're looking for a Director , Clinical Scientist for the Gene Therapy...will provide clinical and scientific support to clinical development and operations, regulatory, medical affairs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …establishment processes in collaboration with GMP Quality System function. Supports the development and implementation of key global /regional QA GMP Standards, ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Formation Bio (New York, NY)
- …for programs and clinical studies. Collaborate with cross-functional teams ( Clinical Development , Regulatory, Program Management, etc.) to shape and refine ... Clinical Development Plans, ensuring feasibility and operational... trials. In-depth knowledge of ICH-GCP, FDA regulations, and global clinical trial guidelines. Strong strategic thinking… more
- Insmed Incorporated (NJ)
- …plans, contingency strategies, and risk mitigation across global marketsSupport the development and monitoring of clinical supply budgets and global ... (primary/secondary), labeling, distribution, returns, reconciliation, destruction, and logistics for global clinical programsDefine and implement comprehensive sourcing… more
- Insmed Incorporated (NJ)
- …Medical Leadership, Medical Directors, Scientific Communications, Field Medical Excellence, Clinical Development , and Commercial Effectiveness to deliver high ... other, and for the future of science, we're in. Are you?About the Role:The Director , Global Medical Training Strategy will be responsible for developing the… more
