- Daiichi Sankyo, Inc. (Bernards, NJ)
- …accurate and complete study team list is maintained.In partnership with the lead physician, Clinical Scientist and all study team members, accountable ... (SDL) leads the cross functional core and extended clinical study team in end-to end delivery...insourcing. This includes global operational execution and delivery of clinical studies across multiple geographic regions, in… more
- Insmed Incorporated (NJ)
- …to ensure the effective and efficient execution of all operational aspects of clinical study planning, implementation, data delivery and reporting. Represents ... vendor management, GCP, etc.Develops operational strategies for implementation of clinical studies regionally/globally in conjunction with project teams… more
- Merck & Co. (Rahway, NJ)
- …of Clinical Scientists in the execution of clinical studies .Work closely with a cross-functional group of experts in commercialization, regulatory ... support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint… more
- Eisai, Inc (Nutley, NJ)
- …(DDP)Leads the development of Clinical Protocols to meet CDP objectives.Serves as Study Director/ Clinical Pharmacology Lead and drives the execution of ... study data.Implements strategies to identify, monitor and resolve clinical program/trial issues.Interprets study data and develops integrated summaries… more
- Merck & Co. (North Wales, PA)
- …biostatistical support for related drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical , Regulatory, Statistical Programming, ... assigned to a development project as neededLead biostatistics in early or late clinical development planning to ensure that study designs are consistent with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study document development ... a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of...studies (IIS) and may serve as deputy compound lead in Global IIS Review Committee meetings.Leads external medical… more
- Merck & Co. (Rahway, NJ)
- …internal teams and external partners, design non-interventional and data synthesis studies , author study protocols, develop measurement questionnaires, case ... value evidence teams in head & neck cancers and lead the execution of value evidence projects in head...in collaboration with internal teams, and provide input into clinical , payer/access, marketing and value evidence generation strategies and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Review and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator… more
- Genmab (NJ)
- …and decision‑making.Responsibilities:1. Portfolio and Strategic LeadershipServe as a portfolio‑level lead for external data quality and clinical data‑related ... improvement initiatives that enhance efficiency, consistency, and inspection readiness across Clinical Operations and Clinical Data Management. Lead the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve ... strong portfolio of medicines for cardiovascular diseases, under the Group 's 2025 Vision to become a "Global Pharma Innovator...Affairs committees as requested. Serves as US Medical Affairs Lead , to gain strategic and planning alignment across the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …critical evidence and educational gaps through targeted strategies (eg, scientific education, clinical studies ) to advance biomarker and CDx understanding and ... Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve ... to a strong portfolio of medicines for cardiovascular diseases, under the Group 's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage… more
- Merck & Co. (Rahway, NJ)
- …Operations Specialist (P1) - - Description- - The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking ... (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant under construction in Rahway, New Jersey. They… more
- Insmed Incorporated (NJ)
- …strategy, LCM/IIR Strategy, and the design and execution of Phase 4 company sponsored studies , including HEOR studies and registries. Lead and execute on ... and provide support to the processes related to Investigator Initiated Studies .Work collaboratively with key intra- and inter- departmental partners (Field Medical,… more
- CSL Behring (King Of Prussia, PA)
- …of Clinical Sciences and Medical Writing, Director Medical Writing Processes & Standards Group Lead , Clinical Scientist Leads, Global Clinical Leads ... Could you be our next Director, Medical Writing Resourcing Group Lead ? The job is in our...Development Medical Writing Deliverables, including Investigators Brochure (IB), the Clinical Study Outline, The Clinical … more
- Sanofi Group (Morristown, NJ)
- …individual will also serve as Study Medical Manager (SMM) for selected clinical studies . SMM principal duties and responsibilities include:** Study ... **Job Title:** Clinical Lead , Early Clinical ...Dose Escalation Meeting and document decision making (for First-in-Human studies ). + Review the Adverse Event reports. Study… more
- Sanofi Group (Cambridge, MA)
- …of vendors, Vendor Excellence SMEs, Clinical Operations Project Lead , Clinical Operations Study Lead , Procurement and other relevant departments. ... **Job Title:** Clinical Operations Vendor Category Lead , Digital...oversight, and clinical operations knowledge and managing clinical studies with strong project management skills.… more
- Takeda Pharmaceuticals (Boston, MA)
- …inspire you and empower you to shine? Join us as a Vice President , Global Clinical Lead - Solid Tumor in our Cambridge office. At Takeda, we are transforming ... mission. **OBJECTIVES** **:** Responsible for leading as the Global Clinical Lead a large solid tumor oncology...Plan (IGDP). Responsible for review of synopses, other relevant clinical study documents and critical Study… more
- Sanofi Group (Cambridge, MA)
- …is to: + Provide medical expertise in the Study team to conduct the clinical studies from early phases to LCM programs + Collaborate with other medical and ... ** Lead , Support and oversee the execution of clinical development and studies activities** + Collaborate...readiness and availability, and mandatory trainings linked to the clinical function + Lead the study… more
- Sanofi Group (Morristown, NJ)
- …possible for millions. The Senior Clinical Research Director (CRD) is an **expert clinical lead for one or several indications in the Development of an R&D ... to the cross functional project team to conduct the clinical studies from early phases to LCM... from early phases to LCM programs + Establish clinical development strategy and lead clinical… more
