- Insmed Incorporated (Bridgewater, NJ)
- …Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role ... in working with the team to execute the global clinical development plans of brensocatib for the HSindication. Tasks include preparing clinical documents (eg… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …activities in the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development . Internal relationships include ... and project strategic documents, including NNI Evidence Generation Plans and Product Development Plans Clinical study management: Provide regional medical &… more
- Volunteers of America Ohio-Indiana (Columbus, OH)
- …equitable solutions to address root cause issues by incorporating an equity framework in their daily work. We are committed to continuous personal DEI development . ... VOAOHIN is dedicated to helping those in need rebuild their lives and reach their full potential. As a Multi-State organization, we have over 1000 committed and caring/compassionate employees working in multiple impact areas. Volunteers of America Ohio &… more
- Merck & Co. (Rahway, NJ)
- …completion of carefully designed clinical trials is critical to drug development .The Associate Director , Clinical Trials Communications role within our ... enterprise-wide clinical trials communications strategy which includes the following:Amplify clinical trial key messages by managing the development of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , ... research areas centered around rare diseases and immune disorders.SummarySenior clinical operational leader accountable for operational planning and execution of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other ... well as other research areas centered around rare diseases and immune disorders. Summary The Director , Clinical Safety, will be a product safety lead or part of… more
- Merck & Co. (Rahway, NJ)
- …priority programs and studies.Adhere to company standards and Research Laboratory/Global Clinical Development (GCD) and GCTO goals, initiatives and ... the goals, purpose and mission of our company's Research Labs, Global Clinical Development (GCD) and GCTO.Positive proven success in people management.Strategic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key ... Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- OverviewUnder the direction of the Senior Director of Non- Clinical Drug Development and with limited direction, the Business Development Manager will be ... works to expand its efforts as a Contract Research Organization.The Business Development Manager will work to uncover and cultivate business opportunities to… more
- Eisai, Inc (NJ)
- …a good understanding of other IT systems for contract management and clinical development .#LI-TS1Eisai Salary Transparency Language:The base salary range for the ... and oncology, with a strong emphasis on research and development . Our history includes the development of...want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …establishing area-relevant standards, (v) encouraging innovation.Build strong relationships with clinical development , clinical sciences, regulatory, ... and empowers colleagues, influence stakeholders inside and outside of GCO to accelerate clinical development timelines and to create value for patients and the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration. ... Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology ... The primary responsibilities of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical … more
- Merck & Co. (North Wales, PA)
- …Asset team. Our Company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the ... regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior Director , Executive Director… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of this position is to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry best practices), ensures ... head of regulated bioanalysis will also form strategic internal (DMPRL, Clinical Operations, Data Management, Scientific Operations etc) and external partnerships to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Merck & Co. (North Wales, PA)
- …Advanced degree (eg, MS, MBA, Ph.D., PharmD) preferredExperience and knowledge of clinical drug development strongly preferred; including the different phases of ... Job DescriptionThe drug development Project Manager is part of Global Project...organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …GCO Leadership, GCO Study Management, CROs, Procurement, Legal, Compliance, Finance, Clinical Development , Global Project Management, and Functional Quality ... Financial Reporting & Strategy position provides leadership in strategy and process development for Global Clinical Operations (GCO) to ensure the implementation… more
