- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head ... (v) encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management , and other key… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Senior Director , GCTO Project Management Office will report to the Executive Director , Head of the GCTO Project Management Office ... :- Bachelor's Degree with at least fifteen (15) years of pharmaceutical, clinical drug development, project management and/or medical field experience. Or… more
- Merck & Co. (North Wales, PA)
- …of clinical data/medical protocol deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members ... Summary This position drives scientific planning, strategy and execution of Phase 1-4 clinical studies. Under the direction of the Program Lead, you will collaborate… more
- Merck & Co. (Rahway, NJ)
- …designed clinical trials is critical to drug development.The Associate Director , Clinical Trials Communications role within our Research & Development ... role in a fast-paced matrixed environment. Preferred Experience & Skills: Clinical trial communications experience Budget and agency management experience.… more
- Eisai, Inc (NJ)
- …this is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to ... Essential Functions Oversee outsourcing requirements for phase I-IV global clinical trials including functional services.Accountable for vendor management ;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management , and outside vendors.ResponsibilitiesResponsible for all aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug development ... drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology) studies, support Phase 2/3 studies, represent function on study… 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...team members, and to a limited extent with senior management , and outside vendors; works independently for all phases… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global head of regulated bioanalysis will also form strategic internal (DMPRL, Clinical Operations, Data Management , Scientific Operations etc) and external ... position has extensive knowledge of regulated BA, DMPK, biological sciences, clinical pharmacology, BA strategic planning, regulatory guidance, and in-licensing and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior leadership ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective;… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development. Internal relationships include working ... with Headquarters, NA CMR including Clinical Trial Management , Medical Affairs, Regulatory Affairs and other NNI skill areas. External relationships include… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …components of a large-scale global clinical program using strong clinical project and program management , leadership, decision-making ability, people ... of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical … more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role in working ... a plusWorking knowledge of Good Clinical Practices, scientific and clinical methodology, protocol design, project management and regulatory requirements for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 ... , and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management , important… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders. Summary This position is responsible for providing project management , drug development expertise to Global Project Teams including strategic ... partnering with the Global Team leader as the Project Management lead on drug development projects. This position can...these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Director , Global Market Access, Immunology T he Director , Global Market Access, Immunology will play a leadership role in ... strategy for assets within our Immunology portfolio. In this role, the Director will lead the development and execution of global market access strategy,… more
- Merck & Co. (Los Angeles, CA)
- …in the greater Los Angeles Metro area. Role SummaryThe Regional Medical Scientific Director is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease ... questions about Company products. The work of an Regional Medical Scientific Director is aligned to: Scientific Exchange, Research, Scientific Congress Support, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management , is accountable for the end-to-end ... and SDTM and industry standard data collection practices preferred- 7+ years Clinical data management experience in a medical device, pharmaceutical company,… more
- Merck & Co. (Rahway, NJ)
- …understand our customers' needs and provide solutions to meet their needs.The Director , Market Access Oncology (Hematology) will be accountablefor the launch and ... life cycle management for our in-line assets in Hematology.In this capacity,...will work closely with value and Implementation teams under clinical development -to ensure all clinical trials… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development team based in ... therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo CAR-T cell therapy...to drive the successful translation of preclinical findings into clinical applications. Your expertise will be critical in advancing… more
