- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program . This Clinical Science (CS) ... will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global...disease area and compound/Drug. May serve as speaker for program / franchise medical/scientific training - Guide the Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …accountability for operational study-level timeline, cost, and quality deliverables.Lead the development of the clinical study plan including critical path ... and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the...is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the… 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 ... drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program ...+ 6 years OR PhD/PharmD + 2 years Pharmaceutical and/or- clinical drug development experience. Degree in life… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , ... 1-3 clinical trials at the study and program level. Responsible for clinical program...the associated budget meet the needs of the overall development plan agreed to by the Global Project Team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development , maintenance, and ... pipeline.Proactively identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial lifecycle.Standardize… more
- Merck & Co. (North Wales, PA)
- …is business savvy and results-oriented. Expert knowledge and understanding of Clinical Development processes and procedures. Master project management and ... Job DescriptionPosition Description: Director , Global Clinical Trial Operations (GCTO)...Operations (GCTO). The role will also contribute to the Program Management Office (PMO) tracking and reporting, change management… 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, ... representative: Creates early development plan and contributes to overall development Strategy; Develops program biomarker strategy; Achieves endorsement for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an advanced degree required.6-9 years of experience with a bachelor's degree required. Clinical development or post-marketing experience to be able to apprehend ... as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, in order to proactively perform safety surveillance and… 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 ... matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as… more
- Insmed Incorporated (San Diego, CA)
- …for the development of, and the oversight for execution of clinical studies milestones to support company budgets, and quality standards.Ensure the clinical ... lists.OverviewThe primary responsibilities are to manage all aspects of clinical operations including study planning, financial oversight, project deadlines and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …that support the clinical development and regulatory requirements of a clinical program . The Director will provide high level strategic input into ... NJ. We support programs from early research through late-stage clinical development . We are building for the...development plans, study designs, and regulatory submissions. The Director will provide direction and mentoring to other members… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Oversees early-stage trials, such as global clinical development program for multiple product candidates with one ... interactions with senior management of CRO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission documents;… more
- Merck & Co. (Rahway, NJ)
- …control and risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ... cross-functional Device Working Group to ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and… more
- Tris Pharma (Monmouth Junction, NJ)
- … Director provides leadership, direction and medical expertise for company’s clinical development programs specifically focused on the treatment of Pain. ... development /delivery and execution oversight of the Pain clinical development strategy and clinical ...programs and assists, as appropriate, in other therapeutic area program development (ie, substance use disorders, ADHD,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …required along with a minimum of 5 years of team leadership in clinical development /trials Experience leading cross-functional teams in the execution of ... 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with the VP Medical/Scientific Development , Clinical Operations, Non- Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs ... develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support...the VP Medical/Scientific Development as the US/international clinical lead for DCR-PHXC program to both… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy, design, ... medical guidance for coding of AEs, medical history, and medications when needed- Clinical Development Expertise Strategy- In collaboration with the Global … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages ... these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director... and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader… 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...responsible for administrative and management support of field-based FMA Program at Novo Nordisk Inc (NNI). Accountable for ensuring… more
- Merck & Co. (Rahway, NJ)
- …DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... will be responsible for resourcing planning, risk assessment strategies, talent development , and partnering to build a culture of innovation and inclusion.-The… more
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