- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the ... ( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member ... with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to the CSL and Medical… more
- Merck & Co. (Rahway, NJ)
- …and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead , Oncology Global Clinical Development, ... the field of breast cancer. The Executive Director, PDT lead will manage the entire cycle of clinical...as well as the ability to function in a team environment, are essential.- Preferred Experience and Skills: Board… more
- Formation Bio (New York, NY)
- …time, and in compliance with all regulatory requirements. The Director will manage a team of Clinical Trial Managers (CTMs) and Clinical Research Associates ... of clinical studies. Provide leadership, direction, and oversight to the clinical trial management team , ensuring alignment with organizational goals and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standards. The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd Party Vendor Management and ... accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study...solutions, or bring to the attention of the operations lead of study team lead .… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders.SummaryThe Director, Clinical Safety, will be a product safety lead or part of a product safety team , and be responsible for ... this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …includes individual studies as well as programs or franchises.When sitting on a study team , lead the study team to develop a cross-functional, integrated ... needs of the overall development plan agreed to by the Global Project Team (GPT). Lead site selection and site qualification discussions, kick-off meetings and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... 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. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... lead the development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in… more
- Merck & Co. (Rahway, NJ)
- …development, and validationSelf-motivated with ability to work independentlyProven ability to lead team members of diverse skill sets and backgroundsStrong ... to ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and other key Ofunctions. Lead the Device… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Merck & Co. (Rahway, NJ)
- …(SMAR&D) group has an exciting opportunity for a director role as Strategic Operations Lead based in Rahway, NJ. As the Strategic Operations Lead within the ... you will drive the strategy and logistics for the team responsible for analytical release of raw materials, package...release of raw materials, package components, medical device components, clinical drug substance, and clinical drug product… more
- Merck & Co. (Rahway, NJ)
- …Area and strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.- The AVP provides strategic oversight for the early ... clinical space, determining and implementing the initial ...of Translational Medicine, and sits on the T-Med leadership team . The leader must have scientific excellence in Translational… more
- Formation Bio (New York, NY)
- …improve efficiency and increase the probability of success.Responsibilities Strategic Leadership: Lead and develop the Biostatistics team , fostering a ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Merck & Co. (Rahway, NJ)
- …(INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership. Lead / Support clinical supplies production with respect to device ... DescriptionJob Description Are you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs activities including strategy, communications, and medical affairs directed clinical activities across the oncology portfolio. The position has leadership ... Medical Affairs personnel working on Oncology products that can range from late clinical phases through launch and post-approval. In partnership with the New Product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and ensure delivery of RBQM CSM Training with Learning and Development team members. Lead development and implementation of process improvement initiatives ... a Quality by Design (QbD) and Risk-Based Quality Management (RBQM) approach to clinical trial conduct. Major focus is on operations concerning risk control and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external data acquisition and ... validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
