- Merck & Co. (Rahway, NJ)
- … development teams and the operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager ( Program CSPM) serves as the ... clinical and development related meetings.- Working independently, the Program CSPM designs strategic and operational plans for all...key partner organizations ( as a lead GCS Planning program representative ) such as clinical development,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsThe Quantitative Pharmacology and Pharmacometrics (QP2) department ... at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate Director … more
- Merck & Co. (Rahway, NJ)
- …decision-making at our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of ... pharmacometricians.The Director -Pharmacometrics will work with scientists within QP2 by proactively evaluating and incorporating one or more of the following… more
- Merck & Co. (Rahway, NJ)
- …drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a strong, ... to strengthen our pharmacometrics capabilities on a continuous basis. The Senior Director will be accountable for directing a team of pharmacometricians with diverse… more
- Merck & Co. (Rahway, NJ)
- …one or more V&I, Outcomes Research teams across the Oncology GI cancers program . Primary Responsibilities: Support value evidence teams in Oncology and contribute to ... access in collaboration with internal teams, and provide input into clinical , payer/access, marketing and value evidence generation strategies and programs.In… more
- Merck & Co. (Rahway, NJ)
- …risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ResponsibilitiesLead ... ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and other key Ofunctions.Lead the Device… more
- Merck & Co. (Rahway, NJ)
- …execute, design verification strategies for assigned drug-device combination product program (s) for successful clinical introduction(s) and commercial market(s) ... and execute design verification strategies that successfully supports the clinical instruction(s) and commercial market approval(s) of combination products.Principal… 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)
- …You will also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities will include:-Driving our company's Pipeline:-Leading ... process development.Defining and implementing end-to-end analytical control strategies for clinical supplies under good manufacturing practices (including method development… more
- Merck & Co. (Rahway, NJ)
- …Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving ... and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development.A… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study ... and leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program … 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 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. (Bernards, NJ)
- Director , Clinical Development Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network… 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 ... study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met...financial metrics on an ongoing basis to study and program teams. In collaboration with internal and external partners,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external data acquisition and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Access departments as needed Project management liaison: Assist in developing clinical program time lines, budgets, and strategies Other essentials: ... in the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development. Internal relationships include working… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …initiative in support of these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director , US Head GPM&L. ... execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high performing ...the project environment to address gaps that impact the program /project.Manages the planning and use of program /project… more
- Genmab (Plainsboro, NJ)
- …management and budget planningProven performance in earlier role/comparable roleGlobal clinical program level experience requiredExperience within the field ... program , ensuring performance and competency development.Collaborate with Global Clinical Trial Managers (GCTMs) on trial activities for assigned direct… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This… more
- Genmab (Plainsboro, NJ)
- …and dedicated Medical Director to be a part of our Global Clinical Development Team.The Medical Director will be accountable for the medical oversight ... of one or more clinical trials, medical review and communication of data, and...regulatory documents and presentations.Responsibilities: Lead the development of the program strategy for assigned trials/compounds and participate in the… more
