- 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 ... guidance for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical… more
- Merck & Co. (Rahway, NJ)
- …activities involving investigational compounds in Immunology. With a focus on late-stage development , the Executive Clinical Director will manage the ... the development of new compounds The Executive Clinical Director may: Oversee the clinical...area of responsibility. To accomplish these goals, the Senior Clinical Director may: Author detailed development… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director , Global Clinical Drug Supply to be part of Global ... at the forefront of bringing medicines to cancer patients and other serious diseases. Director , Global Clinical Drug Supply will work in partnership with several… more
- Merck & Co. (Rahway, NJ)
- …- The Senior Director will manage the entire cycle of clinical development , including study design, placement, monitoring, analysis, regulatory reporting, ... and publication. - Specifically, the Senior Director may be responsible for Evaluating pre- clinical ...and translational work for the purpose of generating early clinical development plan and Investigational new drug… more
- Tris Pharma (Monmouth Junction, NJ)
- …a leading privately-owned US biopharmaceutical company with a focus on development and commercialization of innovative medicines addressing unmet patient needs. We ... have an immediate opening for a Head, Medical Science Liaisons (MSLs) / Director , Medical Training for our Pain division. This is a field-based position that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Director , Clinical Informatics in the Clinical Data Science & Evidence (CDSE) ... department develops clinical and medical informatics software and system development with customers in collaboration with the research partnerships function of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Clinical Data Science & Evidence (CDSE) department of NNI focused on clinical informatics tools development to support the CMR organization. This individual ... will serve as a subject matter expect on clinical and medical informatics software and system development... clinical and medical informatics software and system development with customers in collaboration with the research partnerships… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …accountability for operational study-level timeline, cost, and quality deliverables.Lead the development of the clinical study plan including critical path ... is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the...and guide their direct reports in support of their development needs, ensure individual development plans are… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & ... Clinical Safety global business processes. This includes defining and...as our company's QA, GCD Standards, and Learning & Development . This collaboration is essential in developing and executing… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a ... single or multiple clinical trials from strategy outline through to CSR by...regulatory submissions, and recruitmentBudget and PlanningAssist in the initial development and management of the trial budgetPlan, implement, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferredDaiichi Sankyo, Inc. is an equal opportunity/affirmative action ... around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reward hard work and dedication with opportunities for continuous learning and personal development . Are you ready to maximize your potential with us? The Position ... in order to accomplish objectives. Relationships Reports to the Executive Director , Patient Support Solutions. Key internal relationships include brand marketing,… more
- Merck & Co. (Rahway, NJ)
- …out R&D activities partnering across the network to enable process and formulation development .- In this position the SMAR&D Director will set guidance, lead ... development of characterization methods to characterize and release clinical drug substance and product and their stability tests, raw materials/excipients,… more
- Daiichi Sankyo, Inc. (Bernards, 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
- 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...study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met… more
- Merck & Co. (Rahway, NJ)
- …help people with cancer across the globe.Working with ADT's, early- & late-stage clinical development teams, the BMx leads will develop asset-specific ... biomarker strategy by incorporating critical insight from discovery biology, clinical development , diagnostics, bioinformatics, molecular assay experts, QP2 and… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The Role & DepartmentThe Associate Director , Vendor Management, will play a pivotal role in managing the ... relationships with the clinical vendors as well as coordinate and manage outsourcing...Managers, Data Managers, Clinicians, vendors) to support the overall development strategyProficient in managing service agreements and vendor contracts.Where… more
- Merck & Co. (Rahway, NJ)
- …and ethical standards.-The Distinguished Scientist (Executive Director ) and Product Development Team (PDT) lead, Oncology Global Clinical Development , ... Job DescriptionOur Clinical Development teams manage studies to...will interact externally with key opinion leaders.-Specifically, the Executive Director , PDT lead may be responsible for:-Evaluating pre- clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of technical training across all CMR functions, and compliance across clinical development , medical, and regulatory roles/processes/SOPs Develop and implement ... development , effective execution of CMR role-specific/technical training (eg clinical trial-related, patient safety, therapeutic area leads, MSLs etc.) across… more
