- Novo Nordisk Inc. (Plainsboro, NJ)
- …working procedures, quality, and output. The Strategy Director serves as the clinical development strategy lead for pipeline projects. This role will ... including Clinical Development, Medical, & Regulatory Affairs (CMR), Commercial Strategy & Marketing, and the Global organization to drive strategic development… 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 ... for overseeing and managing various aspects of operational activities within Clinical Development & Operations (CDO). Takes ownership to deliver upon near… more
- Genmab (Plainsboro, NJ)
- …its own products across various markets within cancer treatment.We are now looking for a Clinical Project Lead (CPL) to join the team, who will be responsible ... the Clinical and Compound Development Plans developed by the CDT. Lead and coordinate cross functional Development Operations input and ensure unified… more
- Genmab (Plainsboro, NJ)
- …Medical Affairs Hematology Strategy will report to the Director, US Medical Affairs Hematology Strategy Lead . S/he will assist the strategy lead to ... requires being in Princeton, NJ 60% of the time.ResponsibilitiesPartner with the indication strategy team lead to delivering the US Medical Affairs strategic and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …SummaryThis position oversees and manages US Medical Affairs activities including strategy , communications, and medical affairs directed clinical activities ... working on Oncology products that can range from late clinical phases through launch and post-approval. In partnership with...New Product or Commercial Brand Teams, the Medical Affairs lead develops the medical/commercial strategy based on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …support to the CSL and Medical Monitor in the execution of Clinical Development functions. Responsibilities: Study Strategy : Drafts development plan under ... development of study design to meet study objectives, development of biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology… more
- 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
- Merck & Co. (Rahway, NJ)
- …Director, PDT Lead will manage the entire cycle of clinical development, including development strategy , study design, initiation, execution, monitoring, ... Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead , Oncology Global Clinical Development, has primary responsibility… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with DS standards. The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd Party Vendor Management and ... an Associate Director (or above) responsible for Operational Study Strategy . This position may require the Sr. CSM to...accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …leaders, advisory boards, industry councils and the broader medical community. Essential Functions Lead the clinical informatics team in the (CDSE) department of ... conferences, and courses Strategic: Primary ownership for the CMR Clinical Informatics Strategy Oversee and provide strategic guidance for all clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Clinical Development Expertise Strategy :In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... (LWT), in collaboration with the CDLContributes from a medical strategy standpoint to developing the Clinical Study...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will have the responsibility of managing multiple direct reports. Responsibilities:Operational Strategy :Align with the Head of Clinical Development Operations or ... compounds at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio...as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated… more
- Genmab (Plainsboro, NJ)
- …will represent CPQS in the Translational and Quantitative Sciences Leadership Team and lead strategic development of pre- clinical and clinical pharmacology ... requires being onsite 60% of the time in Princeton, NJResponsibilitiesBuild, oversee and lead delivery of pre- clinical and clinical pharmacology team across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy : Provides the ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Genmab (Plainsboro, NJ)
- …Project Lead activities, including contract and amendment reviews, country/site strategy , and vendor management. Lead cross-trial initiatives as needed, such ... best, and authentic is essential to fulfilling our purpose.Overview The Global Clinical Trial Manager, Team Manager (GCTM-TM) is responsible for line management of… more
- Genmab (Plainsboro, NJ)
- …60% of the time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy , Global Regulatory Affairs, the key responsibilities ... regulatory requirements for programs and products. Participate in regulatory sub-team, clinical management team, and labeling working group meetings, as required for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare 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 overall product safety strategy or specific areas of safety surveillance and risk management, and provide safety… more
- Merck & Co. (Rahway, NJ)
- …to ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and other key Ofunctions. Lead the Device ... IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership. Lead /support/oversee clinical supplies production with respect to device… 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 ... SMAR&D GxP Operations group, you will drive the strategy and logistics for the team responsible for analytical...release of raw materials, package components, medical device components, clinical drug substance, and clinical drug product… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Strategy & Rare Disease (STARS) organization drives the long-term strategic direction of Novo Nordisk Inc. (NNI)/North America Operations ... is to facilitate the development and to coordinate the execution of the long-term strategy , defining a sustainable business model in US beyond a 5-year time horizon.… more
