- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical trials from protocol finalization through closeout. Relationships Reports to: Director , Clinical Operations . Essential Functions Collaborate with ... Manager (CPM). This is a unique opportunity to work in a growing Clinical Operations Department that manages multiple early and late stage clinical programs.… 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
- Merck & Co. (Boston, MA)
- …opportunity for a physician-scientist to join our group as a- Principal Scientist ( Clinical Director ) in Translational Medicine/Early Clinical Development in ... drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations ) for the design and execution of early clinical… more
- Insmed Incorporated (San Diego, CA)
- … clinical development team, partnering closely with heads of clinical operations , toxicology, regulatory affairs, commercial, pharmacovigilance, clinical ... clinical studies.Medical monitoring, coding, and data cleaning in collaboration with Clinical Operations .Ensure the medical integrity of clinical study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... medical topics, and supports PV Operations ' medical review function. This position supports a senior...board eligibility preferred Experience Qualifications1 or More Years of clinical experience preferred Daiichi Sankyo, Inc. is an equal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to: VP, Medical & Science. Work with the VP Medical/Scientific Development, Clinical Operations , Non- Clinical Research, Medical Writing, Program Management, ... and international regulatory requirements Work with the VP Medical/Scientific Development, Clinical Operations , Non- Clinical Research, Medical Writing,… more
- Merck & Co. (Rahway, NJ)
- …Molecule Analytical Research and Development (SMAR&D) group has an exciting opportunity for a Director role as GxP Strategic Lead based in Rahway, NJ. Join us and ... of analytical methodologies to characterize and release raw materials, package components, clinical drug substance, and clinical drug product for our small… more
- Merck & Co. (Rahway, NJ)
- …8 years working on a clinical trial team or has worked in a clinical operations group in a cross-functional manner and understands the various steps in the ... how metrics can be used to drive strategic directives, clinical operations and/or process improvement initiatives.#EligibleforERP ResearchandDevelopmentGCTO… more
- Merck & Co. (Rahway, NJ)
- …approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will ... integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory, Operations , Non- clinical , Clinical , and other functional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Reporting to the head of Clinical , medical, Regulatory (CMR) Business Operations , the Associate Director (AD) is responsible for structuring facilitating and ... Minimum 10 years of experience with Supplier Management, Research Administration, Grant Operations , Grant Management, clinical trial management, or a similar… more
- Merck & Co. (Boston, MA)
- …and retention efforts to achieve study milestones.Upon request from Global Clinical Trial Operations (GCTO).Recommends study sites and identifies potential ... in the assigned territory (Boston area).Role SummaryThe Oncology Regional Medical Scientific Director - Head & Neck Cancers/Melanoma is a credentialed (ie, PhD,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe US Director of Precision Medicine will lead the national lab strategy, diagnostic collaboration, and partnerships across the US market. This role ... and commercial lab customers, and ensuring the alignment of precision medicine into clinical practice.- This is an individual contributor role that will sit on the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are currently recruiting for a Global Marketing Director for metastatic lung cancers. Our Marketing team is passionate about bringing our medicines ... Business Development & Licensing, market analytics, international and domestic operations , legal, scientific communications, professional education, training and development,… more
- Genmab (Plainsboro, NJ)
- …for coordinating sourcing for new trials to ensure efficient and effective trial operations .Point of Contact for Global Clinical Trial Managers: Act as the ... essential to fulfilling our purpose.The Role & DepartmentThe Associate Director , Vendor Management, will play a pivotal role in...a pivotal role in managing the relationships with the clinical vendors as well as coordinate and manage outsourcing… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Sr. Director of Technical Transfer is responsible for activities related to technology transfer from external and internal customers. This ... aspects of technical transfer including analytical transfer, development studies, clinical supplies, manufacturing scale up, equipment and process qualification,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... mentors and may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads ... and Regulatory Liaisons to ensure successful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globallyFor late-stage… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations , Regulatory Affairs, Data Management, Biostatistics, Non- ... and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct… more
- Merck & Co. (San Diego, CA)
- …public data resources, to generate novel CDx models that can be deployed in clinical trials. You will also support preparation of regulatory documents in support of ... clinical trials.- In addition, you will be the site...San Diego and will have oversight of the biospecimen operations and biobanking. You will serve as a strategic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of the Quality team ... based in Raritan, NJ. Role OverviewThe Associate Director of Quality Project Management and Strategy role is...within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.… more
