- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management meetings on behalf of the Study Management Group Heads and/or Vice President, Clinical Development Operations.Contribute to and/or lead in the ... programs, including those involving co- development (Alliance) partners. The Early Development (ED) Asset Lead will provide operational expertise for early… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Job Summary: The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated project/product risk management ... a key member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes ... 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development . preferredOncology experience… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development , Pediatrics will focus on driving strategy, development , and ... the Therapeutic Area. The incumbent will be expected to lead multiple programs that are in various stages of...development therefore requiring someone who has late vaccine clinical development and lifecycle management experience.The AVP… more
- Merck & Co. (Rahway, NJ)
- … development of quality plans to implement `quality by design` within clinical development programs, using a risk-based approach.The incumbent will be ... Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and...research division QA and acting as the link between Clinical Development , study teams, global business functions… more
- Merck & Co. (Rahway, NJ)
- …processes that facilitate our interactions with other stakeholder groups across the clinical development environment. The Global Process Stewards are responsible ... Case Development , Business Processes, Business Requirements Analysis, Change Management, Clinical Development , Clinical Supplies Management, Clinical … more
- Merck & Co. (Rahway, NJ)
- …for a Process Engineering Lead position in o ur Reseach & Development Division Biologics Process Research & Development (BPR&D). The incumbent will support ... generation technologies to keep our company at the forefront of innovation in development and clinical manufacturing of biologics. Over time the incumbent will… more
- Merck & Co. (Rahway, NJ)
- …/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical ... clinical data/medical protocol deviations in collaborations with the Clinical Director.Other responsibilities include:Collaborating cross-functionally in the development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …candidate will set goals and enumerate key scientific questions that will drive clinical development decision-making. In doing so, he or she will align ... plan documents, biomarker statistical analysis plans, and aid in the construction of clinical development plans, clinical protocols, and in the submission… more
- Insmed Incorporated (San Diego, CA)
- …compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on other related activities performed by ... and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Manufacturing Lead Operator as part of the Technical Operations team based in Raritan, ... operations team responsible for production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice… more
- Merck & Co. (Upper Gwynedd, PA)
- …manage through complexity and ambiguity along with competing priorities.Strong knowledge of Clinical Development / Operations and data.Experience with Python or ... experience in clinical operations and is responsible for leading the development of analysis, modeling, and visualizations in support of user needs across Global… more
- Merck & Co. (Durham, NC)
- …to strategic workstreams, knowledge sharing, and process improvement projects. Lead projects through all phases including project planning, project management ... forums and maintenance of product historical knowledge and best practices. Lead complex process investigations, including multi-site coordination and technical… more
- Genmab (NJ)
- …Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as compound lead , primarily up until proof of ... concept, and/or as trial responsible statistician.Responsibilities:Compound/Indication LevelAct as lead and main point of contact related to Statistics for… 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 ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners,...patients faster and more efficiently. About the PositionAs a Lead Product Manager, you will help execute on our… more
- Merck & Co. (Rahway, NJ)
- …responsibilities are as follows:Oversee the outsourcing and coordination of formulation development and clinical manufacturing at Contract Research Organization ... Job DescriptionOur company's Pharmaceutical Sciences and Clinical Supply (PSCS) organization translates molecules to medicines, working from the discovery interface… more
- Merck & Co. (Rahway, NJ)
- …is expected to be experienced in mammalian cell culture or purification process development , tech transfer of clinical or/and commercial processes, and pertinent ... talent development skills. Extensive experience as a drug substance lead for biologics pipeline programs. Strong capability in managing evolving timelines,… more
- Merck & Co. (Rahway, NJ)
- …Molecular Biomarkers is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases ... of clinical development at our company's Research Laboratories....of scientific contributions to the scientific community.Demonstrated ability to lead and manage projects in a fast-paced environment.Ability to… more
- Merck & Co. (South San Francisco, CA)
- …and therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical development plans for ... clinical biomarker platforms. Development and execution of the early clinical development strategy for novel therapy/Immunology programs from Preclinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(QRBs).Collaborate with business process owners to monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and ... expertise in the involvement of regulated activities for medical affairs, or clinical development . requiredMust possess a solid understanding of global health… more
