- Merck & Co. (San Diego, CA)
- …planning, feasibility, and execution of a clinical trial.-This may include:May serve as the clinical trial team lead -May lead team in key ... team , country teams, vendors, committees) in support of clinical study objectives.-Accountable for managing any study specific partners and/or vendors.-Core… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational quality ... quality management and inspection management activities.The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to execute the strategy through collaboration and transparent communication.Member of the Clinical Operational leadership team and global clinical operations ... of the Study Management Group Heads and/or Vice President, Clinical Development Operations.Contribute to and/or lead in...Vice President, Clinical Development Operations.Contribute to and/or lead in the development and growth of the Study… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Clinical Quality Assurance Professional (QAP) position is responsible for design, delivery and execution ... of the global Clinical Quality Assurance (CQA) strategy including audit and inspection...plan.Champion CQA's mission of 'Quality as enabler of business'; lead global initiatives for continuous improvement.Trend and leverage internal… more
- Merck & Co. (Rahway, NJ)
- …This may include:Serving as the lead clinical scientist on the clinical trial team .Leading medical monitoring team in review and interpretation of ... Job DescriptionOphthalmology Clinical Scientist:Job SummaryThis position leads the scientific planning...scientific acumen as part of a global, cross functional team .Job ResponsibilitiesResponsible for leading specific aspects of clinical… more
- Merck & Co. (North Wales, PA)
- …pipeline candidates and licensed products. The Section Head manages Product Development Team (PDT) leaders and clinical directors responsible for the design ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Pediatrics will focus on driving strategy,...the Therapeutic Area. The incumbent will be expected to lead multiple programs that are in various stages of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated ... function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory,...Responsibilities:Depending on the status of development of the compound, lead and medical-scientifically direct a team of… 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 ... do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the… more
- Merck & Co. (Rahway, NJ)
- …projects, and provide guidance and training to operationalize the GMP operations and staff. Lead team and coordination efforts with colleagues across the local ... Job DescriptionApplications are sought for a Process Engineering Lead position in o ur Reseach & Development...will support GMP capability build for the production of clinical supplies of bulk biologic drug substance at a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific conferences. Lead the Translational Subteam within the Global Project Team for the drug program. Present as needed at internal and external meetings. ... goals and enumerate key scientific questions that will drive clinical development decision-making. In doing so, he or she...or she will align closely with the Global Project Team and Global Team Leader as well… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of multiple projects ... from our therapeutics. Responsibilities: Acts as CDx representative to the Global Project Team (GPT) for any projects that definitively require a CDx for drug… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. ... reporting to the QA Investigation Supervisor within the Raritan Investigation Excellence Team . The QA Investigations Lead is responsible for providing quality… more
- Merck & Co. (Durham, NC)
- …are seeking an Assoc. Director to join our Live Virus Vaccine (LVV) team . The successful candidate will provide technical leadership and support for LVV franchises, ... Wilson, NC; and Burgwedel, Germany. The successful candidate will partner with the team Technical Product Leader as well as site Technical Operations and other key… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role ... within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment....a portfolio of ongoing projects.Ability to work with and lead others in a team environment.Experience developing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …seeking Manufacturing Lead Operator as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position is responsible for performing ... 2nd Shift (12pm-8:30pm)Key Responsibilities Be part of the manufacturing operations team responsible for production of autologous CAR-T products for clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Area leads, RD clinical leads, biostatistics and Joint Publications Team members on publication activities- Lead study publication committee discussions, ... quality and timeline of vendor work- Collaborate with study clinical or medical lead and biostats to...acts as delegate- Align with the GMA Oncology Publications Lead and respective team members to ensure… more
- Merck & Co. (Rahway, NJ)
- …substantially to and is a valued co-strategist on the Global Franchise Team and assigned Product Development (Sub-) Teams. Contributes to Life Cycle Management ... close collaboration and alignment with the Value and Implementation lead . Support the Regional Directors Medical Affairs and other...asset management issues and is part of the V&I team that works in close alignment with the Assets… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Continuous Improvement: Lead effective communication efforts within the Medical Affairs team , ensuring collaboration with other GxP QA functions (eg, GMP/IMP QA, ... ensure high data quality, proactively identifying and resolving issues throughout the clinical trial process. Customer Focus / Stakeholder:Engagement Lead the… more
- Insmed Incorporated (San Diego, CA)
- …do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the ... Science's Top EmployerInsmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science… more
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