- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team ... performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for...of 7 years of relevant experience requiredExperience: Experience in clinical operations methods and processes in industry… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global ... Clinical Study Start-Up activities for PV Safety Operations...where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong… 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
- Merck & Co. (Rockville, MD)
- …the company enterprise policy agenda.Responsibilities and activities of the Senior Director , Clinical Research Policyinclude:Leads and is responsible for the ... Company's Clinical Research Policy and Intelligence operations globally,Provides leadership and strategic direction to the Clinical Research Policy… 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. (Rahway, NJ)
- … Clinical Supply and Technology Innovation implementation into the pipeline.The Director Manufacturing Operations (m/f/d) leads an Operating Unit responsible ... and continuous manufacturing -with a Quality First, Safety Aways Mindset. -The Director Manufacturing Operations (m/f/d) leads teams responsible for Technology… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssoc. Director of Support Operations (m/f/d)The Biotech facility embeds the latest technologies into the early stage clinical pipeline, ... Phase Clinical Supply and Technology Innovation implementation into the pipeline.The Assoc. Director of Support Operations (m/f/d) will be a member of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …OED; considers relevant input and guidance to other areas within NACD including Operations Director and TA Heads Analyze And Anticipate Business Needs: Utilizes ... Collaboration: Responsible for implementation of best practices and standards for clinical operations , including sharing lessons learned. Partner closely with… 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
- Merck & Co. (North Wales, PA)
- …Oncology Translational Studies Program (OTSP)-research studies.-Upon request from Global Clinical Trial Operations (GCTO):-Identify barriers to patient ... Job DescriptionRole SummaryThe Regional Medical Scientific Director is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease expert who engages in… 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 ... ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department...serve to act as an advisor to North America Operations (NAO) CMR organization on all aspects of new… more
- Merck & Co. (Lower Gwynedd, PA)
- …Metabolism, and Bioanalytics (PDMB) Regulated Bioanalytics Department is seeking a Senior Director to lead the Regulated Robotics & LIMS team within the Exploratory ... IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data.… more
- Merck & Co. (Rahway, NJ)
- …complex biotherapeutics.The Director of Compliance, reporting to the Senior Director of GMP Operations , will oversee laboratory compliance across multiple ... Job Description Job Description: The GMP Operations branch of Biologics Analytical Research & Development (BAR&D) seeks a driven leader to advance and commercialize… more
- Merck & Co. (Rahway, NJ)
- …(eg INT, ADCs). The team member will partner closely with global marketing, operations , finance & enterprise strategy, and clinical & discovery to inform ... and provide transparency to all relevant stakeholders, including global marketing, operations , clinical teams, and governance committees.Required Knowledge and… more
- Merck & Co. (Lower Gwynedd, PA)
- Job DescriptionAbout Us: The Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab ... IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data.… 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
- Merck & Co. (North Wales, PA)
- …health authority regulated environment - Understanding of pharmacovigilance, medical affairs, clinical operations and product quality complaints processes and ... and integrity.-Collaborate with other departments: Collaborate with departments such as clinical , regulatory, and safety to ensure that PV processes are integrated… more
- Insmed Incorporated (New York, NY)
- …insights to Insmed.Support research and development programs as requested by R&D, Clinical Operations , and Medical Affairs Departments. This may include trial ... a local medical and scientific resource to Insmed for product planning, clinical insights, and intelligence. Capture, synthesize and deliver HCP derived scientific… 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
