- Daiichi Sankyo, Inc. (Bernards, NJ)
- …accountability for operational study-level timeline, cost, and quality deliverables.Lead the development of the clinical study plan including critical path ... and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the...is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Clinical Development Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... guidance for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical… more
- Insmed Incorporated (San Diego, CA)
- …Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the ... to lead clinical programs across different diseases and supervise the clinical development team. This individual will be the primary point person… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary The Hematology US Scientific Director , Medical Affairs (SDMA) is a regionally based position in our Company's Research Laboratories, US ... with organizational priorities. Along with the USMA Field Leaders (Executive Director (ED)/Associate Vice President (AV)), the SDMA is responsible for regional… more
- Merck & Co. (Lower Gwynedd, PA)
- …on development teams that collaborates with various vaccine development program leaders across our CompanyResolves complex technical, operational, ... systems, system validation, and execution of these in support of GLP and clinical development programsDeep understanding of statistical methods to analyze and… more
- Merck & Co. (Rahway, NJ)
- …driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will report ... development with exposure to all stages and aspects of development (pre- clinical , clinical , and commercial)Strong influencing and communication… 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 ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met… more
- Merck & Co. (North Wales, PA)
- …sites, and identify potential investigators to participate in phase II-IV clinical development programs-Address questions from investigators and provide ... development and active Company-Sponsored Trials and/or company Investigator-Sponsored Program (MISP)-and Oncology Translational Studies Program (OTSP)-research… more
- Tris Pharma (Monmouth Junction, NJ)
- …a leading privately-owned US biopharmaceutical company with a focus on development and commercialization of innovative medicines addressing unmet patient needs. We ... have an immediate opening for a Head, Medical Science Liaisons (MSLs) / Director , Medical Training for our Pain division. This is a field-based position that… more
- Merck & Co. (North Wales, PA)
- …access and identifies value evidence needs to provide strategic input into clinical and market development programs.-Develops the integrated evidence strategy ... Job Description Director , Outcomes Research Vaccines Position Description Under the...health systems, and clinicians. -This role will focus on development of research that is relevant to vaccination policy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of technical training across all CMR functions, and compliance across clinical development , medical, and regulatory roles/processes/SOPs Develop and implement ... development , effective execution of CMR role-specific/technical training (eg clinical trial-related, patient safety, therapeutic area leads, MSLs etc.) across… more
- Merck & Co. (North Wales, PA)
- …and maintaining programs in harmony with the portfolio . In addition, the Associate Director will be expected to participate in development of tools and ... plans. - Under the guidance of the CIPM Director & Portfolio Lead , the core responsibility of...MBA, Ph.D. , PharmD) preferred Experience and knowledge of clinical drug development strongly preferred; including the… more
- Merck & Co. (Rahway, NJ)
- …and Pharmacometrics (QP2) department drive model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/ development ... at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate Director … more
- Merck & Co. (Rahway, NJ)
- …capabilities through the following responsibilities.Responsible for achieving results on major program deliverables by identifying, driving the development and ... Job DescriptionR5 - Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsThe Quantitative Pharmacology and Pharmacometrics (QP2) department… more
- Merck & Co. (Rahway, NJ)
- …control and risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ... cross-functional Device Working Groups to ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and… more
- Merck & Co. (Lower Gwynedd, PA)
- …The Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late Development ... IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data.… more
- Insmed Incorporated (New York, NY)
- …healthcare influencers.Full support and execution of Medical Affairs plans, Clinical Development projects, programs, and initiatives.Job Requirements:An advanced ... synthesize and deliver HCP derived scientific insights to Insmed.Support research and development programs as requested by R&D, Clinical Operations, and Medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …research vendors, & budget management. RelationshipsThe fellow will report to the Senior Director RWE during the program and will work closely with all ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the Medical, Clinical Development , Clinical Scientists, Clinical Safety and Pharmacovigilance and Biostatistics program teams to meet needs of ... for delivery of medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to… more
