- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy, design, ... guidance for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical… more
- Merck & Co. (Rahway, NJ)
- …particular focus on obesity and obesity-related metabolic disorders. - The Senior Director will manage the entire cycle of clinical development , ... reporting, and publication. - Specifically, the Senior Director may be responsible for Evaluating pre- clinical ...areas of responsibility. - To accomplish these goals, the Senior Director may Author detailed development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …changing lives for a living. Are you ready to make a difference? The Position Senior , Clinical Informatics leads the functions in the Clinical Data Science ... & Evidence (CDSE) department of NNI focused on clinical informatics tools development to support the...leadership team and oversees NNI due diligence and other senior level oversight associated with the role Internal/external relationships:… more
- Merck & Co. (Rahway, NJ)
- …to manage clinical development projects; and Assist the Senior /Executive Director /AVP in ensuring that appropriate corporate personnel are informed of ... medicines. Our Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle… more
- Merck & Co. (Rahway, NJ)
- …model informed drug discovery and development for programs .- The Senior Director in Pharmacometrics should provide strategic leadership for pharmacometrics ... leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department will serve to ... of technical training across all CMR functions, and compliance across clinical development , medical, and regulatory roles/processes/SOPs Develop and implement… 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. (Rahway, NJ)
- …Our company's oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire ... commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in… more
- Merck & Co. (Rahway, NJ)
- …Clinical Supply Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the ... development process & connectivity between functions supporting pipeline (ie clinical development , Compound Management Coordination , supply chain, & human… 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)
- Job DescriptionThe Chemical Engineering Research & Development department (CERD), part of the Process Research and Development organization, is seeking a highly ... Ingredient (API) processes meet target yield, purity, and physical attributes for clinical programs across the diverse pipeline. As a recognized expert in the… more
- Genmab (Plainsboro, NJ)
- …regulations and guidance as they relate to global labelingUnderstanding of clinical development of novel biologics products, preferably in oncologyExperience ... to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading the development and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …teams on all aspects of technical transfer including analytical transfer, development studies, clinical supplies, manufacturing scale up, equipment and ... Position SummaryThe Sr. Director of Technical Transfer is responsible for activities...functional teams.Plan, direct and monitor tasks related to process development , scale-up, process optimization, customer technology transfer activities with… more
- Merck & Co. (Rahway, NJ)
- …and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and ... research opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical ... and a can-do attitude to achieve results.You will be reporting to Director , Global Clinical Drug Supply in Copenhagen, Denmark.Main Responsibilities… more
- Merck & Co. (Rahway, NJ)
- …degree (eg, MS, MBA, Ph.D., PharmD) preferred - Experience and knowledge of clinical drug development strongly preferred; including the different phases of ... Job Description Job Description: - The drug development Project Manager is part of Global Project...our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to support optimization of access & reimbursement, clinical practice, product development and registration. The Director serves as a visible PED champion ... organization. Relationships The Director -Patient Centered Outcomes Research reports directly to a Senior Director within the CDSE RWE team. This is a US… more
- Merck & Co. (Rahway, NJ)
- …may:-Manage Directors and/or Senior Directors responsible for Oncology Global Clinical Development projects.-Supervise the activities of entire Clinical ... and ethical standards.-The Distinguished Scientist (Executive Director ) and Product Development Team (PDT) lead, Oncology Global Clinical Development ,… 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
- Genmab (Plainsboro, NJ)
- … Director of US Medical Affairs Solid Tumors Strategy will report to the Senior Director , US Medical Affairs Solid Tumors Strategy Lead. S/he will provide ... healthcare market through collaboration with US Commercialization, Global Medical Affairs, Clinical Development , Regulatory, and other cross functional teams.We… more
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