- Merck & Co. (Rahway, NJ)
- …about driving impactful changes. Position Overview: As the Associate Director of Launch Strategy and Operations, you will lead the enterprise preparation of ... and strong leadership capabilities. Key Responsibilities include: Strategic LeadershipLaunch Strategy Development: Lead the creation of holistic, integrated… more
- Merck & Co. (Durham, NC)
- …at the Vaccine Manufacturing facility in Durham NC, the Supply Chain Logistics Strategy Leader will be responsible for the development, management, and growth of our ... and process enhancements throughout the supply chain - Project Management Lead and sponsor all Supply Chain Logistics initiatives surrounding qualification support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with minimal direction from group head and provide statistical scientific leadership for clinical trial safety data. Lead the statistical support for safety ... rare diseases and immune disorders. Summary: Provide leadership and guidance as the lead statistician dedicated to safety on one or more safety monitoring team(s),… more
- Insmed Incorporated (San Diego, CA)
- …leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on ... and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance… more
- Merck & Co. (Rahway, NJ)
- …Responsibilities: Lead and set direction for the device development strategy for multiple drug-device combination product development programs ranging from ... clinical , regulatory, formulation, commercial and other key company functions. Lead the Device Engineering Sub-Teams focused on development of design requirements… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, ... ( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,-… more
- Eisai, Inc (Nutley, NJ)
- …management.Demonstrated track record as Study Director (or equivalent role) with Global Clinical Lead or Clinical Program Director accountability. Proven ... Clinical Development resides within the Oncology at Eisai. This Executive Director will lead franchise programs, and will be the clinical group leader for the… more
- Merck & Co. (North Wales, PA)
- …Head, Global Clinical Development, Pediatrics will focus on driving strategy , development, and life-cycle management activities for pediatric vaccines in the ... Therapeutic Area. The incumbent will be expected to lead multiple programs that are in various stages of...of development therefore requiring someone who has late vaccine clinical development and lifecycle management experience.The AVP will also… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy : Provides the ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Eisai, Inc (Nutley, NJ)
- …start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support, creates, and communicates clinical ... members and line managers when issues develop. Implements and prepares the clinical development strategy as outlined by the clinical teams. May develop… more
- Eisai, Inc (Nutley, NJ)
- …a team of Clinical Operations staff to oversee all aspects of clinical trial development. Lead clinical study inspections from preparation through ... in engaging with and addressing regulatory agencies.Experience in leading clinical operational strategy development, stakeholder management, vendor relationship… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cross-functionally with multiple functions and groups throughout the US organization, Clinical development, Research & Early Development, other affiliates, and the ... by overseeing 5D efforts including Data, Diagnostics, Drug, Device, and Digital strategy and execution for relevant TAs, aligned closely with Rare Disease… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal marketing communications. They will develop and implement a comprehensive strategy for agency management, lead portfolio promotional materials ... cross-functionally with multiple functions and groups throughout the US organization, Clinical development, Research & Early Development, other affiliates, and the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cross-functionally with multiple functions and groups throughout the US organization, Clinical development, Research & Early Development, other affiliates, and the ... than ever before. The Position The Thought Leader Liaison Lead plays a pivotal role leading a team of...Bleeding Disorders. Relationships This role reports to the Commercial Strategy and Marketing Head and is a key contributor… 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
- Merck & Co. (Rahway, NJ)
- …well as regional and country teams to ensure patient access objectives and strategy are linked to clinical development, commercial and value evidence ... the development and implementation of integrated access strategies, excellence in pricing strategy and execution, and shaping of the external access landscape. We… more
- Formation Bio (New York, NY)
- …proof-of-concept models into scalable, production-ready systems Define technical execution strategy for clinical outcome prediction, indication expansion, and ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...Data Science - Platform at Formation Bio, you will lead one of two critical arms of our Data… more
- Merck & Co. (Rahway, NJ)
- …and Biopharmaceutics, the large molecule product development Director will influence the strategy , lead activities, and develop a team whose roles include ... opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction of the Senior Director, USMA Oncology (US Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical ... or indication. The role is primarily responsible for US Medical Affairs Strategy and overseeing execution of medical activities for assigned indication(s) and… more
- Eisai, Inc (Nutley, NJ)
- …KOLs in AD diagnostic area, biomarker experts, diagnostic companies and independent clinical laboratories. Manage the engagement with them. Lead medical advisory ... Neurology Medical Affairs will provide medical leadership for medical affairs strategy planning and supportive tactics on diagnostics for early Alzheimer's disease… more
