- Insmed Incorporated (Bridgewater, NJ)
- …Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role ... in working with the team to execute the global clinical development plans of brensocatib for the HSindication. Tasks include preparing clinical documents (eg… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …activities in the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development . Internal relationships include ... and project strategic documents, including NNI Evidence Generation Plans and Product Development Plans Clinical study management: Provide regional medical &… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Excellence and Delivery (OED). Key regional stakeholders include: Finance, North America Clinical Development (NACD) Clinical Medical & Regulatory (CMR), ... the oversight and management of the resources within NACD. Relationships Reports to Snr Director of Clinical Strategy and Business Operations within Operational… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , ... research areas centered around rare diseases and immune disorders.SummarySenior clinical operational leader accountable for operational planning and execution of… more
- Eisai, Inc (NJ)
- …a good understanding of other IT systems for contract management and clinical development .#LI-TS1Eisai Salary Transparency Language:The base salary range for the ... and oncology, with a strong emphasis on research and development . Our history includes the development of...want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead… more
- Tris Pharma (Monmouth Junction, NJ)
- …overall and specific project management and organizational leadership expertise to the clinical development portfolio. The incumbent is accountable for the ... in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations.The Senior Director ,...with all regulations and/or guidance. Collaborating closely with Vice President/ Clinical Development , manages and supports the … more
- Eisai, Inc (Nutley, NJ)
- …required.#LI-MI1#IND123#LI-RemoteEisai Salary Transparency Language:The base salary range for the Associate Director , Clinical Data Science - CEG is from ... and oncology, with a strong emphasis on research and development . Our history includes the development of...your profile, we want to hear from you. The Clinical Data Science team at Eisai, Inc., is expanding… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration. ... Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …establishing area-relevant standards, (v) encouraging innovation.Build strong relationships with clinical development , clinical sciences, regulatory, ... and empowers colleagues, influence stakeholders inside and outside of GCO to accelerate clinical development timelines and to create value for patients and the… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- OverviewUnder the direction of the Senior Director of Non- Clinical Drug Development and with limited direction, the Business Development Manager will be ... works to expand its efforts as a Contract Research Organization.The Business Development Manager will work to uncover and cultivate business opportunities to… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key ... Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader… more
- Eisai, Inc (NJ)
- …Studies: Direct and design strategies, planning and implementation of Phase IV clinical development programs for assigned products. Provide medical oversight for ... communication/publication components of overall medical operating plan. The Medical Director provides strategic development , planning, implementation and… more
- Eisai, Inc (Nutley, NJ)
- …studies: Direct and design strategies, planning and implementation of Phase IV clinical development programs for assigned products. Provide medical oversight for ... strategic development , planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products in the… more
- Merck & Co. (Rahway, NJ)
- …for oral products.- This research-based team contributes to Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverables, which is the development of robust ... GMP and compliance mindset, and collaboration with various partners and stakeholders in development is expected.The Director will report to the Executive … more
- Eisai, Inc (Nutley, NJ)
- …in helping to shape and drive oncology pipeline advancement by coordinating with Clinical Development and Clinical Operations. Essential Functions Work with ... strategies for that therapeutic area.She/He will strategize and execute Phase IV clinical development programs for assigned products.Design and review IIS… more
- Merck & Co. (North Wales, PA)
- …project management experience at or supporting -pharmaceutical/biotech companies related to the clinical development processAt least 2 years of experience in ... current publication policies and industry trends.Responsibilities:With oversight from the Director Lead, lead development of and maintain...publication managementUnderstanding of the clinical development process andclinical study data for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages ... these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director... and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology ... The primary responsibilities of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other ... well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety, will be a product safety lead or part of… more
