- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical ... involving investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics ... plan, including data generations (including RWE), post-marketing research, medical education , research grants, medical advisory boards, and scientific communication/publication… more
- Eisai, Inc (NJ)
- …this is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to ... Salary Transparency Language:The base salary range for the Associate Director , Clinical Outsourcing is from :157,200-206,300Under current guidelines,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; ... Represents clinical function at meetings with health authorities; Oversees management...management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental… more
- Insmed Incorporated (Bridgewater, NJ)
- …Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Director , Toxicology is a key member of the nonclinical ... safety team, reporting to the Executive Director , Head of Toxicology and Molecular Mechanisms. In this role, you will represent toxicology at cross-functional… 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...project team members, and to a limited extent with senior management, and outside vendors; works independently for all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Senior Director , Global Oncology Medical Affairs is responsible for ... as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team, and Global Product Team to… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary:The Global Senior Director Medical Affairs (GDMA) Immunology/Pipeline & Biomarkers will be responsible for driving execution of ... and regionsServes as an impactful member of Product Development Team sub-teams ( Clinical , Value Evidence, Commercial, Publications and Label) and Global Human Health… more
- Lundbeck (Chicago, IL)
- …US medical insights for assessment of global Lundbeck BD opportunities and pipeline clinical development. Furthermore, the Sr Med Dir will build the US MA's future ... to accelerate needed infrastructure within US Medical Affairs. We seek a senior , strategic and highly adaptable candidate, with previous experience in working with… more
- Merck & Co. (Rahway, NJ)
- …analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating pre- clinical and translational ... further study of marketed compounds.In executing these duties, the Senior Director may:Supervise the activities of Clinical Scientists in the execution of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Merck & Co. (Rahway, NJ)
- …Involved in research activities for innovative statistical methods and applications in clinical trial development. Education and Minimum Requirement: PhD or ... developing and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical , Regulatory, Statistical Programming, Data Management, and our Company's… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs strategy, planning and ... execute the medical affairs plan, including post-marketing research, medical education , research grants, medical advisory boards, and scientific communication/publication… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology) studies, support Phase 2/3 studies, represent function on study ... of PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological aspects of the drug.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's global ... area known for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D… more
- Merck & Co. (Rahway, NJ)
- …approaches to develop and implement translational PK/PD strategies, characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and ... biologics, and inform dose selection and go/no-go decisions. Senior Directors lead QP2 efforts to strengthen our pharmacometric capabilities on a continuous basis by… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the Senior Director , GMA Oncology ADC (Global Medical Affairs team lead for ... education and other scientific exchange activities in alignment with the Senior Director , such as scientific symposium and medical congresses, within legal… 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 ... implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new...ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Senior Director , Global Oncology Medical Affairs is responsible for ... as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team, and Global Product Team to… more
