- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in R&D as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi ... make available to senior leadership at DP0. Surface expert knowledge on safety biomarkers that might be used in preclinical and clinical development by closely… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire...the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , ESQL is responsible for all activities at the External Entity (EE) site associated with the manufacturing of company products ... all applicable regulatory requirements, regulatory filings and company policies.The Associate Director also ensures that effective and robust Quality systems are… more
- Merck & Co. (Rahway, NJ)
- …provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position will report to the Director ... production, utility systems and associated infrastructure.- Responsibilities of the Senior Specialist - Manufacturing Automation include the following:The automation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an ... of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and regulatory ... study; Consults with KOLS for advice on complex development or safety issuesScientific, Program related: Integrated Study Team (IST) representative or IST… more
- Eisai, Inc (Nutley, NJ)
- …planning and supportive tactics for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be responsible for working with ... Essential Functions Medical Affairs Strategic Plans: Under the direction of the Senior Medical Director , work with key stakeholders, management, and functional… more
- Eisai, Inc (Nutley, 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 ... communication/publication components of overall medical operating plan. The Medical Director provides strategic development, planning, implementation and oversight of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relevant stakeholdersPartners with cross-functional leaders incl. from across RD, Safety , Tech/Supply and Commercial to coordinate SMEs and engagement activities ... with trade associations and other industry groups on key topicsIn the short term, act as the US Reg Policy Lead, responsible for tactically coordinating engagement with US regulatory bodies and trade associations, incl. PhRMA. Qualifications: Successful… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …topics, and supports PV Operations' medical review function. This position supports a senior physician in evaluating and mitigating safety signals as they arise. ... centered around rare diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on current… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and regulatory ... Collaborates with CSPV to ensure monitoring / reporting of AEs/SAEs, Reviews safety reports/data during study conduct, Provides and documents oversight of medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) ... charter, etc), clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA responsesInteractions with the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and analytic support ... analysis of epidemiologic studies, including real-word evidence (RWE), supporting senior management in various epidemiological activities.This position independently carries… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to the SR Director Sales Reporting & GtN. Internal relationships include Senior HQ & local leadership, brand VPs, FP&A GtN and forecasting COE's, and Supply ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewThe Director , Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director , Head of Toxicology and ... you will represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies,… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as a strategic partner ... Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical/Clinical Departments. The incumbent will provide… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... trends of Novo Nordisk and competitor products that impact the volume outlook to senior leadership in a clear & consistent fashion. This position plays a critical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical ... Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... to maximize your potential with us? The Position The Senior Manager, Commercial Insights & Analytics, provides insights and...and impact on NNI business. Relationships Reports to a Director of Semaglutide Anaytics in CI&A and will act… more
