- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global ... function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in place for quality… 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)
- …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
- 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)
- …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
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewOverview The 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with a specific focus on infrastructure, budget and non project initiatives. The Senior Director , Global Head of CR2 Project Management & Operational Excellence ... a culture of innovation across the whole organization, encouraging psychological safety and agile methodology to boost creative thinking and continuous improvement-… 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 DescriptionDescription:The Senior Principal Scientist reports to the Senior Director Chemical Biotechnologies of Process Research & Development Enabling ... is expected.Nature and Scope of Position: This role reports to the Senior Director of Chemical Biotechnologies within Enabling Technologies, Process Research… more
- Merck & Co. (Rahway, NJ)
- …provides a high degree of technical and project management responsibility. The Senior Specialist - Process/Facility Engineering position will report to the ... Director , Engineering and will be a member of the...production, utility systems and associated infrastructure.- Responsibilities of the Senior Specialist - Process/Facility Engineer include the following:The process… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …this role, the incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the ... make a difference?The Position We are seeking an enthusiastic Senior Medical Doctor with a high degree of scientific...of clinical trials, the drafting of medical/ scientific documents, safety monitoring, and data analyses. In this high visibility… more
- Merck & Co. (Rahway, NJ)
- …DescriptionIt is critical that, for all company-sponsored clinical trials, patient safety , high quality data and compliance with company requirements and regulations ... operations to achieve those objectives. -Under the guidance of the Regional Director , Clinical Quality Management (RCQM), and in collaboration with the Clinical… 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
- Merck & Co. (Rahway, NJ)
- …to achieve our corporate Scope 3 near-term and Net Zero objectives. As the Senior Specialist - Supplier Sustainability - Value Chain Emissions & Engagement , you ... 3 program. In this role, you will report to the Scope 3 Program Director . You will contribute across various workstreams, among which supporting our company with… more
- Tris Pharma (Monmouth Junction, NJ)
- …in our Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development. Title and salary commensurate ... teamsReviews data generated during study execution to formulate medical understanding of safety and efficacy resultsActs as Medical Monitor for one or more studies,… 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
