- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective;… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Director , Global Clinical Trial Operations (GCTO) Project Management Office (REMOTE) The core responsibility of this role is ... direct the execution and coordination of major change projects across Global Clinical Trial Operations (GCTO). The role will also contribute to the Program… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , ... into CDP planning and individual protocols to facilitate successful implementation of programs. Clinical OperationsEnsure high quality delivery of all studies for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the ... business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise...senior CSPV/ Medical Affairs leadership teams to ensure Quality is consistently and proactively represented at program level… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator ... (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical... Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director ,… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development. Title and salary commensurate with ... experience. The position is a core member of the Clinical Development management team responsible for developing and implementing, in alignment with corporate… 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 ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) ... investigators is expectedThe CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …project teams. This role will be a senior member of the Regulatory, Quality and Clinical Reporting (RQC) team, and will provide mentorship and coaching to ... clinical development and regulatory requirements of a clinical program. The Director will provide high...Writing team. Relationships The Director Medical Writing ( Director ) reports to a Senior Director… 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …writing, review of key dossier documents for submissions globally. Ensure high quality collaboration with Clinical Biomarker and Companion Diagnostics team for ... submission plans), including HA engagement plans and mitigation strategies.Ensure high quality collaboration global regulatory leads and provides guidance to the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Analytics functions and translating into business impact. Relationships Reports to the Senior Director , Enterprise Functions Insights Lead with direct management ... to maximize your potential with us? The Position The Director , CMR Insights Lead is responsible for leading the...drive organizational action, guide the Business units and the Clinical , Medical, and Regulatory Affairs (CMR) teams on strategy… more
- Merck & Co. (Rahway, NJ)
- …tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with ... and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead cross-functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and qualitative means. Candidate will define Key Performance Indicators, Key Quality Indicators, Key Risk Indicators, and other targeted operational metrics in ... Identity key milestones at Study, Country, and Site Level to gauge clinical trial performance. Build and Maintain Metrics Catalog, Dashboards Catalog along with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indications; Interacts with our Discovery and Research programs for development of early clinical studies. Provides senior level clinical representation at ... senior management of CRO, as needed; Accountable for clinical development plans, protocol profiles and sections of key...Clinical Monitoring review of data for safety (with Clinical Safety Pharmacovigiliance) and quality at project… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Field Medical Excellence (FME) will develop field medical functional ... strategy to enable high- quality , impactful customer engagements with a consistent approach worldwide....customer engagements with a consistent approach worldwide. The FME Director will also drive operational excellence across the regions.… 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)
- Job DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... partnering to build a culture of innovation and inclusion.-The Director reports to the Executive Director , Cell...be directly responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …within the Global Clinical Science function. This position may be at the executive director level or senior director level, depending on the scope and ... from the clinical science perspective, and ensure the writing of high quality clinical trial protocols, review of clinical data and Clinical Study… more
