- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on current ... clinical practice and guidelines, reviews and provides written assessments...position supports a senior physician in evaluating and mitigating safety signals as they arise. Additionally, this position works… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve ... standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stud(ies).Ensures trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …are an equal opportunity employer including veterans and people with disabilitiesSummaryThe Associate Director , Global Oncology Clinical Development (GOCD) ... generation (checklist, process map, etc.), change management and detailed analysesThe Associate Director , GOCD Functional Excellence must have excellent verbal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft… more
- Insmed Incorporated (Bridgewater, NJ)
- …internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations, non- clinical safety , contract research organizations ... for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …develop programming submission strategy, perform integrated analysis of efficacy and safety , generate submission data package, create TLFs to support submission QAs, ... perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting- Develop DSI programming… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in place ... around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the...(global/ local), and not limited to: Global Project Team, Safety Management Team, Clinical Safety … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle...clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,… more
- Merck & Co. (Rahway, NJ)
- …that provides a high degree of technical and project management responsibility. The Associate Director - Process/Facility Engineering position will report to the ... infrastructure.- Responsibilities include the following:The process/facility engineer role at the Associate Director level will serve as a technical mentor… more
- Merck & Co. (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... position is also responsible for implementing actions to meet Safety and Environment (S&E) and GMP requirements as well...pilot plant. The Facility Lead position reports to the Director of Operations/Head of SSO Pilot Plant and the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIt is critical that, for all company-sponsored clinical trials, patient safety , high quality data and compliance with company requirements and ... achieve those objectives. -Under the guidance of the Regional Director , Clinical Quality Management (RCQM), and in...functional lines. - -This includes line management of Country Clinical Quality Managers (CCQMs) and Associate Country… more
- Merck & Co. (Rahway, NJ)
- …regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary activities include, ... but are not limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead.Develops worldwide product regulatory strategy to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position supports safety monitoring and risk management activities, provides insights on current ... clinical practice and guidelines, reviews and provides written assessments...position supports a senior physician in evaluating and mitigating safety signals as they arise. Additionally, this position works… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …This position will be a member of the Risk Management Center of Excellence office who will help manage risk management initiatives and activities defined by ... leadership. Individual will provide strategic advice, teachings, and support related to risk management planning, risk management sciences, and risk management tools and resources. **Responsibilities** - Strategic Advice and Support to Global Product Teams: 1)… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, ... scientific integrity and interpretation of study data of a clinical development program. The Associate Director...and GCP guidelines as well as applicable SOPs regarding clinical safety + Possesses proficient scientific expertise… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , Clinical Pharmacology and Pharmacometrics (CPP) - 2406190600W **Description** Johnson & Johnson is recruiting for an ** Associate ... health for humanity. Learn more at https://www.jnj.com/ . The Therapeutic Area (TA) Clinical Pharmacology (CP) Associate Director role within Clinical… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director , Clinical Scientist leads in the development, evaluation, planning and execution of hematology oncology clinical studies and ... on clinical studies and programs. May be responsible to manage one or more clinical scientists. As an Associate Director , a typical day may include the… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Clinical Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #367 Wednesday, May 8, 2024 Looking for a chance to make a meaningful ... and manages multiple complex global studies to support the Clinical Development Plan. The Associate Director...procedures and oversees the quality of the data and safety of the patients. Communicates deviations from the protocol,… more
