- 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
- Merck (Rahway, NJ)
- …Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is fully informed and prepared ... **Job Description** Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential… more
- Bristol Myers Squibb (Summit, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Clinical Scientist reports through the Clinical Science function which ... provides scientific expertise necessary to design and deliver clinical studies and programs. **Position Summary / Objective** + Responsible for implementation,… more
- Merck (Rahway, NJ)
- **Job Description** The **Senior Clinical Director (Sr. Principal Scientist)** has primary responsibility for the strategic planning and directing clinical ... 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
- Intra-Cellular Therapies, Inc (New York, NY)
- …national origin, protected veteran status, disability or any other legally protected status. Associate Director Clinical Development Base Salary range $175K ... respect in all we do, create and deliver. The Associate Director / Director Clinical ...as primary contact for medical communication to ensure medical safety within studies. Develop and maintain relationships with sites… more
- Merck (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 and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director will be responsible for managing pharmacoepidemiologic projects and activities with limited direction in support of marketed and/ or ... and others + Working closely with Global Patient Safety Leads, Safety Scientists, Regulatory Affairs, Clinical Scientists and other interested parties,… more
- The Mount Sinai Health System (New York, NY)
- … safety aspects of clinical research trial(s). Under guidance of the Associate Director of Research and Quality Outcomes, the CRA is responsible for ... The Clinical Research Associate is an integral...The Clinical Research Associate is an integral part of the research...collecting, assessing and processing Adverse Events (SAE) for safety reporting, CEC and DSMB of clinical … more
- Bristol Myers Squibb (Berkeley Heights, NJ)
- …every treatment we pioneer. Join us and make a difference. **Purpose** The Associate Director , Biostatistics is a core member of cross-functional development ... the development and execution of statistical aspects for one or more clinical trials, including contribution to study trial design, analysis planning, study results… more
- Merck (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
- 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...effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis - Develop and maintain necessary… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, ... Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management. Develop a strong, positive strategic business partnership with the global R&D business and… 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
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …Affairs. Direct reports include Director of Field Medical Excellence, Associate Director Global Medical Information and direct reports, Senior Manager ... Job Title Senior Director , Medical Information and Field Excellence Requisition JR000014200...medical directors/leads, field medical teams, commercial, regulatory, legal, and clinical development as well as external partners and serves… more
- BluePearl (New York, NY)
- …a collaborative, engaged, and passionate veterinary leader with several years of clinical experience to lead our team of emergency and specialty clinicians in ... the role of **Medical Director ** . The Medical Director will partner...(patient care, client and referral veterinarian satisfaction, and patient safety ), **supporting quality and operational initiatives, fostering a clinician-driven… more
- Merck (Rahway, NJ)
- …and 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… more