- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders. Summary The Director , Clinical Safety , will be a product safety lead ... specific areas of safety surveillance and risk management, and provide safety leadership including but not limited to clinical studies, post-marketing… more
- 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)
- …known for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as ... possible. This led us to create the Translational Patient Safety Senior Director position, which will have...marketing. Serve as a bridge to Nonclinical Development on clinical safety findings, particularly ones likely to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Represents Clinical Development in Project Teams, possibly as Global Clinical Lead.Responsibilities:Medical Monitoring Planning ( MD Only): For large Phase 2 ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization ... dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials. Position Summary / Objective Serves as a primary source of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …narratives, Provides medical direction to MW for the CSR; Working with Clinical Safety Pharmacovigilance (CSPV), defines product level surveillance plan and ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …journalsAssess clinical trial and/or other data sources to contextualize safety events for assigned product. Research natural history of disease to characterize ... centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and analytic support… more
- Tris Pharma (Monmouth Junction, NJ)
- …and team success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety . The Director , Drug Safety is responsible ... update reports, periodic benefit risk evaluation reports, etc.) Oversees reconciliation of safety data in pharmacovigilance and clinical trial databases Ensures… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role in working ... groups.Contribute to the strategic development of early and late stage clinical programs.QualificationsRequires an MD or PharmD degree, board certified/eligible… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. **Summary** The Director , Clinical Safety , will be a product safety lead ... safety surveillance and risk management, and provide safety leadership including but not limited to clinical...and implement strategies and action plans for identifying and managing risks throughout the product life cycle. - Effectively… 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
- Bristol Myers Squibb (Princeton, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Director will be the clinical lead to progress early clinical ... Clinical Scientist for medical questions and education (including safety management guidelines) + Assesses key safety -related...+ Advanced degree(s) in relevant field: MD , MD /PhD (or x-US equivalent) and clinical expertise… more
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Director will be the clinical lead to progress multiple early ... Safety physicians in the ongoing review of safety data + Provides clinical leadership and...**Leadership and Matrix Management** + May be responsible for managing Early Clinical Development Physicians, attracting, developing… more
- J&J Family of Companies (Spring House, PA)
- …is at its core a deep collaboration between Disease Area experts, CPP, Clinical and Non- Clinical Safety , Translational Science (Biomarker), Translational ... Associate Director , Translational Clinical Medical Lead Translational...listings etc.) + Supports the assessment and review of clinical safety data from studies by collecting… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, planning and execution ... scientific integrity and interpretation of study data of a clinical development program. The Associate Director leads...and GCP guidelines as well as applicable SOPs regarding clinical safety + Possesses proficient scientific expertise… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- Job Title Senior Director , Clinical Development & Medical Affairs (CDMA) Requisition JR000014103 Senior Director , Clinical Development & Medical Affairs ... Headquarters - USA501 Additional Locations Bridgewater, NJ Job Description The Senior Director , Clinical Development Medical Affairs (CDMA) drives strategy and… more
- J&J Family of Companies (Raritan, NJ)
- …to relevant health authorities and consultant/advisory meetings. **Qualifications** Qualifications for the Director Clinical Leader include: + MD (or ... Director , Late Development Clinical Lead -...development plans or program-related issues * Working with Global Clinical Operations (GCO), Regulatory, and Global Medical Safety… 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 ensures ... development projects through early and/or late phase development. Reports to the Director , Clinical Sciences Hematology, Clinical Sciences and collaborates… more
- Intra-Cellular Therapies, Inc (New York, NY)
- …demand integrity and respect in all we do, create and deliver. The Associate Director / Director Clinical Development, will be responsible for the leadership, ... origin, protected veteran status, disability or any other legally protected status. Associate Director Clinical Development Base Salary range $175K - $190K … more
- Sanofi Group (Bridgewater, NJ)
- **Principle Clinical Research Director - Gastronenterology** The Principle Clinical Research Director (CRD) is noted as the primary clinical lead for ... clinical feasibility + Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety , stat outputs of blinded data, etc.)… more
