- 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
- 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)
- …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
- 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
- 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
- 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
- J&J Family of Companies (Raritan, NJ)
- Director , Medical Safety Officer, Oncology -...Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for NDA/BLA/MAA filings + ... 2406185159W **Description** Johnson & Johnson, is recruiting for a Director , Medical Safety Officer, Oncology to be...Strategy (REMS), as well as other activities related to managing the safety profile of assigned products… more
- J&J Family of Companies (Raritan, NJ)
- Director , Safety Surveillance Physician (Oncology) - 2406190337W **Description** Johnson & Johnson, is recruiting for a ** Director , Safety Surveillance ... this includes single case signal detection activities for selected products. The Director , Safety Surveillance Physician (SSP) has primary responsibility for… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …to the Global Patient Safety (GPS) Therapeutic Area (TA) Head, the Senior Director , serves as the first point of contact (POC) for all safety related ... review of clinical documents (Investigator Brochures, protocols, clinical study reports, etc.) + Leads cross-functional Safety...equivalent in lieu of a PharmD / PhD / MD degree of industry experience in drug safety… 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 ... scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance...medical monitor for Phase 3 study. + **Medical Surveillance ( MD only):** For large Phase 2 or Phase 3… more
