- 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
- J&J Family of Companies (Raritan, NJ)
- Medical Director / Sr. Medical Director , Clinical ...**Travel** Yes, 10 % of the Time **Job Function** Clinical Development & Research & MD **Req ID:** ... & Johnson Family of Companies, is recruiting for a Director /Senior Director , Clinical Rseearch Physician...Investigator meetings as well as Advisory Boards. **Qualifications** An MD is required; Advanced degree (PhD) is a plus.… 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
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- Job Title Senior Director , Medical Information and Field Excellence Requisition JR000014200 Senior Director , Medical Information and Field Excellence (Open) ... - USA501 Additional Locations Bridgewater, NJ Job Description The Senior Director , Medical Information and Field Excellence is responsible for the oversight… 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
- Sanofi Group (Bridgewater, NJ)
- …Science Liaisons, Medical Education, Medical Communications and Publications, Health Outcomes, Safety and Clinical Research (Phase IIIB-IV and Investigator ... review of ISS concepts/protocols according to applicable SOPs. + Partner with US Drug Safety in the management of clinical trial adverse events, post-marketing … more
- Atlantic Health System (Morristown, NJ)
- …largest non-profit healthcare networks in New Jersey, is seeking a System Medical Director of Women's Services to oversee the strategic growth of the service line ... counties in Northern and Central New Jersey. The Medical Director of Women's Services will provide leadership and direction...leadership and direction on new program development by connecting clinical leaders from across the system, as well as… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ Assess clinical trial and/or other data sources to contextualize safety events for assigned product. Research natural history of disease to characterize ... rare diseases and immune disorders. **SUMMARY** + The Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and analytic support… more
- Sanofi Group (Bridgewater, NJ)
- …Science Liaisons, Medical Education, Medical Communications and Publications, Health Outcomes, Safety and Clinical Research (Phase IIIB-IV and Investigator ... according to applicable SOPs. + Partner with US Drug Safety in the management of clinical trial...+ **Education** : Advanced degree in a scientific discipline: MD , PhD, PharmD + **Work** **Experience** : Significant experience… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety + Performing clinical /medical data review, including safety ... of a clinical development program. The Senior Manager reports to the Director , Clinical Sciences and collaborates closely with Medical Director (s) (MDs)… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety + Performs clinical /medical data review, including safety ... through early and/or late phase development. The Sr. Manager reports to the Director , Clinical Sciences and collaborates closely with Medical Director (s)… more