- 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
- 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
- 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …help create possible, together. **Job Description** + Serves as a senior scientific and clinical expert for safety profile of products in therapeutic areas + ... signals and trends, and supports management of any potential safety issues Essential Duties: + Oversees clinical ...Leads a portion of BLA submission activities. Requirements: + MD / DO / Pharm D degree or equivalent. Completion… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …clinical studies operate with scientific rigor, comply with the highest ethical and safety standards and are compliant with clinical , ICH and GCP guidelines ... Director Precision and Experimental Medicine - Immunology Date:...population stratification strategies to support the rapid demonstration of safety and efficacy (surrogate biomarkers, intermediate clinical … 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
- 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
- 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