- 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 (Summit, 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 (Summit, 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
- Pfizer (New York, NY)
- …of the key International IDM cluster regulations in product approval, promotional conduct, safety reporting, and clinical research and good understanding of the ... interactions. We also generate actionable insights on our medicines and the evolving clinical reality and collaborate with our colleagues to ensure that they are… 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... trials (design, operational plans, settings) based on these clinical development strategies + Monitoring and managing … 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Clinical Science (I&I) will lead the early- to late-stage development ... and requirements, both local and international, related to the clinical medicine and drug development processes. The Director...senior management on a global basis. + Supports regulatory safety reporting for clinical programs as needed:… 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)
- The Global Patient Safety (GPS) Lead role ( Director of GPS) serves as the first point of contact (POC) for all safety related issues for the compound(s) ... 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
- J&J Family of Companies (New Brunswick, NJ)
- Sr. Director , Senior Safety Officer- Johnson &...development + Proven track record in dealing with difficult safety issues, clinical safety data, ... that safety standards are maintained along the entire program & clinical development continuum (as appropriate). + Guiding safety evaluations across the… 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …and/or relevant medical field or equivalent in lieu of a PharmD / PhD / MD degree of industry experience in drug safety including significant experience with ... Therapeutic Area (TA) Head of General Medicines, the Senior Director is a key role that contributes to the...PSURs/ DSURs/(d) RMPS; or in clinical development with demonstrated achievements in safety … more
- Danaher Corporation (New York, NY)
- …lives with diagnostic tools that address the world's biggest health challenges. The Senior Director of Medical Safety and Compliance will lead the Medical ... role is crucial in maintaining high standards of medical safety , compliance, and regulatory adherence at Beckman Coulter Diagnostics....The essential requirements of the job include: + Physician ( MD or equivalent) + 6+ years of clinical… 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …Reporting into the Senior Director of the Medical Science Early-Stage, the Director , MSES will lead clinical and scientific aspects of Early Development ... (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions.… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …as required for senior management on a global basis. + Support regulatory safety reporting for clinical programs: SAE assessment, queries and follow-up, annual ... As a senior member of Medical Science, the Senior Director , Medical Science - Early Stage will lead the...MD /PhD is required + Minimum of 12-15 years clinical development experience, preferably some experience in large pharmaceutical… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of ... accessible for MSK employees. Job Description We're hiring an experienced Medical Director to lead ourEmployee Health (EH)department! This role is crucial in… more