- 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
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …maintaining valuation models and transactional, diligence and integration processes. The Medical Director , Medical Safety Officer ( Clinical ) plays a pivotal ... role in establishing and maintaining a medical/ clinical safety oversight and collaborative relationship with...Excellent verbal and written communication skills + Medical degree ( MD , DO) preferred, PharmD, PA, APRN, or RN depending… 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 (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
- 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
- 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
- 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
- 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
- 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)
- …into the Senior Director of the Translational Medicine (TM) group, the Director , TM will lead clinical and scientific aspects of translational studies from ... (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions.… more
- J&J Family of Companies (Trenton, NJ)
- … Clinical protocols, Investigator Brochures, Compound Development Plans generation of Clinical Study Report + Managing the outstanding or in-house ... Senior Director , Oncology Translational Research - Multiple Myeloma -...**Organization** Janssen Research & Development, LLC (6084) **Job Function** Clinical Development & Research & Non- MD **Req… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …areas involving complex indications including rare disease/orphan conditions. The Senior Director , Medical Science will be responsible for clinical development ... as required for senior management on a global basis. + Support regulatory safety reporting for clinical programs: SAE assessment, queries and follow-up, annual… more