- 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 (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 (Princeton, 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
- 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 (Titusville, NJ)
- … Study Reports (CSR) + Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for NDA/BLA/MAA filings + Periodic Benefit Risk Evaluation Report ... Director , Medical Safety Officer, Pulmonary Hypertension...Strategy (REMS), as well as other activities related to managing the safety profile of assigned products… more
- J&J Family of Companies (Titusville, 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
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …integrity and respect in all we do, create and deliver. The **Executive Director ,** **Pharmacovigilance Safety Physician (PVSP)** serves as the medical safety ... measures for assigned products. + Review and contribute to safety sections within Clinical documents such as...assessments and ad-hoc requests, etc. + Closely collaborate with Clinical Development Study Physician or Study Director … 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...and/or relevant medical field with PharmD / PhD / MD degree required. + Clinical experience and/or… 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
- Novo Nordisk (Plainsboro, NJ)
- …and execution of clinical trials, the drafting of medical/ scientific documents, safety monitoring, and data analyses. The Medical Director will also assist ... equivalent is required + 1+ years Pharmaceutical/Biotech industry experience, including time managing clinical trials, or academic clinical research… more
- Taiho Oncology (Princeton, NJ)
- …and/or investigational products assigned to him/her, including review and analysis of safety data from clinical trials and from post-marketing sources, providing ... and external) to discuss and manages all new emerging safety signals from post-marketing and clinical trials...Minimum of 5 years of experience in a Pharmacovigilance/Drug Safety environment with substantial experience in managing … more
- Novo Nordisk (Plainsboro, NJ)
- …publications strongly preferred + 4+ years Pharmaceutical/Biotech industry experience, including time managing clinical trials, or academic clinical research ... new medicines for patients. The Position As Senior Medical Director for the liver disease team, you will be...clinical trials, the drafting of medical/ scientific documents, safety monitoring, and data analyses. In this high visibility… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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
- J&J Family of Companies (Titusville, NJ)
- …project management, quality monitoring & compliance, data management, global medical safety , biostatistics, regulatory affairs, clinical supplies unit, medical ... Director , Project Responsible Physician - Neuropsychiatry - 2406186566W...**Travel** Yes, 10 % of the Time **Job Function** Clinical Development & Research & MD **Req… more
- CVS Health (Trenton, NJ)
- …are comprised of utilization management, quality management, network management and clinical coverage and policies. Primary Job Duties & Responsibilities: Behavioral ... Health Medical Director + Collaborates with health plan Sr Leadership to...including after-hours consultation as needed. + Leads all major clinical , population health management, and quality improvement components of… more
- Bristol Myers Squibb (Princeton, NJ)
- …The Regional Associate Director (RAD) role is field-based and focused on managing a team of Medical Science Liaisons (MSLs). The RAD is responsible for oversight ... Pharmacovigilance SOPs regarding identification and reporting timelines + Contributes to managing external communication when significant safety issues arise,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …in the real-world setting. + Contributes to creation and improvement of Clinical Development processes. **Education:** + MD required; prefer Board certification ... and medical expert with proven credibility and experienced in patient safety and clinical development. + Experience working in a matrix environment and on… more