- 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 (Pearl River, NY)
- …of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety . + The clinician medical ... + Conducts medical review and interpretation of efficacy and safety data from clinical trials; this may... research programs and registration activities. + Responsible for managing multiple studies + 4+ years' work experience. **PREFERRED… more
- Pfizer (Pearl River, NY)
- …of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety . In addition to study ... Ensures the medical review and interpretation of efficacy and safety data from clinical trials; this includes...network for new trials. **BASIC QUALIFICATIONS** + Medical degree ( MD /DO or equivalent) + Licensed by a health authority… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Medical Director , Clinical Sciences, Hematology provides clinical leadership and is responsible for all clinical deliverables within the ... clinical program with minimal supervision from Program Lead MD . Clinical deliverables may include individual protocols...HE&OR), and internal decision boards. + Supports Program Lead MD in ensuring overall safety of the… 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 (Tarrytown, NY)
- … 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 (Tarrytown, NY)
- …with FDA, EMEA, ICH and GCP guidelines as well as SOPs regarding safety * Authors clinical sections of communications/documentation for regulatory agencies and ... The Associate Medical Director works with their supervisor and other members...others; provide input on potential disease areas/indications; and craft clinical experiments that corroborate or inform the biology for… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Medical Director , Clinical Development will play a key role in the NASH/MASH clinical development program within the Regeneron Genetic Medicines ... typical day in the life of a Senior Medical Director may include the following: * Leads clinical...Ensures safety of the drug, including the safety aspects of patients in clinical studies… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- Summary The Senior Medical Director , Clinical Sciences, Endocrinology, will play a key role in clinical development programs within the General Medicine ... demonstrates outstanding clinical scientific knowledge applicable to clinical research. The Senior Medical Director General...Ensures safety of the drug, including the safety aspects of patients in clinical studies… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Medical Director , Clinical Sciences works with their supervisor and other members of the cross-functional study team to author protocols and facilitate ... or inform the biology for decision-making purposes and enable clinical development programs. **As a Medical Director ,...ICH and GCP guidelines as well as SOPs regarding safety * Authors clinical sections of communications/documentation… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Medical Director , Clinical Sciences should be a...of clinical study reports, the analysis of clinical data, including safety monitoring, and all ... pharmaceutical industry experience, preferably in Ophthalmology Therapeutics Development. The Director will serve as Medical Lead for clinical...activities and procedures that ensure patient safety **This job may be for you if you… more
- Merck (Rahway, NJ)
- …physician-scientist or PhD scientist to join our group as a **Principal Scientist ( Clinical Director ) in Translational Medicine/Early Clinical Development in ... MA). Translational Medicine at our Research Division is responsible for early clinical development of novel therapeutics, working in close collaboration with our… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety + With oversight from the GM&ES CDU TFA Primary Responsible, ... aspects of an assigned therapeutic candidate: Responsible for the analysis of clinical data, including safety monitoring, responsible for activities and… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- 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 (Tarrytown, NY)
- …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