- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders. Summary The Director , Clinical Safety , will be a product safety lead ... specific areas of safety surveillance and risk management, and provide safety leadership including but not limited to clinical studies, post-marketing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryThis 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
- Eisai, Inc (Nutley, NJ)
- …the therapeutic area and 3 years in an in-house Medical Affairs role; MD preferredClinical research experience, including conducting clinical trials in the Phase ... If this is your profile, we want to hear from you.The Medical Director , US Medical Affairs provides medical leadership for medical affairs strategy, planning and… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive ... tactics for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be responsible for working with key stakeholders to develop… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... 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 strategiesMonitoring and managing the conduct… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Represents Clinical Development in Project Teams, possibly as Global Clinical Lead.Responsibilities:Medical Monitoring Planning ( MD Only): For large Phase 2 ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …narratives, Provides medical direction to MW for the CSR; Working with Clinical Safety Pharmacovigilance (CSPV), defines product level surveillance plan and ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …journalsAssess clinical trial and/or other data sources to contextualize safety events for assigned product. Research natural history of disease to characterize ... centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and analytic support… 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 (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...**BASIC QUALIFICATIONS** + Obtained a primary medical degree (eg MD , DO, MBBS, MBChB) from a recognized medical school/university,… 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 to join the Hematology Function as clinical leader of a section of a clinical program (eg, an indication, a new formulation, or a ... specific development phase), under leadership of Program Lead Medical Director (Program Lead MD ). As a Senior...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
- 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
