- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple ... safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of… 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- … Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, ... scientific integrity and interpretation of study data of a clinical development program. The Associate Director...and GCP guidelines as well as applicable SOPs regarding clinical safety + Possesses proficient scientific expertise… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- … Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, ... scientific integrity and interpretation of study data of a clinical development program. The Associate Director...and GCP guidelines as well as applicable SOPs regarding clinical safety + Possesses proficient scientific expertise… more
- Mercy University (Dobbs Ferry, NY)
- Nursing Associate Director of Clinical Simulation Lab Print (https://www.schooljobs.com/careers/mercyedu/jobs/newprint/4377897) Apply Nursing Associate ... Non-Union + Description + Benefits Job Posting Summary The Associate Director of the Clinical ...medical skills learning lab. Recent medical surgical experience. + Safety standards and practices used in lab/classroom settings. Education… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …therapeutic area preferred, along with relevant industry experience. A minium of 2-3yr ( Associate Director ), 4-8yr ( Director ) prior industry experience or ... The Associate Medical Director works with their...ICH and GCP guidelines as well as SOPs regarding safety * Authors clinical sections of communications/documentation… more
- Merck (Rahway, NJ)
- …and therapeutic expertise for the design, planning and execution of early phase clinical trials with the Clinical Director and internal/external team ... objectives and resolves project performance issues if they arise. Ensures appropriate clinical safety assessment and risk management of compounds. Conducts… more
- Pfizer (Pearl River, NY)
- …into country feasibility. **Support study team** + With supervision of medical monitor ( director /Sr director ) provides clinical input to protocol/study team ... Contributes to medical review and interpretation of efficacy and safety data from clinical trials; this includes...+ Provides protocol specific training to study team, investigators, clinical research associate , and others. + Interacts… 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, ... an assigned therapeutic candidate: Responsible for the analysis of clinical data, including safety monitoring, responsible for...academic clinical trials (10 years post fellowship clinical and research experience, associate or full… 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...+ Provides protocol specific training to study team, investigators, clinical research associate , and others. + Interacts… 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...+ Provides protocol specific training to study team, investigators, clinical research associate , and others. + Interacts… more
- Bristol Myers Squibb (New York, NY)
- …data generation, insight generation and patients' access to medicine. The Regional Associate Director (RAD) role is field-based and focused on managing ... support of BMS medicines and all phases of associated clinical trials. The RAD oversees their regional team to...timelines + Contributes to managing external communication when significant safety issues arise, with the well-being of patients being… more
- The Mount Sinai Health System (New York, NY)
- … safety aspects of clinical research trial(s). Under guidance of the Associate Director of Research and Quality Outcomes, the CRA is responsible for ... The Clinical Research Associate is an integral...The Clinical Research Associate is an integral part of the research...collecting, assessing and processing Adverse Events (SAE) for safety reporting, CEC and DSMB of clinical … more
- Bristol Myers Squibb (Berkeley Heights, NJ)
- …every treatment we pioneer. Join us and make a difference. **Purpose** The Associate Director , Biostatistics is a core member of cross-functional development ... the development and execution of statistical aspects for one or more clinical trials, including contribution to study trial design, analysis planning, study results… more
- Merck (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... position is also responsible for implementing actions to meet Safety and Environment (S&E) and GMP requirements as well...pilot plant. The Facility Lead position reports to the Director of Operations/Head of SSO Pilot Plant and the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …develop programming submission strategy, perform integrated analysis of efficacy and safety , generate submission data package, create TLFs to support submission QAs, ... perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory...effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis - Develop and maintain necessary… more
- Pfizer (New York, NY)
- …Proficiency with global regulatory guidance (especially ICH, FDA, and EMA) relevant to clinical and safety data + Comprehensive understanding of the drug ... + The Medical Writer (Senior Manager) creates documents pertaining to clinical studies and regulatory interactions, including (but not limited to) protocols,… more
- AbbVie (Madison, NJ)
- …interactions (Payers, Patients, Prescribers, and Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); ... (medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities).… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, ... Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management. Develop a strong, positive strategic business partnership with the global R&D business and… more
- Pfizer (Pearl River, NY)
- …vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting ... set of disciplines in DSRD, on the design, analysis, and interpretation of nonclinical safety studies. You will be part of a team of nonclinical statisticians within… more