- Daiichi Sankyo, Inc. (Bernards, 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
- 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...clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,… more
- Merck & Co. (Rahway, NJ)
- …Solid Dosage (OSD) and Sterile operations, the RY119 Development Center, and Global Clinical Supply (GCS) Packaging within the scope of Our Company's Research Labs ... facility (inclusive of RY119) supports the formulation and filling of clinical , stability, and developmental Sterile, OSD and Inhalation supplies. These facilities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of ... Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence to Good Clinical Practices (GCPs), relevant Standard… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft… more
- Merck & Co. (Rahway, NJ)
- …team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific rigor of ... pipeline.This person will:Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and… more
- System One (Basking Ridge, NJ)
- Associate Director , Clinical Safety MD Pharma In New Jersey - Remote (no west coast, only EST or CST) 12 month contract | Up to $100/hr dependent on ... a plus + international MD is okay + 1-3 years of Pharmacovigilance (PV)/ clinical safety experience in pharmaceutical drugs either from relevant work experience… 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)
- …Associate Director to join our Clinical Development team. The Associate Director Clinical Sciences leads in the development, evaluation, planning ... 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 + Promotes consistent first line… 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
- Bristol Myers Squibb (Berkeley Heights, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , Clinical Data Standards is a leadership role ... This role reports to Director or Executive Director , Head Standards Management & Steward within Clinical & Safety Data Insights and Analytics. **Position… more
- 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 ... **Job Description** The Clinical Research Associate is an integral...as assigned. ** Safety Reporting:** + Assists the Associate Director of Research and Quality Outcomes… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate Director , Safety Scientist in... (GPS) will play a key scientific role in safety strategies for molecules in clinical development and ... post-marketing phases, under the guidance of the safety lead. This will include review, analysis and interpretation of safety data (including aggregate data) to… 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...clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,… 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
- Graham Windham (Bronx, NY)
- …day-to-day operations of the Enhanced Family Foster Care Services. With the Clinical Director 's strong administrative and operational oversight, we will ... Clinical Foster Care Director Job Details...family as quickly as possible. Position Responsibilities: Ensures the safety and stability of all children receiving EFFC services… more
- AbbVie (Florham Park, NJ)
- …pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for ... and other program documents. *May oversee the work of Associate Medical and/or Scientific Directors, and of Clinical... Associate Medical and/or Scientific Directors, and of Clinical Scientists working on the same or related programs.… more
- Bristol Myers Squibb (Madison, NJ)
- …by leveraging internal and external best practices and exploring technologies. The Associate Director (AD), Informed Consent Management role reports to the ... for managing the end-to-end process for IC for BMS-sponsored clinical trials. This includes a centralized triage function for... Director of Informed Consent Management. The AD will be… more
