- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. As a senior member of Clinical Operations , the Senior Director , Clinical Operations ... milestones for the company, drawing on expertise in clinical and regulatory requirements, both local and...leading to submission for world-wide marketing applications. The Senior Director , Clinical Operations will be… more
- Bausch Health (Bridgewater, NJ)
- …timely communication of any variances to budget forecast to the Sr. Director or Director of Clinical Operations . + Provide Clinical Operations ... ensure study objectives are being met and provide the operations director and/or senior management with timely...completed in an accurate and timely manner. + Provide Clinical Operations support to the Regulatory… more
- New York Genome Center (New York, NY)
- The Administrative Director , Clinical Laboratory Operations reports to the Chief Diagnostics Officer and is responsible for overseeing all of the ... operations of the clinical lab, supporting the Manager, Clinical Operations through strategic input, leadership, and oversight. + Ensures appropriate… more
- Merck (Rahway, NJ)
- …GCTO Country Operations , other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is fully ... clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head...regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies… more
- J&J Family of Companies (New Brunswick, NJ)
- Director Clinical Operations DPS - 2406189771W **Description** Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation ... more information, visit www.depuysynthes.com. We are currently seeking a ** Director - Clinical Operations ** to... studies, for the supported franchises delivering high quality clinical data to support Regulatory , Market Access,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …the care of patients with life-threatening diseases. We are seeking a strong, experienced Director for Clinical Operations in our Oncology - Early Phase ... as well as driving department goals and initiatives to desired outcomes + Clinical operations oversight of oncology early phase programs, including tracking and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary** The Executive Director , Global Clinical Operations Study Management Group Head ... study management and delivery for all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the clinical … more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …and Development ( Clinical Development & Medical Affairs, Strategic Operations , Evidence Generation & Data Sciences, Regulatory Affairs, Pharmacovigilance) ... Job Title Senior Director , Clinical Development & Medical Affairs...development programs, ensuring they meet the highest scientific and regulatory standards. The Senior Director will also… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … regulatory strategy, post-marketing commitments,post-marketing development and maintenance, regulatory operations and filings-related activities including ... on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs, is responsible for the development and… more
- Merck (Rahway, NJ)
- …solutions to the world. **Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:** + Developing regulatory ... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and...but are not limited to:** + Reports to Executive Director or Associate Vice President, Therapeutic Area Lead. +… more
- NYU Rory Meyers College of Nursing (New York, NY)
- …Identity Share this job (https://uscareers-nyu.icims.com/jobs/12895/ director %2c- clinical -research- operations ... NYU Oral Cancer Center. Primary responsibilities of this position include: (1) supervise all clinical and clinical research operations housed in the NYU… more
- J&J Family of Companies (Raritan, NJ)
- …leadership teams on development plans or program-related issues * Working with Global Clinical Operations (GCO), Regulatory , and Global Medical Safety, leads ... affairs, data management, medical writing, biostatistics, global medical affairs, clinical pharmacology, clinical operations , health economics, epidemiology… more
- Merck (Rahway, NJ)
- …monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior Clinical Director May Be Responsible For:** + Evaluating pre- clinical ... **Job Description** The **Senior Clinical Director (Sr. Principal Scientist)** has...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical… more
- Sanofi Group (Bridgewater, NJ)
- …and clinical study reports + Assisted by related functions (eg clinical operations , project management, and procurement), responsible for timelines, budgets ... **Principle Clinical Research Director - Gastronenterology** The...applicable standard operating procedures (SOPs) + Medical support to clinical operations team during clinical … 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 MAA for the company, drawing on expertise in clinical and regulatory strategy and requirements, both...and requirements, both local and international, related to the clinical medicine and drug development processes. The Director… more
- Intra-Cellular Therapies, Inc (New York, NY)
- …demand integrity and respect in all we do, create and deliver. The Associate Director / Director Clinical Development, will be responsible for the leadership, ... protocol deviation review, and data cleaning in collaboration with Clinical Operations and Data Management 5. Work...status, disability or any other legally protected status. Associate Director Clinical Development Base Salary range $175K… 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 ... progression of portfolio **Health Authority Interactions** + Serves as primary clinical representative in regulatory interactions for early development projects… more
- Intra-Cellular Therapies, Inc (New York, NY)
- …a highly motivated, detail-oriented and results-driven individual to join our company, in the Clinical Operations Department as a Director of Clinical ... clinical trial process. As a leader for clinical programs, the Director , CTM is accountable...is required; Master's degree preferred + 10+ years in Clinical Operations is required + CNS experience… more
- Sanofi Group (Bridgewater, NJ)
- …profile during development and LCM, in strong collaboration with pharmacovigilance and clinical operations teams + Implements strategies to identify, monitor and ... The Clinical Research Director (CRD) is the...documents such as: meeting requests and briefing packages for Regulatory agencies, extended synopsis/protocol for clinical trials,… more
- Sanofi Group (Bridgewater, NJ)
- …collaboration with the global project team and internal partners such as clinical operations , translational medicine, regulatory affairs, biostatistics, drug ... The Clinical Research Director (CRD), Immunology &...by governance and its execution in close collaboration with clinical operations . The CRD is expected to… more