- 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 ... all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for... trial portfolio and submissions are delivered to time, quality , and cost. The teams reporting into this role… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful implementation of studies. ... Responsible for management of compounds at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator meetings Serve on ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director , and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …protocol timelines; considers relevant input and guidance to other areas within NACD including Operations Director and TA Heads End to End Supply Operations ... collaboration: Responsible for implementation of best practices and standards for clinical operations , including sharing lessons learned. Partner closely with… more
- Catalent (Philadelphia, PA)
- Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality ... Japanese, and Australian agencies and other international and/or local health authorities.The Director of Quality is responsible for providing leadership and … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …MSA discussions of external vendors by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, Precision Medicine, etc.) ... This position may propose strategies for external data collections ensuring all clinical & companion diagnostics data meet quality requirements and protocol… more
- Insmed Incorporated (Bridgewater, NJ)
- …related issues.Collaborate with multiple internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations , non- clinical ... for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large… more
- Merck & Co. (Rahway, NJ)
- …expanding your career.The Chemistry, Manufacturing & Controls (CMC) Pre-approval Pharm Executive Director is accountable for managing a team of CMC professionals and ... high rigor in CMC regulatory strategy as well as delivery of high- quality CMC submissions for products which could span traditional solid-oral small molecules… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … as part of the Quality team based in Raritan, NJ. Role Overview The Director of Quality Operations , CAR-T is responsible for Quality oversight ... programs . This role will also be responsible for trending of quality operations metrics and developing continuous improvement initiatives for the team… more
- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... a periodic basis. Track action items for completionSupport client projects and provide quality oversight of manufacturing operations and the release of drug… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …position works closely with counterparts in the GS Departments, including Safety Operations , IT & Quality and Customer Complaint Center. External relationships ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Rahway, NJ)
- …new milestones in global healthcare. Our company's Pharmaceutical Sciences & Clinical Supplies organization translates molecules to medicines, working from the ... a range of modalities including small molecules and peptides.- Within OFS, the Director will influence the strategy, lead activities, and develop a team whose roles… more
- Merck & Co. (Rahway, NJ)
- …and clinical development leadership. Responsible for leading deep scientific and clinical due diligence, the quality of formal due diligence output, ... Job Description Position Description: Director , Business Development - Enabling Technologies Search and Evaluation Job The Search and Evaluation (S&E) team is a core… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical Quality Management or other RD business process ... and reviewing quality metrics for the Quarterly Quality Report (QQR) and Clinical Quality...new technologies.Lead Lessons learned information flow at the GPT/ Clinical Operations level based on audits, inspections,… more
- Tris Pharma (Monmouth Junction, NJ)
- …management planning. The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality , etc. to ... safety information updates, potential risks mitigation, etc. Collaborates with appropriate clinical , medical, quality and regulatory counterparts and others… more
- Merck & Co. (North Wales, PA)
- …medical knowledge and editorial skills to contribute to medical education and clinical decision support for healthcare professionals, while also providing high ... quality content for patient education. You would be joining...1 billion users each year.A minimum of 5 years clinical experience and demonstrated writing skills are mandatory. Current… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …studies based on indication specific BICR experience; regularly monitor reviewer metrics for quality control in support of clinical trial endpoint data, and ... areas centered around rare diseases and immune disorders. SummaryThe Director of Oncology Imaging Science and Oversight will be...Years More than 5 years of experience in imaging operations in oncology clinical development of both… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Executive Director (ED) will provide leadership to the DSPV Medical Safety Team. ... executing the safety and risk management activities for one or more clinical development or marketed products throughout their lifecycle. This position reports to… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Executive Director of Cardiovascular (Cardio-renal disease & Heart Failure) will be responsible for overseeing and facilitating research in ... at a new state-of-the-art center in South San Francisco, CA. The Executive Director will contribute to the design, prioritization, and execution of the strategic… more
