- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Director , Global Clinical Trial Operations (GCTO) Project Management Office (REMOTE) The core responsibility of this ... across initiatives and adapt plans based on evolving needs to ensure on-time, high- quality delivery in accordance with the stated project goals. Promote… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety, will be a product safety lead or part of ... a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program management, ... of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functions (eg clinical research & development, clinical science, clinical quality assurance, project management) Preferred requiredStrong leadership, ... for risk and issue management with strategic development partners.Close partnership with clinical quality management and other compliance functions within and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as Global Clinical ... TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … clinical operations experience in trial diversity and patient access and/or clinical operations project management preferably with a sponsor company at a ... and immune disorders. SummaryThis new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is dedicated to GCO. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(eg clinical research & development, clinical science, clinical quality assurance, project management) requiredStrong leadership, collaboration, ... in due diligence activities during the vendor selection process.Close partnership with clinical quality management, SVO and other compliance functions within and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred. Clinical Project Management experience required. Time spent directly in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development, ... improvement opportunities.Communicate and reinforce content and interpretation of Daiichi Sankyo's Clinical Data Standards to DS Project and Study teams,… more
- Insmed Incorporated (San Diego, CA)
- …Millennials™ lists.OverviewThe primary responsibilities are to manage all aspects of clinical operations including study planning, financial oversight, project ... of clinical studies milestones to support company budgets, and quality standards.Ensure the clinical department follows appropriate guidelines as it… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with Novo Nordisk policies and procedures. Relationships This position reports to a Senior Director within the Clinical Data Science & Evidence (CDSE) - RWE ... 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
- Catalent (Harman, WV)
- Associate Director , Continuous ImprovementSummary:The Associate Director , Continuous Improvement will work collaboratively with the Sr Director of CI and the ... rapid adoption of best practices.Reporting to the CI Sr Director , this person is a dedicated resource responsible for...growing needs of clients and patients with the highest quality drugs in a timely manner. Catalent is a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …external investigators is expected. The CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and ... Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical...Clinical Study Reports (CSRs)/outputs throughout the project life cycle is optimized across multiple programs. The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator ... find better and more innovative ways to improve their quality of life. We're changing lives for a living.... Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and participate in regulatory agency meetings, if applicable; Defines study strategy across clinical trials within an indication or project ; Attends EOP2 meeting ... 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)
- …minimal-to-no supervision. The Director will work closely with cross-functional project teams, including Clinical Development, Clinical Operations, ... clinical development and regulatory requirements of a clinical program. The Director will provide high...role will be a senior member of the Regulatory, Quality and Clinical Reporting (RQC) team, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …franchise products, in alignment with key global and regional functions. The Global Director of HEOR & RWE Oncology will lead the HEOR and RWE implementation ... key and visible expert leader, he/she will engage the clinical , Medical Affairs and commercial organization and drive the...an effective use of HEOR and RWE methods. The Director will provide HEOR and RWE strategic direction to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head ... CSPV and key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(eg clinical research & development, clinical science, clinical quality assurance, project management) preferredStrong leadership, collaboration, ... research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and Life… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …working in a global matrix of biomarker and translational scientists and clinical operations. The candidate must have effective project management skills ... and clinical development staff in the timely deployment of high- quality biomarkers analysis on clinical samples. Responsibilities 1. Independent contributor… more
