- Aequor (New York, NY)
- …The Supply Chain Business Lead (SCBL) is responsible to advance and grow the Global Clinical Supply (GCS) business of delivering clinical supplies to ... with business lines across GCS. Use technical operational and Clinical Development portfolio data to analyze and...field. At least four years of professional experience within global clinical supply in a pharmaceutical company… more
- Merck & Co. (Rahway, NJ)
- …drive alignment with the goals,-purpose and mission of our Company Research Labs, Global Clinical Development (GCD) and GCTO.Ability to identify problems, ... Operations.Collaborates internally with HQ functions, regional and local operations, EU Clinical Development , Pharmacovigilance, Regulatory Affairs, Global … more
- Merck & Co. (Rahway, NJ)
- …and drive alignment with the goals, purpose and-mission of our company's Research Labs, Global Clinical Development (GCD) and GCTO.- Ability to identify ... Collaborates internally with HQ functions, regional and local operations, EU Clinical - Development , Pharmacovigilence, Global Medical Affairs to align… more
- Merck & Co. (Rahway, NJ)
- …intellectually curious, join us-and start making your impact today.- - Overview:- - - Global Clinical Trail Operations (GCTO) is a global organization with ... responsible and accountable for the execution of the Merck clinical research portfolio. The Global Clinical...Trial Operations Exposure to Senior level positions within the clinical development Hands-on experience in the conduct… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Guide the Clinical Science staff in the creation of the development strategy ensuring the highest scientific/medical standards in accordance with ethical ... organizations, co- development partners, and strategic outsourcing.- Contribute to Clinical (oncology) Development initiatives, global education and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Inspection Readiness (IR) and pre-approval Inspection preparation activities for global clinical operations, responsible for representing the GCO-CQM inspection ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical Science function. He/she will be ... not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global ...Clinical Science staff in the creation of the development strategy ensuring the highest scientific/medical standards … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This ... consistency and compliance across clinical study safety reporting and activities. Global Clinical Study Start-Up Documentation: Reviews all clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), ... Risk Management Plans (RMPs) (design, management, and maintenance) for global clinical trials.Provide day-to-day support to study...trial execution in one or more key functions (eg clinical research & development , clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …that are inclusive and representative of diverse patient populations- Collaborate with Oncology Clinical Development Global Clinical Leads to ensure ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs...of Clinical Trial (CT) Diversity sits within Global Oncology Clinical Development , an… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… 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 the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with DS standards . The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd Party Vendor Management and Oversight: ... accountability for operational study level time, cost and quality deliverables.Lead the development of the clinical study plan including critical path activities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. SummaryThis new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is dedicated ... by external partners such as CROs. Exceptions must be discussed with clinical development .Review, approve and/or drive related process related improvement to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …outcomes (PROs), ensuring the payer perspective is incorporated in the assigned clinical development programs and the evidence needed to support optimal ... with HEOR sections in target product profiles (TPPs), product development plans, clinical development plans,...Global Value Dossiers- Propose and implement analysis of clinical trial data for cost effectiveness models and market… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Director, Global Clinical Operations (GCO) Clinical Trial Operational Risk & ... alignment on CRO/Vendor oversight standard practices across GCO and work with Global Clinical Operations, as needed, to understand business priorities.Develop… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead. ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the ... in the strategic planning for future change. Subject matter expert on global clinical trial registration, result posting, plain language summary, redaction… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an advanced degree required.6-9 years of experience with a bachelor's degree required. Clinical development or post-marketing experience to be able to apprehend ... (SAPs) and statistical outputs (tables, figures, and listings [TFLs]), and other clinical study documentsAuthors or oversees the development of safety sections… more
