- Sanofi Group (Washington, DC)
- **Job Title** : Global Clinical Development Strategy Expert-Vaccines **Location:** Swiftwater, PA / Washington DC **About the Job** Within Sanofi ... within the guidelines given by the Global Clinical Franchise Head, the Global Clinical Development Strategy Expert (GCDSE) is a key member of the… more
- Sumitomo Pharma (Washington, DC)
- …safety, and compliance with GCP standards. + Develop and execute corporate clinical strategy for global development projects in Oncology + Monitor ... future product portfolio + Develop and execute the overall clinical development strategy for Oncology,...data and present findings clearly. + Significant experience with global clinical trials and regulatory process. +… more
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- … strategy . + Working with experts and consultants in the field to refine a clinical development strategy . + Designing clinical trials for the purpose ... clinical development programs, including: + Co-authoring global clinical development plans with...clinical development team to operationalize the clinical develop strategy ,i.e., clinical trials… more
- Amgen (Washington, DC)
- …continuous improvement initiatives in Clinical Program Operations (CPO) and Global Development Operations (GDO). Responsibilities + Line Management of ... level eg, on smaller programs): + Overall delivery of Global clinical program operational strategy ,...delivery through the feasibility and study design process + Development and oversight of clinical program budgets… more
- Lilly (Washington, DC)
- …who are determined to make life better for people around the world. **Purpose:** Global Regulatory Policy & Strategy strives to enable Lilly to deliver ... outcomes, reduce regulatory risk, and improve efficiency in drug development . The purpose of the Sr. Director - GRA.... The purpose of the Sr. Director - GRA Global Regulatory Policy & Strategy - Oncology… more
- Merck (Washington, DC)
- …and drive alignment with the goals, purpose and mission of our company Research Labs, Global Clinical Development (GCD) and GCTO. + Positive proven success ... development of their country / cluster to deliver clinical trials as per global clinical...when appropriate Human Health. + Working with regional and global colleagues develops and executes the GCTO strategy… more
- IQVIA (Falls Church, VA)
- …and/or business development purposes + Directly line manage a small global team of regulatory specialists + Mentor, coach, and share subject matter expertise ... extended periods of time. + Travel as required. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence… more
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- …stakeholders, and assist in the development and delivery of the overall Global Quality (GQ) strategy . + This position is responsible for ensuring internal ... direction, and leadership to the Global Quality function with responsibilities for Global Clinical Quality (GCQ), CSV and GPV. In this role, the leader… more
- Norstella (Washington, DC)
- … and delivery of the Advisory Services business, with a particular focus on Clinical Development use cases, offerings and capabilities. You will focus on three ... capabilities using our leading data and software solutions within the area of Clinical Development and spanning multiple use cases. These responsibilities will… more
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- …Collaboration: Collaborate closely with other key functions, including regional medical leads, clinical development , global value and real-world evidence, US ... **Company Overview:** Otsuka is a global healthcare company driven by our purpose "to...1) assets either within Medical Affairs, Regulatory Affairs, or Clinical Development is preferred. + Minimum of… more
- Amgen (Washington, DC)
- …evidence plan for the indication(s). + Provide oversight of LCM clinical development with input on global strategy + Support cross-functional and ... external committee meetings as delegated by Global Development Lead. + Identify new clinical research...Experience in development lifecycle management to include development strategy creation for large programs from… more
- Amgen (Washington, DC)
- …input from the GRT members to develop a global regulatory strategy which supports product development , registration and lifecycle maintenance. Identify and ... provides global regulatory leadership, expertise, and execution for the development , registration, and life cycle management of all Amgen molecules. In this… more
- Amgen (Washington, DC)
- … clinical expert to provide clinical /scientific knowledge into the development , delivery and communication of the global scientific/medical evidence plan ... including leading the evidence generation team. + Serve as global development lead for specific small cell...Integral contribution to SCLC product team + Manage a clinical development team of clinical … more
- ThermoFisher Scientific (Frederick, MD)
- … clinical team for an indication: translating the TPP as set by the Asset Strategy Team into a Clinical Development Plan that answers the relevant ... planning for the indication during all the stages of development . Own the Clinical development ...emerge in the indication + Line management of the Global Clinical Trial Physicians working on the… more
- Sumitomo Pharma (Washington, DC)
- …Biostat/Data Management, CMC, Biomarker/Translational Research, preclinical DMPK, etc to formulate clinical pharmacology development strategy and detailed ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...plan to support overall clinical development program. S/he will be responsible for developing … more
- Norstella (Washington, DC)
- …development and is looking to continue a successful career in a global business with strong career development opportunities. Competitive salary plus ... of the global pharmaceutical industry * Wealth of knowledge on clinical trial operations and confidence in dealing with stakeholders responsible for clinical… more
- Gilead Sciences, Inc. (Washington, DC)
- …participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities. + Experience ... experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities. + Line… more
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- …with 2 years' experience in regulatory affairs or related areas (eg, clinical development , project management, quality assurance, etc.) in pharmaceutical or ... **Position Summary** Provides critical support in developing global regulatory strategy , planning and execution of global investigational and marketed… more
- Otsuka America Pharmaceutical Inc. (Rockville, MD)
- …teams, plan and optimize clinical pharmacology strategies and integrate them into clinical development plans to support drug development and regulatory ... development in collaboration with pharmacometrics, biomarker, statistics and clinical development functions (as relevant). + Interact cross-functionally… more
- Gilead Sciences, Inc. (Washington, DC)
- …experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities. + Line ... member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we… more