- Sanofi Group (Waltham, MA)
- **Job Title:** Global Clinical Development Strategy Expert - Vaccines **Location:** Swiftwater, PA or Waltham, MA **About the Job** This role in the ... and/or programs in the development of a pentavalent meningococcal vaccine. The Global Clinical Development Strategy Expert (GCDSE) is the clinical… more
- Sanofi Group (Cambridge, MA)
- …maintain credibility with internal and external stakeholders **Key responsibilities:** + Designs the global clinical development strategy and generates ... studies from early phases to LCM programs + Establish clinical development strategy and lead...key opinion leaders or advisory boards + Serves as clinical team leader/representative at the global project… more
- Sumitomo Pharma (Boston, MA)
- …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. (Boston, MA)
- … 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
- Bristol Myers Squibb (Cambridge, MA)
- …Neuroscience** **Position Summary:** The selected candidate will have leadership responsibility for global regulatory strategy within a development team ... of strategic and tactical role and deliverables of Global Regulatory Strategy in the Product Development and Commercialization process. + Understanding of… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the ... development and implementation of labeling content and strategy of multiple products in various stages of drug development , assigned to self or direct… more
- Sanofi Group (Cambridge, MA)
- …for critical decision-making. The Medical Director will collaborate with internal experts from Global and Local Medical, Clinical Development , and Regulatory ... Global Medical Director, Evidence Generation - Insights and Strategy **Location:** Cambridge, MA, Morristown, NJ **About the Job**... strategy . + Collaborate with R&D teams (eg, clinical development ) to provide analyses to support… more
- Takeda Pharmaceuticals (Boston, MA)
- …for patients with immunologic, hematologic, and other complex diseases. The Global Regulatory Device Labeling Strategy Lead (Senior Manager) Plasma-Derived ... expertise, strategic insight, and guidance to internal stakeholders, including Clinical , Device Development , Pharmacovigilance, Legal, Scientific, Commercial, to… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **OBJECTIVES:** The Global Category Manager (GCM) - Clinical Development Services Procurement at the Associate Director level, plans ... **ACCOUNTABILITIES:** + You will report to the R&D Procurement Clinical Development Services Procurement Lead and, collaborate..."CORFs" and Change Orders "COs". + You will support Global Procurement Leadership in the development of… more
- Sanofi Group (Cambridge, MA)
- …in artificial intelligence (AI) and Generative AI offers enormous opportunities to transform clinical development . To harness the power of new technologies and ... Clinical Data & AI Processing (CDAIP) department within Clinical Sciences and Operations. The Global Head... for leveraging AI and advanced data processing in clinical development ; enable real-time, interactive access to… more
- AbbVie (Cambridge, MA)
- …Manager, Associate Director, Director ( Global Regulatory Lead (GRL)), in the development and execution of the regulatory strategy . Assigned matters may have ... contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development , Legal, and others such as Commercial. Functions… more
- Bristol Myers Squibb (Cambridge, MA)
- …of early drug development . Early Clinical Development drives clinical development strategy , design, execution, and interpretation of clinical ... Development - HOCT function is part of a global organization dedicated to the effective design and execution...trials from Phase 1 through Proof-of-Concept by + Articulating clinical development strategy + Analyzing,… more
- Astellas Pharma (Cambridge, MA)
- **Head of Solid Tumor Clinical Development ** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we ... and implementation of the Oncology Solid Tumor franchise strategy in alignment with the overall Oncology Development...all work products of the team, ensuring efficiency in clinical development planning and execution and embedding… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …interacting with regulatory authorities + Experience in global pharmaceutical development and lifecycle management including clinical development , ... is responsible for providing critical support in developing global regulatory strategy , planning, and execution of...Clinical Trial Application projects in alignment with the Global Regulatory Lead (GRL). + As an integral member… more
- ThermoFisher Scientific (Waltham, MA)
- … development experience, including experience with early and/or late phase clinical development strategy and understanding of regulatory environment + ... clients to design and implement product development strategy on both local and global levels....Project lead for a team of experts in regulatory strategy , product development , biostatistics, clinical … more
- Sanofi Group (Cambridge, MA)
- …teams to provide robust commercial direction on pipeline planning and product development strategy and ensure appropriate early commercial planning and ... Head of New Product Planning (NPP) and TA Strategy , Immunology reporting to the Global Franchise...commercial leadership and strategic direction on products moving from pre- clinical stages through early development and towards… more
- Merck (Boston, MA)
- …US scientific leader (SL) field insights, facilitating local pull-through of global strategy and consulting on the development and execution of aligned local ... (ED/TL), the SDMA is responsible for regional Field Medical strategy and prioritization of Global Plans for...Training (GST), Global Scientific Content (GSC), US Global Clinical Trial Organization, (GCTO), GMSA TA… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …The Senior Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, ... from various disciplines to create, maintain, and execute a global clinical development plan that...that activities are aligned with the global strategy . + Establishes and drives Development Team… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …. The Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, ... from various disciplines to create, maintain, and execute a global clinical development plan that...that activities are aligned with the global strategy . . Establishes and drives Development Team… more
- Takeda Pharmaceuticals (Boston, MA)
- …of the Integrated Disease Area Strategy (IDAS) and overall Integrated Global Development Plan (IGDP). Responsible for review of synopses, other relevant ... on assigned clinical studies. + Leads the Global Development Team (US, EU, and others)... Team strategy and deliverables overseeing the Development Strategy , Clinical Development… more