- Sanofi Group (Cambridge, MA)
- **Job Title:** Early Development Global Study Leader **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ready to shape the future of ... be critical in helping our teams accelerate progress. The Global Study Leaders plan, execute, and finalize...study timelines + monitor the progress of the studies , identifying risks and issues, develop mitigation plans, conducting… more
- Takeda Pharmaceuticals (Boston, MA)
- …organization, including 4+ years clinical study management/oversight. Experience must include either early phase clinical studies or Phase 2 and 3 studies ... you to shine? Join us as a Lead Clinical Study Manager based remotely reporting to the Clinical Operations...towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work… more
- Bristol Myers Squibb (Cambridge, MA)
- …research plans in support of asset strategy with the Early Clinical Development Leadership team; Clinical studies include first-in-human Phase I, proof of ... autoimmune indications. Physician-scientists and clinical-scientists within this group oversee the early development of both internal and partnered assets… more
- Bristol Myers Squibb (Cambridge, MA)
- …analytical approaches * Actively engage with stakeholders across R&D, including Research & Early Development (R&ED) and Global Drug Development ... drug development across therapeutic areas. The ideal candidate will support early and late-stage clinical drug development across therapeutic areas by… more
- Bristol Myers Squibb (Cambridge, MA)
- …mechanistic data with proven track record of publications + Understanding of early or late-stage drug and translational development process; including experience ... . The Senior Principal Scientist role will be responsible for development and execution of myeloma asset centric translational strategies in hematology… more
- Sanofi Group (Cambridge, MA)
- …integrated safety review** + Provide expertise on translational safety science for early development projects to ensure translation of non-clinical and emerging ... clinical toxicology expertise to support the design of the early non-clinical proof of concept studies to... in at least one of the following areas: early development , safety, risk management, pharmacoepidemiology or… more
- Takeda Pharmaceuticals (Boston, MA)
- …serious and unmet diseases, resulting in a high impact to research and early development , clinical development pipeline, and marketed products. ... analyses and complex analyses of real-world data in support of study /protocol design and evidence generation activities within Global Evidence… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …a CNS portfolio Global Medical strategy is in place, including among early phase assets, and help dictate priorities and resources for the function. Leading a ... **Position Summary** : Reporting to the Vice President, Global Medical Affairs, the Executive Director, CNS Strategy,... CNS evidence generation with Phase IIIB and IV studies , including Investigator Sponsored Studies and non-interventional… more
- Sanofi Group (Cambridge, MA)
- …to provide labeling input relevant to clinical study protocols, especially in early and late development phases. + Contribute to discussions around clinical ... requirements and Sanofi's product positioning. The Associate Director contributes to early development activities by providing regulatory input into clinical… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …to the best of my knowledge. **Job Description** **Primary Accountabilities:** + Leads development and execution of multi-year global medical strategy for the ... of mezagtiamab and other pipeline assets. + Responsible for development execution of Global Medical plans and...the TA. + Leading design and execution of clinical studies with Global Medical Evidence (phase IIIb/IV,… more
- Sumitomo Pharma (Boston, MA)
- …compliance with GCP standards. + Develop and execute corporate clinical strategy for global development projects in Oncology + Monitor clinical trial progress, ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory, Early Clinical Development , Pre-clinical research, Medical Affairs… more
- Takeda Pharmaceuticals (Boston, MA)
- …and best-practice sharing workshops + Partner with Pricing to lead the development of the global pricing strategies for Hematologic-oncology brands through ... experience in health technology assessment tools, methods and filings, payer and global pricing research, price modelling and cost-effectiveness studies + Prior… more
- Sanofi Group (Cambridge, MA)
- …and scientific expertise to the cross functional project team to conduct the clinical studies from early phases to LCM programs + Establish clinical ... documentation for the project(s), provide clinical leadership to other operational development activities pertaining to study start-up (eg pressure test,… more
- Lilly (Boston, MA)
- …of research results. **Clinical Study Execution** + Provide medical leadership in early development study conduct including study design, safety ... part of the multidisciplinary team, to support dose selection, PK/biomarker strategy across early development phases + Comply with local laws and regulations,… more
- Merck (Boston, MA)
- …for the Senior Principal Scientist include the following:** + Key member of an early development team, providing leadership in designing and executing early ... Medicine studies to establish and/or validate novel clinical biomarker platforms. + Development and execution of the early clinical development strategy… more
- Takeda Pharmaceuticals (Boston, MA)
- …leadership for development ADME activities from candidate nomination through IND-enabling studies and regulatory submissions (eg, IND, NDA, BLA). + Serve as the ... studies . + Drive continuous improvement initiatives by optimizing development ADME processes and promoting scalable, agile, and sustainable operations. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …values. Competencies: + Deep oncology experience through Phases I-IV. + Managing large complex global studies . + Expert knowledge of global regulatory and ... as the Executive Director of Clinical Operations reporting to the Head of Global Clinical Development Operations. At Takeda, we are transforming the… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …medical oversight of early phase studies and oversee protocol development and study execution in collaboration with cross functional stakeholders + ... Otsuka's culture and values and will support Discovery and Early Development activities for Jnana Therapeutics, an...any internal or external scientific communication related to clinical studies or mechanism of action of the study… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …plans and provide input on modeling and simulation activities. You will interact with early development and business development team members and external ... assess/lead development and selection of pre-IND and early phase assets. **Job Description** + Serve as **clinical...packages **.** + Lead **clinical pharmacology** activities related to study design, protocol development , study … more
- Takeda Pharmaceuticals (Boston, MA)
- …Translational Sciences (NTS) Team plays a pivotal role in supporting programs from early development to market authorization by being accountable for innovation ... and early discovery, non-clinical development , translational & biomarker...to work in matrix organization by collaborating with cross-functional global development teams. **_DIMENSIONS AND ASPECTS_** +… more