- Pfizer (Cambridge, MA)
- …way in healthcare and make a lasting impact on society.** **What You Will Achieve** As a Clinical Study Team Lead (CSTL), you will be an integral member ... team delivery of multiple complex global studies and/or programs. Your clinical development expertise...operations + Accountable for issue escalation and resolution + Lead study team chartering and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …contributor to our inspiring, bold mission. **_GOALS:_** + Under the direction of the Global Clinical Supply Chain (GCSC) Team Lead , the Clinical ... you to shine? Join us as a Manager, Global Clinical Supply Chain Operations Lead in Lexington,...defined change management processes. Manage all finance activities with clinical team including request for proposal for… more
- Sanofi Group (Cambridge, MA)
- …Advance the CDP through internal management review + Lead a clinical sub team to design clinical studies , create an abbreviated and full clinical ... the lunsekimig project team , as well as study execution in close collaboration with clinical ... study protocol + Oversee the execution of clinical studies in compliance with internal SOPs,… more
- Sanofi Group (Waltham, MA)
- …vaccine development candidates they oversee. **About you** + You will lead the clinical study team and as such requires leadership skills, communications ... job** This role in the Meningitis Franchise will provide clinical and R&D expertise and lead one...clinical leadership in the design and development of clinical studies and programs for Sanofi Vaccines… more
- Pfizer (Cambridge, MA)
- …etc.), and lead translation of pre- clinical observations into clinical experiments and studies designed to demonstrate proof of pharmacology, proof ... **ROLE SUMMARY** The Clinical Lead (CL), Internal Medicine RU...of clinical research plans into efficiently delivered studies . Creative in the conception of novel study… more
- Sanofi Group (Waltham, MA)
- …meetings, communications, CTD submissions) **About you** + You will lead the clinical study team and as such require leadership skills, communications ... clinical leadership in the design and development of clinical studies and programs for Sanofi Vaccines...ownership for the Clinical Strategy, the respective Clinical Development Plans (CDP) and study protocols… more
- Boston University (Boston, MA)
- The BU CTE Center seeks a Study Coordinator to lead efforts on their new NIH/NINDS-funded project: Risk and Resilience, Clinical presentation, and Biomarker ... Research Program Manager to: manage regulatory documents, communication with IRB and study sponsors, screen, and recruit study participants, conduct diagnostic… more
- Bristol Myers Squibb (Cambridge, MA)
- …plan for complex programs that have a large impact on the business. Ensures clinical studies are aligned with target label indications and are designed to ... commitment to our People Strategy + Serves as the clinical point of accountability for the Development Team...studies , with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication +… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Global Head of Clinical Research and collaborates closely with the leadership of Clinical Affairs to lead clinical strategy activities and oversee all ... aspects of clinical studies in support of clinical evidence generation...the Respiratory business unit. + Oversees all aspects of Clinical Study Management within the Respiratory business… more
- Pfizer (Cambridge, MA)
- … oversight - in collaboration with Scientific Affairs Lead , and other operational study team members, provide clinical guidance and oversight during the ... clinical protocol training materials to internal and external study team members. Ensures proper compliance and...clinical and operational content for clinical study reports and publications as appropriate. Lead … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …these activities, and is accountable for the successful design and interpretation of clinical studies . Presents study conclusions to Management and determine ... Development Team for a given product. May lead the US/EU Development Teams and represents Clinical...Previous experience successfully leading a clinical development team /matrix team with responsibility for studies… more
- Bristol Myers Squibb (Cambridge, MA)
- …plans in support of asset strategy with the Early Clinical Development Leadership team ; clinical studies include first-in-human Phase I, proof of concept ... primary source of medical accountability and oversight for multiple clinical trials + Manages Phase I/II studies ,... Scientists to allow for protocol-specific training, supporting the study team , investigators, and others + Ad-Hoc… more
- J&J Family of Companies (Boston, MA)
- …platform, including clinical studies , data science and new clinical and physiological applications. **Key Responsibilities:** + Study start-up and ... study progress and activities. + Partner with cross-functional team (eg, clinical data management, medical teams)...Lead in the investigation of all discrepancies in study documentation, by applying clinical protocol knowledge… more
- Dana-Farber Cancer Institute (Boston, MA)
- …and will support the research team in the overall conduct of specimen-based clinical research studies using Good Clinical Practice under the auspices of ... monitoring visits. + Coordination and management of specimen-based clinical research studies , including communication with Sponsors,...study participants as directed/required by the protocol and/or study team . + May be responsible for… more
- ThermoFisher Scientific (Waltham, MA)
- … study plans/reports for inclusion into the project Design History File (DHF). + Lead all aspects of clinical study execution on assigned projects, ... to project core teams. + Work closely with core team and Regulatory Representative during the study ...monitoring, and eTMF completion. + Facilitate internal and external clinical studies preparation and planning meetings. +… more
- Sanofi Group (Cambridge, MA)
- …+ Owns (in collaboration with Project Team ), the "Abbreviated protocol" for individual studies , the clinical sections of BLA, CDP and the clinical ... the registration of a product, directly reporting to the Clinical Lead in charge of the ...the Abbreviated Protocol and Protocol development + Represents the clinical function on Clinical Study … more
- Bristol Myers Squibb (Cambridge, MA)
- …for a group of studies + Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical ... Development Expertise & Strategy + In collaboration with the Clinical Development Lead , designs and develops ... Scientists to allow for protocol-specific training, supporting the study team , investigators, and others Health Authority… more
- Schrodinger (Cambridge, MA)
- …we do **What you'll do:** + Oversee, lead and matrix manage cross-functional study team , external service providers (CROs, vendors, etc.), and clinical ... join the New York-based Early Clinical Development team . This hire will oversee study management...in compliance + Account for all operational aspects of clinical studies , including management of external service… more
- Takeda Pharmaceuticals (Boston, MA)
- … for assigned compounds. In some cases may lead the US/EU Development Team but more likely will oversee the clinical scientist responsible for leading this ... **Synopsis / Protocol Development, Study Execution, & Study Interpretation** + Drives all Clinical Science...Previous experience successfully leading a clinical development team /matrix team with responsibility for studies… more
- Regeneron Pharmaceuticals (Boston, MA)
- … development program strategies, author clinical development protocols and facilitate/ lead execution of study activities and data summarization. As ... the relevance and accuracy of medical science underpinning the clinical study , based on thorough scientific review...for activities and procedures that ensure patient safety, ensures Clinical Team compliance with FDA, EMEA, ICH… more