- 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 (Cambridge, 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
- 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
- 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
- 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 (Cambridge, MA)
- … Clinical Study Units, and investigators + Be the medical reference in the Clinical Study team , ensuring the medical relevance of the clinical ... studies ) and/or registries (eg: protocol, Key Results, Clinical Study Report) + Support other ... lead + Provide operational expertise to project clinical sub team , as needed **Responsibilities related… more
- Pfizer (Cambridge, MA)
- …and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation ... Early Stage Clinical Scientist (ESCS) is to lead and coordinate the development of multiple studies...the project team , to meet enrollment and study delivery timelines. The Early Stage Clinical … 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
- Takeda Pharmaceuticals (Boston, MA)
- … leadership and Project Team / Clinical team membership + Leads clinical teams as Global Clinical Lead or represents Clinical Science on ... Global Project Team to ensure that the clinical team activities are aligned with the.../ approval of Synopses, Protocols and the conduct of clinical studies . Serves as an advisor or… more
- Sanofi Group (Cambridge, MA)
- …select Exploratory Pharmacology studies ) and/or registries (eg: protocol, Key Results, Clinical Study Report) + Support other clinical development ... feasibility, medical review of data, medical information for the study team , medical advisors/ Clinical Project...medical spokesperson for the studies and project Lead the strategy and structure of the clinical… 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
- 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
- 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
- Pfizer (Cambridge, MA)
- … Lead (and members of the development team ) to establish, lead , coordinate, and execute the early oncology clinical development plan(s) for one ... signals of efficacy (ESOE) and proof of concept (POC) studies . + *The OES Clinical Scientist (Senior...protocol and may participate as an individual contributor on clinical study teams and clinical … more
- Sanofi Group (Cambridge, MA)
- …collaboration with biostats. + Responsible for key results preparation. + Develop the Clinical Study Report (CSR). + Contribute to briefing packages for ... as well as applicable standard operating procedures (SOPs). + Lead the study specific committees, eg, Independent...expertise in clinical development and methodology of clinical studies . + Excellent communication skills (verbal… 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
- 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
- Pfizer (Cambridge, MA)
- …excellence in support of strategic imperatives and in collaboration with the cross functional study team (s) + Ensure work carried out by or on behalf ... consistency in asset/submission data. **KEY RESPONSIBILITIES** + Serve as Clinical Data Scientist and Trial Lead for...clinical trials and ability to assess and determine study requirement from protocol review + Strong Project and… 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