- Sanofi Group (Cambridge, MA)
- …select Exploratory Pharmacology studies ) and/or registries (eg: protocol, Key Results, Clinical Study Report) + Support other clinical development ... Research Director (Sr CRD) is noted as the **primary clinical lead for programs** . The role...medical input & support for all activities related to clinical studies such as medical training, feasibility,… more
- Sanofi Group (Cambridge, MA)
- …The role of the CRD is to: + Lead the conduct of the clinical study (ies) under his responsibility at both strategic and operational levels + Be responsible ... Raise study or project-level issues to the Clinical Lead and/or Project Head when needed...** Lead , Support and oversee the execution of clinical development and studies activities** + Develop… 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
- Takeda Pharmaceuticals (Boston, MA)
- …and validation at CROs and data delivery to support decision making in clinical studies and portfolio progression + BST Lead will lead Translational and ... is seeking a strong scientific leader to join the group as the BST lead to support...BLA, PMA, etc.), Briefing Book (BB), Investigatory Brochure (IB), Clinical Study Reports (CSR), study … more
- Sanofi Group (Cambridge, MA)
- …and their families. Your skills could be critical in helping our teams accelerate progress. The Clinical Study Unit (CSU) is the site facing arm of clinical ... is responsible for monitoring and enrolling patients into our clinical studies here at Sanofi. The individual...Engagement Leads, Local Innovation Leads, and a Monitoring Team. Clinical Study Units (CSUs) are our experts… more
- Sanofi Group (Waltham, MA)
- …for the vaccine development candidates they oversee. **About You** **Requirements:** + You will lead the clinical study team and as such requires leadership ... 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
- Takeda Pharmaceuticals (Boston, MA)
- …these activities and is accountable for the successful design and interpretation of clinical studies . Presents study conclusions to Management and determine ... a significant impact on timelines or product labeling. Plans clinical development plans or study designs that.../ approval of synopses, protocols and the conduct of clinical studies . Serves as an advisor to… more
- Bristol Myers Squibb (Cambridge, MA)
- … lifecycle ** Clinical Development Expertise & Strategy** + Designs and develops clinical studies and research plans in support of asset strategy with the ... new molecules, biomarkers, and mechanistic hypotheses in humans. The group drives early clinical strategy, and the...Early Clinical Development Leadership team; clinical … more
- Sanofi Group (Cambridge, MA)
- …datasets, medical imaging data, continuous data from wearable devices) collected from clinical studies for both formal reporting and exploratory analyses ... progress. The Statistical Biomarker Leader is involved in the clinical development process from early on to lead...concepts and techniques in various biomarker data collected in clinical studies + General knowledge of pharmaceutical… more
- Sanofi Group (Cambridge, MA)
- …for all clinical scientific operational activities related to the projects/ studies he/she is assigned to + Write/contribute/review/QC/validate study related ... provide clinical scientific expertise for:** + The clinical studies (except Clinical &...Clinical Sciences & Operations (eg: protocol, Key Results, Clinical Study Report). + Support other … more
- Children's Hospital Boston (Boston, MA)
- …development, and conduct of clinical research studies and on clinical research best practices + Works with study investigators and statisticians to ... of multiple clinical research projects. Serves as Clinical Research Study / Trial Manager for... / Trial Manager for one or more large, clinical studies + Collaborates and consults with… more
- Sanofi Group (Cambridge, MA)
- …safety, efficacy, and value of our products. + Lead the development of study protocols, statistical analysis plans, and clinical study reports. + Oversee ... as study management and publications. + Prior experience in clinical trials, RWE/Epidemiological studies including understanding of trial methodology,… more
- Bristol Myers Squibb (Cambridge, MA)
- …training Clinical Development Expertise & Strategy + In collaboration with the Clinical Development Lead , designs and develops clinical plans and ... targets + Provides oversight and medical accountability for a group of studies + Leads the analysis...reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study… more
- Novo Nordisk (Lexington, MA)
- …therapeutics + Provide clinical and scientific expertise in the design of studies , writing of protocols and other study and regulatory-related documents for ... value chain spans from early research to phase 1 clinical studies . Established as a Transformational Research...Early Clinical Development unit as the US/international clinical lead for several internal GNAT development… more
- Takeda Pharmaceuticals (Boston, MA)
- …mission. **_GOALS:_** + Develop strategy for technology selection and deployment across Clinical Studies in alignment with established Takeda SOPs & Policies, ... are met with the highest degree of quality. + Lead study level technology & vendor oversight...in preparing function for submission readiness and may represent Clinical Trial Tools & Technologies (CT3) group … more
- Merck (Boston, MA)
- …the activities of Clinical Scientists in the execution of clinical studies . + Work closely with a cross-functional group of experts in commercialization, ... trials for investigational drugs + Analyzing and summarizing the clinical findings from studies to support decisions...safety and efficacy as well as new drug applications, clinical study reports, or publication; and +… more
- ThermoFisher Scientific (Waltham, MA)
- …the development of research questions and study design for epidemiologic studies using observational data from our clinical registries. Specifically, this ... development and delivery of life-changing therapies. As part of our clinical research portfolio, our CorEvitas evidence-based solutions specialize in generating data… more
- Sanofi Group (Cambridge, MA)
- …phase 3b and phase IV clinical studies , including informing clinical development plans and study designs to ensure differentiating and relevant outcomes ... lead in patient and scientific knowledge to enhance clinical care. We curate patient and scientific evidence and...launch readiness. The role will bring in-depth knowledge of clinical studies , ensuring that medical plans and… more
- Schrodinger (Cambridge, MA)
- … programs as a member of the cross-functional asset development teams and leader of clinical study teams. The Early Clinical Development (ECD) team supports ... clinical proof of concept and includes a cross-functional group of experts responsible for clinical sciences,... clinical safety and efficacy data, and write clinical study reports, clinical sections… more
- Sanofi Group (Cambridge, MA)
- …relevant statistical matters: + Provide high quality input into the design of the clinical study (including protocol development), the setup and conduct of the ... development. As Associate Statistical Project Leader, you will lead several oncology early phase projects or late phase...into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to… more