- Pfizer (Cambridge, MA)
- …the way in healthcare and make a lasting impact on society. **What You Will Achieve** As a Clinical Study Group Lead , you will be an operational and ... 5 submission subteams and endgame inspection readiness. In the Clinical Study Group Lead... studies + Accountable to deliver excellence in clinical study team leadership for a portfolio… 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
- 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
- Philips (Cambridge, MA)
- ** Clinical Development Scientist (Cambridge, MA)** The Clinical Development Lead will primarily focus on study design strategy for the development of ... and associated data collection activities, within the Hospital Patient Monitoring business group + Defining clinical questions, study end-points, identifying… 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
- 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
- Pfizer (Cambridge, MA)
- …Intake processes to optimize efficiency and compliance with regulatory requirements. + Lead and manageaudits within the Study Organization (SO), including ... (R&D) engine providing analytics & intelligence to customers and stakeholders across clinical and regulatory functions within PRD & POD. The Site Intelligence,… 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
- 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 ... strategies. + The role will bring in-depth knowledge of clinical studies , ensuring that medical plans and... studies including observational, prospective, and claims database studies , and knowledge of study analyses plans… more
- Sanofi Group (Cambridge, MA)
- …contribution and/or approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data ... plans, study reports, integrated summary of safety, summary of clinical safety, and labeling + Review, preparation, and/or contribution to questions from… more
- Sanofi Group (Cambridge, MA)
- …and Finances to facilitate financial exercises throughout the year, for both tactics and Clinical Studies + Study Prioritization process: + CSS SRC approval ... individual will work closely with his/her respective Medical Program Lead (MPL) and TA Global Medical Team (GMT), both...study data milestones and budget specific to all studies defined in the approved iEGP + Compliance reporting… more
- Sanofi Group (Waltham, MA)
- …technology! As an experienced mRNA Process CMC Senior Principal Statistician, you will lead and coordinate the team providing statistical support to the mRNA CoE ... brings end to end data integration and advanced analytics (pre- clinical , biomarkers, process development, CMC, clinical ) in...in platform and project technical teams as statistical CMC lead and subject matter expert and develop and drive… more