- Merck & Co. (Boston, MA)
- …of Phase I studies ; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, ... insight into the earliest stages of target identification and validation, and executing clinical studies to evaluate the relevance of potential targets to human… more
- Statistics & Data Corporation (SDC) (Waltham, MA)
- …to help guide and develop the more junior biostatistics staff members. Serve as a lead statistician on clinical studies and provide senior level peer review ... of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical… more
- Merck & Co. (Boston, MA)
- … clinical bioanalysis.Required Skills: Anatomic Pathology, Biomarker Development, Clinical Studies , Digital Pathology, Molecular PathologyPreferred Skills: ... Molecular Biomarkers is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases of … more
- Synterex (Boston, MA)
- …managing major submissions Familiarity with the requirements for preparation of key clinical and regulatory documents, including ICH and US /EMA regulatory ... Writer Synterex, Inc. is a global consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and … more
- Sanofi Group (Cambridge, MA)
- …individual will also serve as Study Medical Manager (SMM) for selected clinical studies . SMM principal duties and responsibilities include:** Study ... **Job Title:** Clinical Lead , Early Clinical ...Dose Escalation Meeting and document decision making (for First-in-Human studies ). + Review the Adverse Event reports. Study… more
- Parexel (Boston, MA)
- **Job Summary:** The Clinical Study Lead (CSL)...studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug ... versus oversight will vary accordingly. **Key Accountabilities:** + Leads the cross-functional study team responsible for clinical study delivery and… more
- Sanofi Group (Waltham, MA)
- …of robust immunologic, virologic, and bacteriologic assays that meet ICH guidelines to support clinical studies + Support and coordinate all clinical testing ... **Job Title:** Clinical Immunology Lead - Vaccines **Location:**...+ Project management and computer skills required **Why Choose Us ?** + Bring the miracles of science to life… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …inspire you and empower you to shine? Join us as Director, Quantitative Clinical Pharmacology (QCP) Lead in our Cambridge, MA office. Our Data and ... + Provides scientific and strategic leadership as the Global or Regional Clinical Pharmacology Lead for multiple projects on Global Program Teams… more
- Parexel (Boston, MA)
- **Job Summary:** The Senior Clinical Study Lead (SCSL) is accountable for the support of global execution of assigned large and/or complex clinical ... studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug...without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender… more
- Parexel (Boston, MA)
- …of contact for resolution. * Maintain and review metrics related to clinical study samples, data, kits, and logistics. * Lead cross-functional study ... is required. The candidate will develop, drive, and handle clinical study related tasks for the team...and issues with an awareness of the impacts to clinical studies /program. * Strong problem-solving, project management,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Provides scientific and strategic leadership as the Global or Regional Clinical Pharmacology Lead for multiple projects on Global Program Teams ... knowledge and experience with design, analysis, and reporting of clinical pharmacology studies . + Specialized clinical...or local minimum wage requirements for the job location. US based employees may be eligible for short-term and/… more
- Roche (Boston, MA)
- …plans that deliver medically-differentiated therapies providing meaningful improvements to patients. As **( Lead ) Clinical Director** , you will play a pivotal ... development, research, commercial, and legal. + Provide Late Stage clinical science input into early development/Phase I studies...shaping the future of metabolic healthcare!** If you are US based, then please apply for a role within… more
- Sanofi Group (Cambridge, MA)
- …of vendors, Vendor Excellence SMEs, Clinical Operations Project Lead , Clinical Operations Study Lead , Procurement and other relevant departments. ... deal with frequent changes, delays or unexpected events in clinical studies . Strong ability to **Act for...study documents, internal & external communications. **Why Choose Us ?** + Bring the miracles of science to life… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Senior Clinical Outcomes Assessment (COA) Lead **Location:** Cambridge, MA, Morristown, NJ **About the Job** Are you ready to shape the future of ... helping our teams accelerate progress. The remit of the Clinical Outcome Assessment (COA) team at Sanofi is to...Ready to get started? **Main Responsibilities:** + The **COA Lead ** is accountable for the definition of COA endpoint… more
- Roche (Boston, MA)
- …the future of clinical development in metabolism, obesity, and diabetes? As a **( Lead / Senior) Clinical Development Scientist** , you'll play a key role in ... the entire portfolio. In this role you will: + Lead the clinical science strategy and execution...late-stage programs. + Conduct medical and safety data reviews, study design, and protocol development, ensuring alignment with strategic… more
- Parexel (Boston, MA)
- …**(CSAM)!** The Clinical Study Associate Manager (CSAM) Service supports the Clinical Study Lead by taking responsibility for areas of clinical ... (SOPs) and ICH/GCP. This Service applies to internally sourced studies and studies out-sourced to Clinical...regular status reports to stakeholders as requested by the Clinical Study Lead + Contributes… more
- Parexel (Boston, MA)
- …of one or more studies across a program. The CSS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The ... CSS will support internally sourced studies and studies out-sourced to ...Organizes and delivers analyzable reports and metrics to the clinical study lead + Schedules… more
- Sanofi Group (Cambridge, MA)
- …select Exploratory Pharmacology studies ) and/or registries (eg: protocol, Key Results, Clinical Study Report) + Support other clinical development ... medical information for the study team, medical advisors/ Clinical Project Leaders from Clinical Study...medical spokesperson for the studies and project Lead the strategy and structure of the clinical… more
- Bayer (Cambridge, MA)
- …**Location:** United States : Massachusetts : Cambridge **Division:** Pharmaceuticals **Reference Code:** 854170 **Contact Us ** **Email:** hrop_###@bayer.com ... as Study Medical Expert for dedicated early clinical development studies or clinical ...plan in partnership with other functions and the Global Clinical Lead (GCL), with input from and… more
- Sumitomo Pharma (Boston, MA)
- …**Job Duties and Responsibilities** + Responsible for and lead all activities related to clinical study design from clinical study concept to ... highly complex decisions + Leads and drives strategy for clinical studies for assigned asset(s) within the... clinical trial results and the writing of clinical study reports + Contributes to the… more