- Philips (Cambridge, MA)
- ** Clinical Validation Lead (Cambridge, MA)** You will be part of a Breakthrough Innovation Team (BRITE) in the Innovation & Strategy Department reporting to ... stage to full ability to scale. **Your role:** + Lead design validation activities to ensure that...You have an affinity for (complex) medical devices and pre- clinical and clinical validation methods.… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Clinical Lead , I&I **Location** : Cambridge, MA or Morristown, NJ **About the Job** Are you ready to shape the future of medicine? The race is on ... be critical in helping our teams accelerate progress. The Clinical Lead is the **primary clinical...development, pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment… more
- Bristol Myers Squibb (Cambridge, MA)
- …the late stage TM group. The individual will be a translational team lead for neurological and neuropsychiatric indications and be responsible for setting strategy ... for translational activities including clinical biomarker activities to support drug development programs. This...support drug development programs. This individual will assume translational lead responsibilities for assets such as serving as a… more
- Takeda Pharmaceuticals (Lexington, MA)
- …processes + Review and approve user requirements, design specifications, and verification/ validation plans + Maintain traceability between clinical needs and ... and commercial functions + Coordinate interdepartmental initiatives to optimize device clinical development timelines **Process Innovation:** + Lead initiatives… more
- Sanofi Group (Cambridge, MA)
- …Senior Clinical Research Director (Sr CRD) is noted as the **primary clinical lead for programs** . The role requires a well-organized, strategic focused, ... (eg pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment)...as the medical spokesperson for the studies and project Lead the strategy and structure of the clinical… more
- Sanofi Group (Cambridge, MA)
- …Principal Clinical Research Director (CRD) is noted as the primary clinical lead for complex priority projects, especially those with multiple indications. ... activities (eg pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment) + Contribute to the clinical… more
- Sanofi Group (Cambridge, MA)
- …subject matter expert on key topics, and can serve as back-up for the Clinical Innovation Operations Portfolio Lead for some activities spanning the Portfolio. A ... as relevant. Digital Biomarker Operational Leads report into the Clinical Innovation Operations Portfolio Lead and work.../program's need + Facilitate the development of Digital Biomarkers validation plan as needed and connect the clinical… more
- Bayer (Cambridge, MA)
- …**YOUR TASKS AND RESPONSBILITIES** The primary responsibilities of the Integrated Product Medical Lead are to: + Acts as the clinical leader and primary ... clinical strategy; + Supports the preclinical evaluation and validation of new oncology assets in line with the...within as well as outside of Bayer, to drive clinical excellence; + Can lead and drive… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …novel technologies, and incorporation of biomarker endpoints for decision-making in early-stage clinical trials. + Lead Translational subteam (TST) and provide ... for clinical development and overall asset strategies. + Implement fit-for-purpose validation for all clinical biomarker assays with BST and ensure high… more
- Eurofins (Cambridge, MA)
- …Duties: + Perform complex GMP assays (PCR, ELISA, NGS, cell-based assays) + Lead method transfer, qualification, and validation for bioassays + Author/review ... discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. If you're looking for a rewarding career, apply with us… more
- Bristol Myers Squibb (Devens, MA)
- …BioPharma Operating Units, the Sr. Director, BI&T, Devens Digital Plant and Site BI&T Lead will be directly accountable to the US Biologics Leader and Devens Campus ... and support operations of the site - to include Commercial and Clinical biologics drug substance manufacturing, site Product Development, and laboratory operations.… more
- Lawrence General Hospital (Methuen, MA)
- Holy Family Hospital is offering a $12,000 sign-on bonus for a Lead Medical Technologist. Join us at Holy Family Hospital Our two campuses in Methuen and Haverhill ... Knee and Hip Replacement. As the Holy Family Hospitals Lead Medical Technologist, you will assist the Core Lab...policies. + Interacts professionally with the Manager of the Clinical Laboratory, Pathologist, and clinical laboratory personnel.… more
- Bristol Myers Squibb (Devens, MA)
- …Cell Therapy team. BMS Cell Therapy Manufacturing seeks a **Specialist, Lead Manufacturing Associate Cell Therapy** that brings enthusiasm, intellectual curiosity, ... their work. + Completes documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Solves… more
- Bristol Myers Squibb (Cambridge, MA)
- …medicinal chemistry, DMPK, preclinical safety, pharmacology, translational research, and early clinical development. The candidate will lead efforts to ... molecule assets. + Leverage current and new biological techniques for target validation , assay development, hit identification and lead optimization and… more
- Bristol Myers Squibb (Devens, MA)
- …QC Instrument Specialist** **, Bristol-Myers Squibb Company, Devens, MA.** Lead qualification of quality control analytical instruments and other lifecycle ... activities. Design, manage, and implement applicable validation documents, such as test scripts, User Requirement Specification, Design Qualification, validation … more
- Pfizer (Cambridge, MA)
- …**Role Responsibilities** Successful candidates will be expected to: + Apply scientific and clinical expertise to the identification and validation of new drug ... excellent communication and interpersonal skills, and the ability to lead and work as part of a team are...renal disease biomarkers in nonclinical studies that enable their validation for clinical application. + Demonstrated ability… more
- Takeda Pharmaceuticals (Lexington, MA)
- …through clinical development, product registration and commercialization. Own and lead the creation of design control deliverables to comply with medical device ... knowledge. **Job Description** **Primary** **Role:** The Staff Device Engineer will lead technical efforts for combination products and drug delivery device projects… more
- Nanobiosym, Inc. (Cambridge, MA)
- …business and regulatory expectations. * Ensure the timely and compliant generation of clinical and validation data required to support regulatory submissions for ... Testing CLIA LAB. The role and requirements are below. The CLIA ( Clinical Laboratory Improvement Amendments) Quality Manager will provide quality and compliance… more
- Bristol Myers Squibb (Devens, MA)
- …ensures effective implementation of quality lifecycle strategies for cell therapy commercial, clinical and development products. + Acts as lead Quality ... implementation of all quality and compliance life cycle strategies for development, clinical and marketed cell therapy products including cell therapy cell banks,… more
- Cytel (Cambridge, MA)
- …(SDTM & ADaM) to support or lead one or more Early or Late stage clinical trials. **This role is Hybrid office based in PA (Preferred) OR NJ** . **Our values** + ... all therapeutic areas. + Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming +… more