- Merck & Co. (Rahway, NJ)
- …Director, PDT Lead will manage the entire cycle of clinical development, including development strategy, study design, initiation, execution, monitoring, ... safety and efficacy as well as new drug applications, clinical study reports, or publicationsParticipation in internal...entire Clinical Teams in the execution of clinical studies .--Will report to and work collaboratively… more
- Merck & Co. (Rahway, NJ)
- …offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to ... enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced leadership team, deep modeling… more
- Merck & Co. (Rahway, NJ)
- …outlined in applicable regulationsAnalysis of peer-reviewed literatureReview of clinical study dataParticipation in risk communication planningParticipation ... Acceptance Tests (UATs) for functionality changes)Perform literature searchesFunction as Content Lead for one or more GPV sub-teams (eg, training, risk management,… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Specialist to manage sample data processes and biobanking operations for Oncology clinical studies and research initiatives. Responsible for leading clinical ... we believe there is a lot of opportunity to lead in this growing group . This role...ROLE LOOKS LIKE: + Responsible for the interpretation of clinical /non- clinical study protocols and associated… more
- Bristol Myers Squibb (Summit, NJ)
- … 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
- Merck (Rahway, NJ)
- …Director, PDT Lead will manage the entire cycle of clinical development, including development strategy, study design, initiation, execution, monitoring, ... safety and efficacy as well as new drug applications, clinical study reports, or publications + Participation...entire Clinical Teams in the execution of clinical studies . + Will report to and… more
- Mount Sinai Health System (New York, NY)
- …per specifications of the protocol; and monitors test results, as appropriate Documents clinical study and therapy in patient's chart and all other databases ... provides clinical support and administrative direction for the Multiple Myeloma group within the Tisch Cancer Institute's Clinical Research Support Unit (TCI… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …Director of the Medical Science Early-Stage, the Director, MSES will lead clinical and scientific aspects of Early Development studies from Phase 0 through ... for successful execution, analysis, interpretation of results of early-stage clinical studies . + Leads or participates in...+ Prepares and/or directs the preparation and review of study protocols, clinical study reports… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Biostatistics, such as team capability development. **RESPONSIBILITIES:** + Acts as biostatistics lead on clinical studies or other non-molecule projects. ... providing statistical consultation on clinical development plans, clinical trial design and clinical study... endpoints and authors statistical analysis plans. Typically assigned clinical studies or other projects of increasing… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …a hands-on culture so responsibilities will include support to some clinical study activities. The candidate will also supply, lead and/or supervise IND/CTA ... within Regeneron's Genetic Medicine Portfolio. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … clinical and health economic literature, including disease state information, clinical trial design and results, and Pharmacoeconomics studies , in order ... (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, supply chain,and business development… more
- ManpowerGroup (Rahway, NJ)
- …Under the general direction of the Patient-Centered Endpoints & Strategy (PaCES) group lead , the Associate Principal Scientist has responsibility for ... ) of **COA/PRO** development, **_validation, electronic migration and interpretation_** into ** clinical trial and observational studies ** . + Ability to… more
- ManpowerGroup (Rahway, NJ)
- …Under the general direction of the Patient-Centered Endpoints & Strategy (PaCES) group lead , the Associate Principal Scientist has responsibility for ... interpretation) of COA/PRO development, validation, electronic migration and interpretation into clinical trial and observational studies . Ability to understand… more
- Bristol Myers Squibb (Summit, NJ)
- …effective risk and issue management. Provide quality and compliance consultation to clinical trials teams throughout study lifecycle and establish a feedback ... be responsible for developing the Quality Narrative at the study and/or ASSET and TA levels to document end-to-end...teams; serve as part of strategic team(s) within the group /discipline. * Lead and/or contribute to the… more
- Bristol Myers Squibb (Summit, NJ)
- …and clinical protocols using data and information from discovery phase, non- clinical and clinical studies + Oversee process development, manufacturing ... teams; serve as part of strategic team(s) within the group /discipline . + Lead and/or contribute to...Escalation Process + Ensure GLP systems are in place, studies are audited and lead analytical path… more
- IQVIA (New York, NY)
- …project responsibilities at the level of technical team lead for single complex studies or group of studies . + Directly communicate with internal and ... and theory. + Excellent application development skills. + Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …to understand the way our drugs are working, but also to inform and influence clinical trial study design. **As a Principal Scientist in the Cancer Immunology ... team contributes to discovery and development of novel therapeutics in the Cancer Immunology group at Regeneron. You will join a fast pace growing team that develops… more
- Medtronic (New York, NY)
- …and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, ... quotas by driving product adoption through the delivery of clinical and economic value of Medtronic AI platforms +...basedon business strategy with a significant impact on work group results. Excellence in Medtronic GI portfolio integration into… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …method procedures with few or no subsequent edits for review by supervisor and/or Study Director + Takes the lead /supervisory role in planning of validation ... Regeneron's Assay Development Group (ADG), located in Tarrytown NY, is seeking...perform sample analysis, if needed + May function as Study Director for assay validation studies conducted… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …development that may include candidate screening and selection for preclinical and Phase 1 clinical studies , developing formulations for Phase 2/3 clinical ... We are seeking a highly motivated Senior Scientist within the Formulation Development Group (FDG) of Regeneron Pharmaceutical Inc. at Tarrytown, NY. In this exciting… more
