- 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
- Sanofi Group (Morristown, NJ)
- …results + Comply with company standards & local regulations Design and Oversee Clinical Studies + Be the strategic lead in the development of clinical ... oversight and approval of the protocol, Key Results Memo, Clinical Study Report and for other ...medical input & support for all activities related to clinical studies such as medical training, feasibility,… more
- Bristol Myers Squibb (Madison, NJ)
- …members of the study team for the day-to-day oversight and conduction of the clinical studies included in the BOW for an asset in the Cell Therapy portfolio. ... manages the evidence generation for the CT portfolio (including Medical Affairs Sponsored studies [MAST]) and provides clinical support for other studies … 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
- Sanofi Group (Morristown, NJ)
- … Programs** - Serve as the medical lead for switch programs and clinical studies (eg, Actual Use Trials), ensuring compliance with clinical , regulatory, ... **Global Switch Medical Strategy Lead ** + _Location: Morristown, NJ /Hybrid_ **_About the...understanding of technical requirements for switch. Proven experience in clinical and consumer behavior studies for switches… more
- Bristol Myers Squibb (Madison, NJ)
- …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
- Sanofi Group (Morristown, NJ)
- …could be critical in helping our teams accelerate progress. Join our Global Switch group as Global Switch Science Lead (Innovation) where you will be responsible ... **Global Switch Science Lead (Innovation)** + _Location: Morristown, NJ (Hybrid)_ **_About...success in navigating global or regional regulatory environments. + ** Clinical and Consumer Studies ** : Experience conducting… 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
- Sanofi Group (Morristown, NJ)
- **Job title** : Oncology HEVA Business Partner - Alphamedix Launch Lead **Location:** Cambridge, MA or Morristown, NJ **About the Job** Sanofi Specialty Care has ... the lives of patients. The US Health Economics and Value Assessment (HEVA) lead will be accountable for developing Health Economic and Outcomes Research (HEOR) plan… more
- Sanofi Group (Morristown, NJ)
- …ensuring compliance with local regulations. + **Switch Product Expertise** - Experience in clinical and consumer studies relevant to switch programs, with a ... **Global Switch Science Lead (ACNU)** + _Location: Morristown, NJ/Hybrid_ **_About the...our teams accelerate progress. Join our Global Switch Science Lead where you will be responsible for leading the… 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
- Sanofi Group (Morristown, NJ)
- …psychometric analyses; oversee interpretation and discussion of results supporting the clinical study report, regulatory discussions and/or publications. + ... a go-to person in digital biomarkers and provide technical guidance to other project/ study statisticians, stakeholders and junior staff. + Lead the provision of… more
- Sanofi Group (Morristown, NJ)
- …design and execution of phase 3b and phase IV clinical studies . ** Clinical Evaluation and Business Development** + Lead the clinical evaluation of ... integrated medical plans for new drug indications in dermatology and rheumatology. + Lead cross-functional teams in the clinical evaluation of pre- clinical … 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
