- Gilead Sciences, Inc. (Parsippany, NJ)
- …(ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies . + Proven ability and experience to effectively execute ... Operations leader for a Director position within our Oncology Group . Clinical Operations is responsible for the...to support a fluid 'One Ops' workforce. You will lead and/or effectively engage in Clinical Operations,… 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)
- …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 (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
- Merck (Rahway, NJ)
- …the activities of Clinical Scientists in the execution of clinical studies . + Work closely with a cross-functional group of experts in commercialization, ... trials for investigational drugs + Analyzing and summarizing the clinical findings from studies to support decisions...safety and efficacy as well as new drug applications, clinical study reports, or publication; and +… 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
- Sanofi Group (Morristown, NJ)
- …key external stakeholders. + Ability to understand and effectively communicate vaccine clinical studies , both interventional and observational + Knowledge of ... clinical trials (ie, Ph 4 post-marketing and observational studies ) for new products that may join franchise portfolio...and ESC applications + Liaise with the investigators of study applications. + Present studies to the… 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
- Teva Pharmaceuticals (Parsippany, NJ)
- …the preparation/review of related key documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The ... the Clinical Development plan + Works with Clinical Supplies Group to ensure clinical...and direction to the review and finalization of Protocols, Clinical Study Reports and other relevant … more
- Sanofi Group (Morristown, NJ)
- …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
- Bristol Myers Squibb (Summit, NJ)
- …and registrational strategy + **Accountable for the** Clinical Pharmacology Plan + ** Lead ** design of clinical pharmacology studies and manages data ... clinical study design...cross-functional drug development teams, and regulatory submissions; serves as Clinical Pharmacology subject matter expert + ** Lead … 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …Advisory meetings, development of target indications, clinical development plans, study designs and program feasibility. + Lead program specific team ... clinical medicine and drug development processes. He/she will be the clinical lead for large global, multidisciplinary teams, mentoring and motivating… more
- Sanofi Group (Morristown, NJ)
- …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
- Pfizer (New York, NY)
- …medical practice. Our mission is to inspire the medical community to enhance clinical practice and public health, driven by a deep personal purpose to achieve ... join our team. You'll be part of a dynamic group that leverages analytics, and fosters strategic collaborations to...now! **ROLE SUMMARY** The Vice President, US Medical Affairs Lead , Pfizer Internal Medicine (IM) is responsible for leading… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …such as team capability development. **EXAMPLE 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)
- …a cross-functional team. + Ability to understand and effectively communicate vaccine clinical studies , both interventional and observational + Ability to analyze ... of company-sponsored clinical trials (ie, Ph 4 post-marketing and observational studies ) for new products that may join franchise portfolio in accordance with… more
- Merck (Rahway, NJ)
- …of Phase I studies ; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, ... perspective into the earliest stages of target identification and validation, and executing clinical studies to evaluate the relevance of potential targets to… 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