- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Clinical Research Director (CRD) is the Clinical Operations lead in a country/cluster and is responsible-for execution of all Clinical ... trials. Engagement With Key External Stakeholders -Supporting Management and the clinical operations of studies managed by GCTO.-Support the development and… more
- 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 publications.Participation in internal...entire Clinical Teams in the execution of clinical studies .--Will report and work collaboratively with… more
- Merck & Co. (Rahway, NJ)
- …of Clinical Scientists in the execution of clinical studies .Work closely with a cross-functional group of experts in commercialization, regulatory ... support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint… more
- Merck & Co. (Rahway, NJ)
- …interfacing with scientists who are manufacturing drug substance to support early clinical studies , scaling up new chemistries, and exploring new technologies. ... Specialist - Prep Lab Engineer Job Description: The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is… 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 (Rahway, NJ)
- **Job Description** The Clinical Research Director (CRD) is the Clinical Operations lead in a country/cluster and is responsible for execution of all ... With Key External Stakeholders** + Supporting Management and the clinical operations of studies managed by GCTO....matrix organization with all groups within GCTO, especially with Clinical Sciences and Study Management (CSSM), … more
- 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
- 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
- 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
- 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
- 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
- IQVIA (Parsippany, NJ)
- …is a must-have, as well as developed analytic skills. Key collaborators are the Clinical Lead for site management, the Project Vendor Manager, the Project ... This is a remote/home based position. We are looking for Senior Project Leaders/ Clinical Program Managers to join our innovative and dynamic group of global… 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
- 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
- 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …Operations to ensure e-CTD compliance. + As required, serves as a global regulatory lead on a specific or assigned clinical program. **Qualifications** + Minimum ... (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions.… more
- AbbVie (Florham Park, NJ)
- …Statistical Programming and other stakeholders to evaluate existing databases, both clinical studies and real-world databases, conduct feasibility assessment to ... + Provide expertise to design, analysis and reporting of clinical trials or other scientific research studies ....pre-planned safety analyses and ad hoc requests. + (SSG) Collaborate/ lead within the Safety Statistics Group to… more
