- Sanofi Group (Morristown, NJ)
- …its endorsement by governance and its execution in close collaboration with clinical operations . The clinical lead is expected to advance scientific and ... **Job Title:** Clinical Lead , Brivekimig **Location** : Cambridge,...studies and to create an abbreviated and full clinical study protocol + Oversee the execution… more
- Organon & Co. (Jersey City, NJ)
- …execution (in collaboration with the TMED operations lead and study biostatistician), analysis and interpretation of TMED studies in accordance with the ... to 2a study protocols, in collaboration with internal (biostatistics, clinical operations ) and external (contract research organization [CRO], bioanalytical… more
- Bristol Myers Squibb (Madison, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Clinical Development Lead sits within Clinical Development, ... trials. + CDLs are matrix leaders and managers who lead , develop, motivate and achieve results through teams; demonstrate...studies , with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication +… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The **Senior Manager Clinical Study Lead ** (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of ... studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug...study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and… more
- Bristol Myers Squibb (Madison, NJ)
- …members of the matrix team ( Clinical Development, Regulatory, Translational Medicine, Clinical Pharmacology, Safety, Clinical Operations , Clinical ... in their personal lives. Read more: careers.bms.com/working-with-us . The Director, External Clinical Collaborations Lead is responsible for driving clinical … more
- Bristol Myers Squibb (Madison, NJ)
- …teams **Key Competency Requirements** + Expertise in GCP/ICH, drug development process, study design, statistics, clinical operations + Recognized internally ... Science function which provides scientific expertise necessary to design and deliver clinical studies and programs. **Position Summary / Objective** + Partners… more
- Meta (New York, NY)
- …clinical study manager to support clinical research operations . The Clinical Study Operation Lead will work closely with other clinical ... inequity in health outcomes throughout the world. **Required Skills:** Clinical Study Operation Lead...projects, regulatory studies , and a variety of clinical study designs and modes of … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …coordination, authoring, and management of Dose Preparation Instructions in support of clinical studies being conducted globally by Daiichi Sankyo. The candidate ... will collaborate globally with Formulation and Analytical Scientists, Clinical Operations , Regulatory Affairs CMC, and Clinical Development to collate the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …updates Study Supply Plans in close communication with CSO project Management Lead . + Responsible for the Clinical Label Development process which includes ... position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is...supporting CSO Project Management Leads by developing and updating Study Supply Plans, managing various work streams with key… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …as the scientific/medical lead for supervising the design of high-quality clinical study protocols, and drive the delivery of informative and actionable ... targets. + Together with the TFA heads and RGC, lead the design of studies that will...study results, and ensure the creation of high-quality clinical study reports and memos and make… more
- Pfizer (Pearl River, NY)
- …including post licensure regulatory commitments. This role will serve as a clinical lead for one or more studies , within a clinical program, and ... a matrix team in executing studies and medical monitoring and take a lead in study teams for many of the clinical deliverables. **ROLE… more
- Sanofi Group (Morristown, NJ)
- …teams accelerate progress. The Senior Clinical Research Director (CRD) is an **expert clinical lead for one or several indications in the Development of an ... to the cross functional project team to conduct the clinical studies from early phases to LCM... from early phases to LCM programs + Establish clinical development strategy and lead clinical… more
- Sanofi Group (Morristown, NJ)
- …to the clinical studies and/or registries (eg: protocol, Key Results, Clinical Study Report) + Support other clinical development activities (eg ... Information, study specific committee charter, etc) + Clinical support to clinical operation ...deviation review, etc) + Clinical support to clinical operations team on study … more
- Bristol Myers Squibb (Madison, NJ)
- … research, or equivalent + Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations + Proficient knowledge ... of assigned clinical trial activities. Serves as Clinical Trial Lead for one or more...committee (eg, DMC) activities + Drafting/review and validation of clinical study reports (CSRs) and clinical… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …members of Global Supply Chain (GSC) and other Gilead functions - eg, Clinical Development, Clinical Operations , Product Development & Manufacturing (PDM), ... + Often in a matrix environment, oversees and supports clinical study planners. Facilitates issue and risk...sourcing and managing comparator drugs and other co-meds for clinical studies , and, in comparator sourcing strategy.… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Ensures safety of the drug, including the safety aspects of patients in clinical studies and signal detection from post-marketing surveillance, with the support ... programs and serves as an expert resource to anticipate/resolve study /asset clinical and conduct issues. For assigned...For assigned programs, the incumbent will serve as the Clinical Program Lead (CPL) for one or… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- … for clinical trials in the CDP and is responsible for the design of clinical study concepts leading to clinical trial protocols. This role requires a ... the relevance and accuracy of medical science underpinning of clinical study concepts (CSC) based on thorough...unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- … trials' experience, preferably in Oncology development. The Medical Director drafts designs of clinical study concepts which lead to clinical trial ... + Collaborates with Clinical Project Managers and Clinical Trial Managers at the study level...unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …looking for a Clinical Data Manager who will serve as the DM study lead and point of contact for clinical study teams and external partners, (eg, ... all applicable policies and procedures. **_As a Data Management Study Lead , a typical day may include:_**...high level of expertise in data management to support clinical studies . + Provide clear verbal or… more
- System One (Tarrytown, NY)
- …potential to convert Start Date: ASAP Individual will work with Precision Medicine Strategy Lead as well as clinical study teams, data management (DM) ... central/specialty lab with support from SKDL * Supports individual clinical study teams as required for all...of samples and data, as well as reporting/billing for study related operations * Liaises with Precision… more