- 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 Clinical Study Lead ** (CSL)...studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug ... in this role looks like:** + Leads the cross-functional study team responsible for clinical study...implements the operational strategic direction and guidance for respective clinical studies + Demonstrates expert knowledge and… 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
- 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
- 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 (Princeton, NJ)
- … research, or equivalent + Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations + Proficient knowledge ... Science function which provides scientific expertise necessary to design and deliver clinical studies and programs. **Position Summary / Objective** +… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …**Pharmacokinetics-Pharmacodynamics (PK/PD)** and regulatory submissions. You will lead study design, execution and reporting of ** clinical pharmacology** ... development and regulatory packages **.** + Lead ** clinical pharmacology** activities related to study design,...NLME, etc. + Excellent working knowledge of phase I study design, clinical trial operations ,… 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
- Actalent (Princeton, NJ)
- …to and collaborate with the senior Clinical Trial Manager and VP of Clinical Operations . + Lead and participate in activities ensuring quality, ... Job Title: Clinical Trial ManagerJob Description The Clinical Trial Manager acts as a vital operations leader within the global study team, ensuring… more
- Taiho Oncology (Princeton, NJ)
- …investigator brochure (IB), informed consent forms (ICF), case report forms (CRF), Clinical study report (CSR), NDA/MAA registration documents, and scientific ... publications. + Analyze and interpret outcome of clinical studies within the global development program(s) + Answer medical questions raised by Regulatory… 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
- Sanofi Group (Morristown, NJ)
- …and communication plans with Commercial and Investor Relations. + Direct management clinical lead . + Matrix leadership and dotted-line management toward all ... GPT members, including eg project management, clinical operations , regulatory, safety, translational medicine, statistics, CMC, IA **Basic Qualifications:** +… more
- J&J Family of Companies (Raritan, NJ)
- …health, patient recruitment, study management/oversight and digital collaboration across clinical trials. + Lead /manage a high-functioning and diverse team ... beneficial, meet regulatory compliance standards and are tailored to the needs of clinical study teams. + Prepare and manage financial plans, ensuring… more
- RWJBarnabas Health (New Brunswick, NJ)
- …NJ 08901 The Clinical Pharmacist Specialist position functions as a higher level, clinical lead Pharmacist to carry out a wide range of duties for patient ... monitoring to identify, prevent, or mitigate medication-related problems, - Functions as a clinical lead position in the department providing support to Staff… more
- Pfizer (New York, NY)
- …guidance from a more senior study clinician. Depending on experience, you may lead the development of the clinical protocol and may participate as an ... . You will work with other functional disciplines (eg, Clinical Operations , Biostatistics/Data Management, Clinical ...Early Stage Development (OESD) is represented as needed within clinical study teams. You will also be… more
- Bristol Myers Squibb (Summit, NJ)
- …protocols and protocol requirements and educate team members. + Plan and lead the implementation of clinical study startup/conduct/close-out activities ... research, or equivalent. + Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations . + Proficient knowledge… more