- Bristol Myers Squibb (Princeton, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Functional Area Description** The Clinical Development Lead sits within Clinical Development, ... Objective** + 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 (Princeton, 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 (Princeton, 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
- J&J Family of Companies (Titusville, NJ)
- …eg clinical development plans, protocol development, execution of clinical studies , preparation of clinical study reports and for the preparation ... regulatory affairs, data management, medical writing, biostatistics, global medical affairs, clinical pharmacology, clinical operations , health economics,… 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
- J&J Family of Companies (Spring House, PA)
- …early development studies . In close collaboration with the Rheumatology Program Clinical Lead , the Director will drive design of, conduct, and provide ... Rheumatology, leads a group of Clinical Scientists (CS) responsible for designing clinical studies outlined in the early development plan (EDP) for assets… more
- Otsuka America Pharmaceutical Inc. (Trenton, 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
- Bristol Myers Squibb (Princeton, 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
- Bausch + Lomb (Trenton, NJ)
- …future. **Position Summary** **:** Is responsible for the implementation and oversight of clinical study operations by organizing and coordinating with other ... sites including training of site personnel in the study protocol and other study -specific procedures. + Supervise clinical operations team to ensure all … 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
- Sumitomo Pharma (Trenton, NJ)
- … clinical studies . **Job Duties and Responsibilities** + Contribute to and/or lead the design of clinical studies in close collaboration with the ... Clinical Study Reports and other clinical documents. + Complete and/or lead other...working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies . + Experience with interacting with… 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
- 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 (Princeton, 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
- Sumitomo Pharma (Trenton, NJ)
- …and regulatory requirements. + Lead the medical and scientific aspects of clinical trials, including protocol design, study endpoints, and data analysis. + ... of the clinical programs, and liaises with Clinical (including Clinical Operations ), Biometrics,...ensuring that the design, implementation, and conduct of the clinical studies provide unambiguous data and information… more