- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with DS standards. The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd Party Vendor Management and Oversight: ... Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …LeadershipHas primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan ... including critical path activities and interdependencies for assigned clinical stud(ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase development in the ... at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will be...with a focus on patient safety and data integrity, site scientific engagement, and HA responsesInteractions with the internal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilitiesSummaryThe Associate Director, Global Oncology Clinical Development (GOCD) Functional Excellence supports the development and ... a library of educational slides to be used for Investigator Meetings, Site Initiation Visits (SIVs) and other educational needs across assetsPartners with IT… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … lead statistician on SAP update, as needed. Provides input to Clinical Operations on site issues. Contributes to development of CSR.External collaboration: ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and supports Supply Chain Management with technical issues post first CPV.Responsibilities- Lead and coordinate the Site -Launch activities and associated teams ... or gaps at the manufacturing sites.- Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. (mAb, Drug Substance,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Insmed Incorporated (Trenton, NJ)
- …mission to transform the lives of patients. They must possess a high clinical aptitude and experience in portfolio selling environment to engage key customers. Along ... role and can be located in or around: Trenton, New JerseyResponsibilities Develop, lead , and execute a sales plan with specific goals and targets to maximize… more
- Insmed Incorporated (Bridgewater, NJ)
- …Director of Biostatistics is a highly visible role within the Clinical Development organization and is responsible for the statistical leadership and ... plan, researches and leads the statistical design, analysis, and reporting of clinical trials, and interacts with global regulatory agencies. This role also leads… more
- Insmed Incorporated (Bridgewater, NJ)
- …at Insmed's CMOs including tech transfer, process optimization, clinical /commercial manufacturing, process characterization and validation, and manufacturing CMC ... for being the Technical Operations liaison to the Insmed research team for lead optimization and early development programs. This position will be the dynamic… more
- Insmed Incorporated (Bridgewater, NJ)
- …responsibilities will include, but not necessarily be limited to, the following: Lead complex clinical trials or indication corresponding to one or ... Director of Biostatistics is responsible for the statistical aspects for complex clinical trial(s) or indication product line. This role leads the protocol… more
- Insmed Incorporated (Bridgewater, NJ)
- …The Director of Field Medical Excellence will establish and lead worldwide Field Medical Excellence Forums.ResponsibilitiesField Medical Strategy - Develop ... Planning, Coaching Framework, Field Impact Assessment, MSL functional onboarding, Clinical Trial Support Framework, etcOperational Excellence - Develop consistent… more
- Insmed Incorporated (Bridgewater, NJ)
- …teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the overall ... the potential impact of toxicology results on Program and Clinical /Regulatory strategy.Author nonclinical sections in regulatory submission documents (eg, IBs,… more
- Virtua Health (Westampton, NJ)
- …Southampton, NJ Job Information: Summary: The Lead Medical Assistant(s) will take a clinical lead at their site , including training and establishing work ... to and recommend operational improvements to Practice Management. The Lead MA may serve as the site ...The Lead MA may serve as the site Safety Rep. Performs various clinical responsibilities… more
- Bristol Myers Squibb (Princeton, NJ)
- …with external research entities and networks of practicing clinicians. The Director, Clinical Research Collaborations Lead , will co- lead cross-functional ... throughout the lifecycle of the studies. Reporting to the Senior Director, Clinical Research Collaborations Team Lead for Immunology, Cardiovascular &… more
- Bristol Myers Squibb (Princeton, NJ)
- …. **Position Summary** The Medical Evidence Generation (MEG) Clinical Research Collaborations (CRC) team actively bridges Bristol Myers ... academic institutions and networks of practicing clinicians. The Director, CRC Lead , Hematology/Cell Therapy, will co- lead cross-functional efforts focused on… more
- IQVIA (Bridgewater, NJ)
- …teams to improve patients' lives by bringing new drugs to the market faster. The Senior Clinical Lead is a member of the core project team responsible for ... out of scope work. * Work as the primary Clinical Lead alongside other Clinical ...as they assimilate into this role. * May attend site visits as applicable in support of project delivery.… more
- Bristol Myers Squibb (Princeton, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . The Director will be the clinical lead to progress early clinical assets from ... will prepare the clinical development plan, design clinical trials and lead the clinical...and medical accountability for multiple trials across early development clinical lifecycle + Manages site interactions in… more
- Bristol Myers Squibb (Princeton, NJ)
- …data review of trial data, including eligibility review + Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) for medical ... Development Expertise & Strategy + In collaboration with the Clinical Development Lead , designs and develops ...with CS to support executional delivery of studies (eg, site activation, enrollment status, as well as adjudication for… more
- Bausch Health (Bridgewater, NJ)
- …supply requirements are met. + Ensure appropriate communication with and maintenance of clinical study sites including training of site personnel in the study ... data clean-up and lock process. + Liaise with study site personnel and clinical investigators to provide...training sessions, and by acting as a resource to clinical staff. May lead training sessions. +… more
