- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or project; Attends EOP2 meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase 3 registrational ... biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team ...Present results to regulatory agencies during pre-submission meetings; Interpret study results in context of other studies … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …resolve, propose solutions, or bring to the attention of the operations lead of study team lead . Coordinate and liaise with Daiichi Sankyo QA on site ... quality deliverables. Lead the development of the clinical study plan including critical path activities...CRO and vendor selection process in collaboration with the study team and outsourcing procurement management. Lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …studies from end to end in collaboration with GCLs, Physician Scientists and the study team (data management, clinical operation and other functions) to ... site scientific engagement, and HA responsesInteractions with the internal clinical study physicians and physician scientists as...Global Clinical Science Strategy and delivery of clinical studies in late stage developmentLead and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …resolve, propose solutions, or bring to the attention of the operations lead of study team lead . Coordinate and liaise with Daiichi Sankyo QA on site ... and quality deliverables. Lead the development of the clinical study plan including critical path activities...CRO and vendor selection process in collaboration with the study team and outsourcing procurement management. Lead… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head...Quality Assurance (QA) and acting as the link between Clinical Development, study teams, global business functions… more
- Insmed Incorporated (Bridgewater, NJ)
- … studies and provide clinical pharmacology support to late phase clinical studies Plan, perform, and/or oversee PK, PK/PD and pharmacometric analyses for ... to support clinical dose and dosing regimen selection, facilitate clinical study design and support regulatory submissionsAuthor regulatory summary… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … clinical activities as appropriate.Responsibilities Clinical Operations Study / Program ManagementCompany Sponsored Studies (CSS) Support the preparation, ... clinical operations systems for management of company sponsored studies review and approvals are current and accurate.Liaison and...key activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data, and… more
- Merck & Co. (North Wales, PA)
- …development and execution; clear strategic view on the Translational needs in clinical studies ; Experience & familiarity with experimental and bioinformatic ... cancer across the globe. Working with the Asset Development Team (ADT's), early- & late-stage clinical development...a minimum of 8 years' experience in oncology biomarker studies and translational clinical research, or comparable… more
- Merck & Co. (Rahway, NJ)
- …support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint ... and supervise the activities of Clinical Scientists in the execution of clinical studies . Work closely with a cross-functional group of experts in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …represent the CSPV on the Global Product Team or specific sub-teams such as clinical study team and submission team , providing the safety leadership ... Clinical Safety, will be a product safety lead or part of a product safety team...and provide safety leadership including but not limited to clinical studies , post-marketing surveillance, signal detection and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team ... the CSL and Medical Monitor in the execution of Clinical Development functions. Responsibilities Study Strategy: Drafts...and ARO Scope of Work and budget; participates in study team meetings with CRO and ARO;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies , conduct hands on population PK and PKPD analyses and ... all aspects of clinical pharmacology and biopharmaceutics studies ; clinical pharmacology project lead ;...interactions at project level, interacts with regional and global study and project team members, and to… more
- Eisai, Inc (Nutley, NJ)
- …GV&A projects related to both clinical trial setting and observational studies .Serve as the lead statistician on project teams, offer statistical insights ... crucial role within the Global Value & Access (GV&A) team , responsible for leading and overseeing statistical activities across... clinical trial data, patient registries, and observational studies ) to support study design and otcomes… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related to the ... outsourcing of clinical services to Clinical Research Organizations (CROs)...lead recruitment initiatives as required.Accountable for regional outsourcing team deliverables and compliance with global and regional processes.Ensure… more
- Eisai, Inc (Nutley, NJ)
- …to evaluate biomarkers across programs, as well as the study statistician for clinical studies . As the statistical lead for biomarker development, this ... managing CROs. The immediate need is to manage early clinical development studies primarily in support of...conduct to proactively address issues to ensure high quality study data (as needed). Clinical Study … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with… more
- Merck & Co. (North Wales, PA)
- Job Description- Role Summary:The Process and Systems Lead Senior Director, Medical Operations ( Lead , P&S) is a leadership role within Global Medical and Value ... (GMSA) that reports directly to the Executive Director (ED) Global Medical Operations Lead .-The Lead , P&S is responsible for managing people and building optimal… 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 ... Clinical Scientists (CS)- Interpretation and presentation of clinical study (ies) data to internal and external...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Aequor (NJ)
- …associated studies , lead communications regarding global supply strategy with Study Team or Country Affiliate Medical Affairs team as appropriate. ... clinical supply strategy in support of global clinical studies , as well as monitoring and...IRT) requirements. Actively participating in Trial Supplies Management Functional team , Study Team , Country Medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relevant regulatory requirements. This position has experience working on Phase I-IV study studies within the medical device and/or pharmaceutical industry ... Policies, SOPs, and other relevant guidelines.Ensures Data Management deliverables meet/exceed project/ study team expectations regarding quality, time, and cost… more
