- 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
- 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. (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
- 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
- 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
- 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
