- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical function at meetings with health authorities; Oversees management and performance of CRO . Occasional interactions with CRO senior leadership as ... and high level execution plan, communicate to members of study team within sponsor, CRO and vendors;...Present results to regulatory agencies during pre-submission meetings; Interpret study results in context of other studies … more
- Merck & Co. (Rahway, NJ)
- …projects.-Interacts with Academic Research Organization (ARO), Contract Research Organization ( CRO ) and external statistical consultants.This position may serve as a ... strategies.Ensures the statistical designs and analysis methods utilized in clinical studies are scientifically sound and meet worldwide regulatory and marketing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …uncomplicated clinical studies ; Coordinate sponsor medical monitors across regions; Direct CRO medical monitor activities for a large study and/or across a ... clinical function at meetings with health authorities; Oversees management and performance of CRO . Occasional interactions with CRO senior leadership as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …appropriate Governance Committee. Analyze CRO performance trends within a clinical study or across several studies and resolve or escalate accordingly.People ... studies , and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning...StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manner and with quality (eg communication plan, site monitoring plan, etc.) as per study plan.Responsible for overseeing CRO study start-up activities and ... analysis, database lock and review of TLG before and after database lock.Oversee CRO study close-out activities (including but not limited to TMF reconciliation)… more
- Merck & Co. (Rahway, NJ)
- …well as oversight of Local Clinical Evaluations (LCEs) of an interventional nature and CRO run studies . Will adhere to Good Clinical Practices (GCP), local and ... for the company's internal clinical trial portfolio.Partner with Clinical Research Organization ( CRO ) Senior , Regional and local team to ensure the successful… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Establishes effective communication between CRO / vendors / AROAdditional non- study related activities: Occasional senior management interactions at FIHC, ... Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with Translational Medicine/Clin… more
- Amgen (Los Angeles, CA)
- …10 million patients worldwide. It's time for a career you can be proud of. Senior Director , Clinical Program Operations, Obesity - US, Remote **Live** **What you ... + Initiate and support conduct of Country Operational Landscape Assessments and study feasibility with Development Feasibility Senior Managers + Contribute… more
- Charles River Laboratories (Mattawan, MI)
- Senior Director , Laboratory Sciences Req ID #: 222574 Location: Mattawan, MI, US, 49071 For 75 years, Charles River employees have worked together to assist in ... in the conduct, direction and execution of Laboratory Sciences operations and studies . Provide scientific and strategic direction, oversight, and guidance to staff… more
- J&J Family of Companies (Spring House, PA)
- Senior Director and Discovery Head, Interventional Oncology - 2406184858W **Description** At Johnson & Johnson, we believe health is everything. Our strength in ... by improving survival and finding cures. INTO is recruiting for an Immuno-oncologist Senior Director within the Discovery and Translational sciences team. The… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …is true to the best of my knowledge. **Job Description** **Job Description for Senior Medical Director , Clinical Science, Marketed Products Development** As the ... Senior Medical Director Marketed Products (SMDMP) you will report to the...studies , protecting the safety of patients within the study . Responsible for internal oversight of strategic partner vendor… more
- BeiGene (San Mateo, CA)
- General Description: The Senior Medical Director , Hematology will support BeiGene Clinical and Medical Hematology assets by successful execution of clinical ... areas for the successful implementation and execution of clinical studies + Provide scientific expertise for selection of investigator...selection of investigator and vendors + Train BeiGene colleagues, CRO staff, and study site staff on… more
- HistoWiz (Long Island City, NY)
- …into GLP to support our customers' growing histology needs. Who are you? The Senior Manager/ Director of Quality is responsible for overseeing the quality and ... etc. + Lead internal audits in support of GLP studies , writing inspection reports, following up on observations, ensure...on any findings. + Prepare QA statements for GLP study reports. + Prepare laboratory and staff for GCLP… more
- Sanofi Group (Cambridge, MA)
- The Senior Clinical Research Director (Sr CRD) is noted as the primary clinical lead for dermatology programs. The role requires a well-organized, strategic ... deliver to multiple operational tasks. The role of the Senior CRD is to: + Act as a mentor...studies ) and/or registries (eg: protocol, Key Results, Clinical Study Report) + Support other clinical development activities (eg… more
- BeiGene (Emeryville, CA)
- …the region and provides regular updates on portfolio progress in the region to senior management and Global Clinical Study Manager as required. + Champions ... provides inspirational leadership, proactive management, and feedback-oriented mentorship to clinical study managers at various levels for assigned portfolio and may… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …clinical function at meetings with health authorities; Oversees management and performance of CRO . Occasional interactions with CRO senior leadership as ... define study priorities and high level execution plan, communicate to members of study team within sponsor, CRO and vendors; Ensure clear and effective lines… more
- GRAIL (Menlo Park, CA)
- …company is using the power of next-generation sequencing, population-scale clinical studies , and state-of-the-art computer science and data science to enhance the ... Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com . The Sr. Director , Medical Safety will lead the development and implementation of a robust… more
- Merck (Rahway, NJ)
- …+ Interacts with Academic Research Organization (ARO), Contract Research Organization ( CRO ) and external statistical consultants. + This position may serve as ... + Ensures the statistical designs and analysis methods utilized in clinical studies are scientifically sound and meet worldwide regulatory and marketing needs. +… more
- Boehringer Ingelheim (Ridgefield, CT)
- …one or more products or disease areas. Design, execute and report on RWE studies in support of assigned products and indications. Provide RWE methods advice to ... other functions/regions within BI. Communicate effectively about US RWE strategy and study results with various internal and external stakeholders. As an employee of… more
- ThermoFisher Scientific (Greenville, NC)
- …(comparable to 2 years). _Additional experience required for Sr Med Director level. Experience should be industry specific( CRO /Pharma). Management/Leadership ... + Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining… more