- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Support commercial in developing a strategy including patient selection strategy .- Construct and co- lead Advisory Panels at certain scientific conferences. ... disorders. Summary: The position will define and oversee the translational medicine strategy for a drug program across multiple indications. The successful candidate… more
- Merck & Co. (Upper Gwynedd, PA)
- …Associate Director within Metrics, Analytics & Performance (MAP) has experience in clinical operations and is responsible for leading the development of analysis, ... modeling, and visualizations in support of user needs across Global Clinical Trial Operations (GCTO).Primary responsibilities include but are not limited to:Leading… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …initiatives. The incumbent will oversee the development and promotion of the 6th Mid-Term Strategy for Global QA, lead the execution of the business plan, and ... around rare diseases and immune disorders. Job Summary: Director, Global QA Strategy &Operations (Global R&D PV QA) is responsible for providing strategic leadership… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction of the Senior Director, USMA Oncology (US Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical ... or indication. The role is primarily responsible for US Medical Affairs Strategy and overseeing execution of medical activities for assigned indication(s) and… more
- Formation Bio (New York, NY)
- …pharma company of the future.ResponsibilitiesAs a member of the Business Operations & Strategy team, you will lead both ongoing company processes and ad-hoc ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...initiatives that drive the company vision and strategy forward.Operational Excellence Lead bi-annual planning and… more
- Eisai, Inc (Nutley, NJ)
- …position is responsible for design, delivery and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection management, ... Essential Functions Direct and drive design, delivery, and execution of the global Clinical Quality Assurance (CQA) strategy for the country/region in scope… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational quality ... quality management and inspection management activities.The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …organization to implement ongoing learnings from regulatory inspections.Engage and motivate Clinical Operations employees to execute the strategy through ... of the Study Management Group Heads and/or Vice President, Clinical Development Operations.Contribute to and/or lead in...Vice President, Clinical Development Operations.Contribute to and/or lead in the development and growth of the Study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with minimal direction from group head and provide statistical scientific leadership for clinical trial safety data. Lead the statistical support for safety ... disorders. Job Summary: Provide leadership and guidance as the lead statistician dedicated to safety on one or more...and characterization for ongoing studies and compound level pooled clinical trial data of project(s). Act as statistical expert… more
- Merck & Co. (North Wales, PA)
- …Head, Global Clinical Development, Pediatrics will focus on driving strategy , development, and life-cycle management activities for pediatric vaccines in the ... Therapeutic Area. The incumbent will be expected to lead multiple programs that are in various stages of...of development therefore requiring someone who has late vaccine clinical development and lifecycle management experience.The AVP will also… more
- Insmed Incorporated (San Diego, CA)
- …leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on ... and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Summary:The primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) ... drug registration or for any project with CDPs containing multiple registrational clinical trials and are extensively exploring the predictive nature of potential… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …issues throughout the clinical trial process. Customer Focus / Stakeholder:Engagement Lead the implementation of the quality strategy in alignment with the ... mindset with Medical Affairs.Support the Sr. Director's Medical Affairs Quality strategy by partnering with members and business stakeholders for both Oncology… more
- Merck & Co. (Boston, MA)
- …operations teams as they key liaison to enable implementation of precision medicine strategy in clinical trialsContribute to creation of translational plans for ... and Diagnostics, in this role, you will serve as the translational lead on late-stage immunology programs, driving the Precision Medicine objectives in alignment… more
- Insmed Incorporated (San Diego, CA)
- …Affairs, lead the development and implementation of global regulatory strategy plans to facilitate efficient and driven product developmentMonitor the evolving ... within gene therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams (CMC, clinical and project teams)Ability… more
- Formation Bio (New York, NY)
- …proof-of-concept models into scalable, production-ready systems Define technical execution strategy for clinical outcome prediction, indication expansion, and ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...Data Science - Platform at Formation Bio, you will lead one of two critical arms of our Data… more
- Merck & Co. (North Wales, PA)
- …postgraduate training in a related subspecialtySignificant research experience as lead clinical investigator, specifically experience with investigator-initiated ... (EDSA) maximizes meaningful bi-directional scientific exchange with the worldwide clinical and academic community to positively impact Research and Development… more
- Merck & Co. (Boston, MA)
- …(AVP) / Companion Diagnostics will be responsible for leading the diagnostics strategy , bridging the continuum from Discovery Research through Late-Stage Clinical ... scientific direction of companion diagnostics (CDx). - Specifically, the Diagnostics Lead will develop and execute diagnostic strategies and interact with various… more
- Merck & Co. (Rahway, NJ)
- …for the creation and execution of the overall therapeutic aligned US strategy and Country-Medical Affairs Plans (CMAP).The USMA ED is also responsible for ... of their time leading and managing the US RMSD Field Medical strategy and execution.Primary Responsibilities:Leadership and ManagementServes as a senior leader in… more
