Reilinde Nopper

Experience

• 

  Zentrum für Molekulare Neurobiologie Hamburg (ZMNH)

  Jan 1991 - Jan 1993

  Post Doc

  Post Doctorate: Basic Research and Lecturing - Molecular biology and electrophysiology of potassium channels.- Lecturer on physiology for a postgraduate course in molecular biology.- Set-up of electrophysiology laboratory.

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  Bayer

  Jan 1993 - Jan 2001

  Laboratory Head CNS Research

  Laboratory Head, Coordinator of Pain Research - Head of Electrophysiology Lab with 5 technicians, Chronic Pain Research- Coordinator of Pain Research: - Leading the cross-functional preclinical pain team.- Leading the collaboration with Key Opinion Leaders and Experts.- Participation in due diligence activities

• 

  Institute of Medical Outcome Research

  Jan 2002 - Apr 2004

  Head of Clinical Operations

  Responsibility for the Clinical Operations Department with up to 10 Clinical Research Associates in terms of:- Clinical Trials: Planning, design and conduct of national and international clinical studies phase II – IV, post marketing surveillances, registries, with drugs and devices, in compliance with regulatory requirements.- Protocol writing, project management and monitoring.- Quality assurance and control.- Representation of Clinical Operations in acquisition activities: preparation of proposals incl. budget calculation, participation in bid defense meetings, contract negotiations and contract execution.- Line Management and coaching of project managers/team members. Weniger anzeigen

• 

  BIOMIT

  Jan 2004 - Jan 2004

  Head of Project Management
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  Actelion (now Janssen Pulmonary Hypertension)

  Jan 2004 - Nov 2015

  - Line management and strategic leadership to (Senior) Global Trial Managers globally on multiple projects, hiring, on-boarding, and training/coaching of new staff - Initiation, development and implementation of global processes and process improvements.- Development and monitoring of Key Performance Indicators for Project Management activities.- Resource planning and management, assuring adequate resources are assigned to clinical trials.- Ensuring operational excellence, compliance, and integrity through adherence with Actelion’s policies, SOPs, ICH-GCP, and FDA and international regulatory requirements Weniger anzeigen - Operational planning of global phase II and III clinical trials for several programs in various therapeutic areas including budget forecasting, resource planning, assessment of feasibility and planning of timelines. Providing operational input to clinical development plans, definition of high level study plans and key milestones together with cross-functional team members- Initiation of all study activities such as initiation of outsourcing activities, forecasting and ordering of IMP, kick-off of core team together with Clinical Project Leader, country- and site selection activities, review of study documents from operational perspective.- Provision of high level product support to ensure global standards are adhered to. - Assurance of process consistency across multiple clinical trials. - Line management of up to 30 direct reports in Global Clinical Operations in the Allschwil office Weniger anzeigen

  • Director, Gobal Clinical Operations Group Leader

    Jun 2011 - Nov 2015

  • Operations Product Leader

    Jan 2007 - Jun 2011

  • Operations Manager

    Jan 2004 - Apr 2007
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  Roche

  Nov 2015 - now

  - Provide leadership, management, coaching and functional expertise to Global Study Leaders, Managers and Associates to ensure individuals are able to contribute to the delivery of global clinical studies and functional projects.- Ensure effective resource management for team and department in Global Operations Oncology.- Provide functional expertise to initiatives and activities across the organization

  • Global Project Manager

    Apr 2018 - now

  • Functional Manager

    Nov 2015 - now