Clinical Development Operations Excellence Officer

Clinical OperationsLausanne, Vaud, SwitzerlandFull time

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Description

Debiopharm Group™ (Debiopharm) is a Swiss-based biopharmaceutical group of four companies active in drug development, GMP manufacturing of proprietary drugs, diagnostics, and investments. Debiopharm International SA searches, evaluates and in-licenses promising drug candidates for development. Towards the end of the development process, the products are licensed out to pharmaceutical companies for world-wide marketing and sales. For our Clinical Development organization based at our Headquarter in Lausanne, we are looking for a

Clinical Development Operations Excellence Officer

The Clinical Development Operations Excellence Officer drives Operations Excellence within Research & Development by ensuring compliance to procedures and regulations, identifying opportunities for improvement striving for high quality, enabling individuals and teams to implement continuous improvement solutions, with a focus on processes and tools.

Your responsibilities

Your responsibilities include, but are not limited to:

• Develop strategies and lead continuous improvement initiatives within Clinical Development, identifying and implementing innovative ways and processes for enhancing compliance and quality
  


• In collaboration with Quality Management, to support Clinical Development functions to establish goals and measurable targets for quality and compliance


• Develop mechanisms for reporting on quality and compliance metrics, and foster actions and measures for continuous quality improvements. Elaborate continuous improvement plans and related metrics and KPIs to track progress and ensure follow-through on improvement plans


• Report on strategies, initiatives, and plan progress, tracking related metrics and KPIs, in collaboration with Quality


• Lead, coach, and participate in activities promoting compliance, quality, and operations excellence. Share and adapt “best practices”


• Prepare, execute, and facilitate continuous improvement events such as workshops


• Support the organization to maintain a continuous improvement culture


• Demonstrate expertise in Continuous Improvement strategies and utilize robust change management methodologies to engage stakeholders in the implementation of improvement initiatives


• Develop, deploy, and manage communication and change management plans


• Serve as an internal resource for innovative thinking relating to new trends and activities to support compliance and quality

Requirements

• Bachelor’s or Master’s degree and scientific or medical knowledge or expertise


• At least 5 years’ experience in Pharmaceutical, biotech, or CRO environment, in a Clinical Development role


• Minimum 2 years of experience in a role within clinical trial management with a strong understanding of clinical studies conduct processes


• Minimum 3 years of experience in Continuous Improvement with a proven track record of deploying a range of tools/approaches to enhance operational performance, compliance and quality within pharmaceutical drug development


• Effective change management capabilities


• Comprehensive understanding of the clinical development of pharmaceutical products


• Experience of successful influencing cross functionally and driving cultural change of the organization


• Strong leadership to empower teams on critical thinking, challenge status quo and implement improvements


• Excellent interpersonal skills with ability to lead, engage and negotiate


• Strong organizational, planning, and business skills


• Strong knowledge in International Conference on Harmonization (ICH), as well as Good Clinical Practice (GCP) guidelines and other relevant clinical trial regulations


• Demonstrate high ethical and professional standards


• Fluency and excellent communication skills in English, any other languages are a plus

Benefits

• An international and highly dynamic environment.


• The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.


• The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.

For more information : www.debiopharm.com

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