Associate Director Process Improvement GCDO

Open for hire at one of the following locations –  Cambridge Erie Street. - Job ID: 7526 

 

Join our team of pioneers!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

 

Associate Director Process Improvement GCDO 

 

As Associate Director Process Improvement GCDO, you will support the planning, development, and tracking of process improvement and operational initiatives related to clinical trials. You will also use a risk-based management approach to ensure integration with other functions and systems across the Global Development organization. You will disseminate a culture of continuous learning across the organization and serve as a cross-functional ambassador for continuous learning as well as for other Global Clinical Development Operations (GCDO) initiatives. You will support process development and improvement across the organization, ensuring that BioNTech brings the highest quality processes and tools. You will support and drive the identification of process gaps, propose potential solutions, and implement these in a harmonized way to help realize BioNTech’s long-term strategy and goals.

 

Responsibilities:

 

• Support Director, GCDO Process Excellence in cross-functional efforts to build the infrastructure necessary to identify, evaluate and execute functional growth opportunities
• Plan, develop and track process improvement and operational initiatives related to clinical trials and ensure integration with systems, risk-based management approach
• Partner across functions to build and maintain a continuous improvement culture, drive fit-for-purpose clinical process development and improvement, support procedural change management, and conduct various quality checks
• Identify process improvement opportunities and partner with key stakeholders to scope and ensure alignment with strategic priorities
• Review results/data from internal as well as external sources to identify implications to clinical operations and make recommendations for process improvements accordingly
• Collaborate with stakeholders on identified process improvement reporting and scheduling
• Support to establish and optimize internal functional relationships/dependencies to increase internal executional efficiency. Share best practices and learnings across the organization to facilitate harmonization
• Support Director, Process Excellence in working towards increased modernization and digitalization
• Support onboarding, conduct training, and support inspection-readiness activities
• Collaborate with QA and GCO to identify root causes for identified issues and devise potential solutions for Corrective Action Plans

 

Requirements:

 

• Bachelor’s degree in a business, science, or healthcare-related field or equivalent. Master’s degree highly preferred
• At least 8 years of experience in the pharmaceutical/biotech/CRO industry in a relevant field, such as Clinical Operations, Clinical Compliance, Clinical Monitoring, Clinical Trial Management, and/or Clinical Quality Assurance
• Advanced understanding of the drug development process with solid experience in clinical operations as a must-meet criteria
• Experience with Six Sigma, LEAN and Agile methodologies
• Demonstrated experience with project management and application of operational excellence concepts
• Ability to think strategically and to translate strategy into actions
• Experience working with ext