(Associate) Director* Clinical Operations Process Improvement
- BioNTech Careers
- Cambridge, Massachusetts
- Project Management, Product Management
- Published: 26.07.2022
Become a member of the BioNTech Family!
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.
Director* Clinical Operations Process Improvement
Your main responsibilities are:
- Plan, develop, execute and track process improvement and operational initiatives related to clinical trials and ensure integration with systems, risk-based management approach.
- Evaluate quality measure analysis including performance development and reporting, working towards increased modernization and digitalization, and provide recommendations to the CDO leadership team.
- Maintain a proactive GCP compliance management infrastructure/process, system within GCO, including clinical trial oversight processes, monitoring and quality control of key processes (eTMF), standard operating procedures, process improvement, and training recommendations.
- Identify required resources needed to support process optimization and implementation efforts including personnel, tools, and facilities across functions; work with Sr. Director, Process Excellence to develop a data analytics driven operational strategy & an operational metrics framework to measure trial delivery effectiveness.
- Ensure adherence to regulatory requirements (ICH, FDA, EMA, etc.) and GCP guidelines through the establishment and reporting of clinical performance indicators KPIs/KQIs as well as through the use of innovative and agile methodology to improve processes.
What you have to offer.
- Bachelor’s degree in a business, science, or healthcare related field or equivalent. Master’s degree highly preferred.
- Many 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
- Successful and demonstrable track record delivering end-to-end (from conception to benefits realization) process improvement initiatives
- Experience working with external parties and/ or leading cross-functional teams
Benefits for you.
- Company Pension Scheme
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation
Have we kindled your pioneering spirit?
If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).
Job-ID 6689 (please indicate for inquiries)
We look forward to your application!
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!
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