Mainz, Germany; Cambridge, US; Gaithersburg, US | full time | Job ID: 9611

As Associate Director Process Improvement, you will support the planning, development, and tracking of process improvement and operational initiatives related to clinical trials. This role focuses on fostering a culture of continuous improvement, identifying process gaps, and implementing harmonized solutions that support long-term organizational goals.

Your Main Responsibilites Are:

Support cross-functional efforts to build out infrastructure necessary to identify, evaluate and execute on 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 Review results/data from internal as well as external sources to identify implications to clinical operations and make recommendations for process improvements Support to establish and optimize internal functional relationships/dependencies to increase internal executional efficiency. Share best practice and learnings across the organization to facilitate harmonization. Support onboarding, training, and inspection-readiness activities Work with Quality Assurance and Global Clinical Operations to analyze root causes for identified issues and devise potential solutions for Corrective Action Plans What You Have To Offer: Bachelor's/Master's degree in business, science, or healthcare Minimum 8 years of experience in pharma/biotech/CRO, especially in Clinical Operations or related fields Strong understanding of drug development with solid experience in clinical operations Advanced understanding of regulatory requirements (ICH, FDA, EMA, etc.) and GCP guidelines Proven project management skills and experience with application of operational excellence concepts Strategic thinker with ability to translate strategy into action Skilled in cross-functional collaboration and stakeholder engagement You value flexibility, personal responsibility, and collaboration with colleagues, and you see failures as opportunities to learn, improve, and make progress Strong communication and interpersonal skills Comfortable in dynamic, fast-changing environments Fluent in English; German is a plus Your Benefits:

It's our priority to support you: Your flexibility: flexible hours | vacation account Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential Your health and lifestyle: Company bike Your mobility: Job ticket | Deutschlandticket Your life phases: Employer-funded pension | Childcare

Apply now - We look forward to your application!

Apply to our Mainz, Germany; Cambridge, US; Gaithersburg, US location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).

Job ID 9611 (please always specify if you have any questions)

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider 'HireRight'. You will be informed accordingly by your BioNTech-Recruiter.

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