Associate Director Clinical Operations Process Improvement

BioNTech SE; Deutschland; Vor Ort; EUR 80.000 - 110.000; Vollzeit

Zusammenfassung

A leading biotechnology company in Mainz, Germany is seeking an Associate Director Process Improvement to enhance operational initiatives related to clinical trials. The ideal candidate has over 8 years of experience in pharma/biotech, a strong grasp of clinical operations, and excellent project management skills. This role supports a culture of continuous improvement and strategic collaboration, offering flexible hours and a dynamic workplace.

Leistungen

Flexible hours

Digital Learning and development

Company bike

Employer-funded pension

Childcare support

Qualifikationen

• Minimum 8 years of experience in pharma/biotech/CRO.
• Strong understanding of drug development and clinical operations.
• Advanced understanding of regulatory requirements (ICH, FDA, EMA).

Aufgaben

• Support planning and development of process improvement initiatives.
• Drive a continuous improvement culture in clinical operations.
• Analyze root causes for identified issues with Quality Assurance.

Kenntnisse

Project management

Cross-functional collaboration

Strong communication skills

Strategic thinking

Fluency in English

Ausbildung

Bachelor's/Master's degree in business, science, or healthcare

Jobbeschreibung

Overview

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.

Responsibilities

• 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

Qualifications

• 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

Benefits

• 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

Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: [phone] (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.

About BioNTech

Inspired? Become part of #TeamBioNTech. BioNTech, the story: We are a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival. Our focus includes addressing diseases with high medical needs like cancer and various infectious diseases. BioNTech emphasizes a dynamic workplace that embraces diversity, fosters innovation, and develops business strategies driven by our shared passion for advancing medicine. Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other personal characteristics. We are committed to creating a diverse and inclusive work environment and are an equal opportunity employer.

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