Associate Director, Patient Operations (m/w/d)
Mainz, Germany; Berlin, Germany; London, United Kingdom | full time | Job ID:8580
- Contribute to the global program that establishes and manages the network of sample collection centers supporting individualized therapies.
- Oversee the project planning associated with the onboarding process of sample collection centers, including building, tracking, and reporting.
- Ensure alignment with Clinical, Commercial, Manufacturing, Quality, and other internal teams regarding the individualized therapy treatment journey.
- Develop both internal and external-facing training materials for teams and sample collection centers.
- Oversee the training program for sample collection centers on collection processes in coordination with Clinical Operations.
- Lead cross-functional continuous improvement initiatives to enhance the robustness and efficiency of the individualized therapy treatment journey, including the implementation and development of state-of-the-art processes and new technology solutions. This includes making critical decisions in alignment with internal and external stakeholders.
- Contribute to the cross-functional prioritization of site slot allocation and coordinate with Product Supply, Manufacturing, and Clinical Operations on related manufacturing capacity.
- Support cross-functional scheduling and coordination meetings to ensure timely execution and product delivery to patients.
- Partner with Clinical Operations and Commercial teams to enhance patient supply in the clinical setting and support developing the future commercial patient journey operating model.
- Monitor trends and identify improvement opportunities for the Patient Operations team.
- Provide operational support as a process expert for patient operations activities.
- Conduct risk assessments, lessons learned sessions, and continuous process improvements.
- Represent Clinical Trial Supply Management in internal and external project and trial teams.
- This position may include people management responsibility, which would include the hiring, training, and performance of operations specialists and managers.
- Degree in pharmacy, chemistry, biotechnology, biochemistry, engineer, nursing, supply chain management, logistics or related discipline.
- Broad and/or in-depth and special task-specific expertise and skills.
- Relevant professional experience (usually +5 years) in Pharmaceutical or Biotech or any other equivalent industry setting (e.g. healthcare).
- Experience supporting individualized therapies, such as CAR-T Therapy or Individualized Vaccines.
- In-depth understanding of the clinical site onboarding, training, and activation process for individualized therapies.
- Proven experience in supporting clinical trials, submissions to health authorities, and inspection readiness activities.
- Knowledge in patient scheduling, order management, slot allocation, and logistics coordination for individualized therapies.
- Profound skills with electronic systems supporting Patient Operations Scheduling & Logistics processes, Chain of Identity process controls, and standard office software (e.g., MS Office).
- Experience in a customer service or support role is essential.
- Demonstrated excellent leadership, communication, and presentation skills.
- Experience in writing regulatory documents such as SOPs.
- Project Management experience.
- Demonstrated quality management experience.
- Documented experience in handling deviations, changes, and CAPA processes.
- Business-professional English language skills are required; proficiency in additional languages is an advantage.
- Decision-making skills based on experiential knowledge, paired with strategic thinking and negotiation abilities.
- Ability to create independent analyses and develop new solutions as well as derive or elaborate suitable next step.
- Strong communication skills.
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

Kontaktperson:
BioNTech SE HR Team