Mainz, Germany; Berlin, Germany; London, United Kingdom | full time | Job ID: 8580
Main Responsibilities:
- 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.
What You Have to Offer:
- 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.
- Effective stakeholder management, both in cross-functional internal and external matrix team environment.
- Demonstrated excellent leadership, communication, and presentation skills.
- Proven track record of creativity and problem-solving in a regulated environment.
- 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 solve multi-layered and dynamic tasks in flexible and changing framework conditions.
- Ability to create independent analyses and develop new solutions as well as derive or elaborate suitable next step.
- Strong communication skills.
- Service mentality – stakeholder management on eye level.
- Ability to lead various individuals of different professional backgrounds and expertise levels, with resilience to constantly changing work environment.
- Assertive, with the confidence to be a voice of authority – eager to do what is best for the team and openness to explore new topics/trends.
- High-energy and passionate outlook to the role and can influence those around them.
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; Berlin, Germany; London, United Kingdom 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 8580 (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 Recruiter.
