🔬 Lead Director Clinical Development & Innovation bei BioNTech AG, Mainz

The Director Clinical Development collaborates closely with the VP Clinical Development to shape clinical strategies and drive operational excellence in programs and clinical trials. This role involves designing and executing clinical trials from early stages through regulatory approval, leading a cross-functional matrix team. Responsibilities include in-depth data analysis based on a strong understanding of scientific principles and disease biology, translational expertise, and medical knowledge, ensuring patient safety and data integrity.

Your main responsibilities are:

• Collaborates with the VP of Clinical Development to guide clinical strategies and operationalize them into programs and trials.
• Leads the operational planning, content creation, execution, and delivery for our programs and studies. Manages day-to-day clinical activities for clinical trials, including protocol amendments, data review, and communication with investigators/sites.
• Takes on the responsibilities of Study Director when assigned as the clinical lead for a study; working closely with the VP Clinical Development to develop and implement the CDP.
• As study lead, communicates TPP and CDP objectives to other development functions (e.g. Regulatory, Pharmacovigilance, Statistics, etc.) and aligns objectives and expected outcomes. Translates target product profile into clinical strategy.
• Collaborates with other development functions (e.g. Regulatory, Pharmacovigilance, Statistics, etc.) to ensure clarity on clinical objectives and align objectives and expected outcomes.
• Manages medical/safety aspects of trials and risk/benefit assessments, supported by Clinical Trial Scientists and Pharmacovigilance. Works closely with Pharmacovigilance in developing risk management plans.

What you have to offer.

• M.D. with a strong scientific and clinical background in Immuno-Oncology, Oncology, and/or Infectious diseases
• Extensive experience in immuno-oncology, oncology, and/or infectious diseases in a biotech/pharmaceutical and/or academic environment, including leading clinical development activities, ideally from exploratory Phase I/II clinical trials through late stage development in Phase III and NDA submission.
• Solid understanding of clinical and scientific methods used in clinical development, from FIH to registration; experience with regulatory processes and registration is a plus.
• Hands-on experience in managing day-to-day clinical operations for the successful conduct of clinical trials.
• Experience in liaising with clinical operations and epidemiology regularly for the efficient conduct of clinical trials.
• Experience in preparing and conducting interactions with global health authorities (e.g. EMA, FDA). Participation in drug development activities leading to successful registration is an advantage.
• Strong experience in monitoring and interpreting safety and efficacy clinical trial data, ensuring appropriate liaison for trial medical and patient safety issues.
• Functional and/or disciplinary leadership experience with a proven track record of leading teams 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; London, United Kingdom; Munich, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1... [Vollständig anzeigen] (Monday-Friday from 12 PM to 4 PM CET).

Job ID 9313 (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.