Mainz, Germany | full time | Job ID: 5836

We are looking for you to join us as (Senior-) Medical Director to help drive our cutting-edge oncology pipeline. In this role you are working closely with our Chief Medical Officer and her leadership team and are truly at the heart of the BioNTech story. We can fill more than one role with different focus areas and are looking for candidates that bring in-depth experience in either of the following areas:

• Immuno-Oncology
• Antibody Drug Conjugates
• Cell Therapy
• Individualized Cancer Vaccines

In either area we are looking for candidates who have consistent end-to-end experience with clinical trials. These role requires an absolute team player that brings an extraordinary degree of flexibility and accountability to thrive in our fast-paced Pioneer culture.

Your primary responsibilities are:

• Work hand-in-hand with the VP of Clinical Development to steer clinical strategies and their operationalization of portfolios and platforms
• Own the strategy formulation and operational planning, content, execution, and delivery for assigned programs and will be a key driver of the integrated development, submission, and publication plan
• Create and translate Target Product Profile into clinical strategy
• Assume Program Lead responsibilities in the assigned programs, in liaison with the responsible program manager, and in that role, articulate targets of TPP and CDP to other Development functions (e.g., Regulatory, Biostatistics, etc.) and drive alignment on objectives and expected outcomes. Lead the program core team
• Responsible for study medical/ safety aspects and risk-benefit assessments supported by the study clinical scientist and Pharmacovigilance, collaborating closely with the Medical Safety and Pharmacovigilance team on development of Risk Management Plans
• Supervise ongoing medical data review
• Ensure at the program level, that the Clinical Development team works hand-in-hand with the Clinical Operations team for patient centric drug development, ensuring balancing of high medical quality, trial complexity, as well as time and cost considerations
• Take ownership together with partner functions in Development on the acceleration of program and trial design and innovation for the patient (e.g., digital endpoints, synthetic control arms, RWE/HEOR, PRO, Medical Affairs)
• Own and ensure preparation for clinical sections of key documents, including Investigator's Brochures, IND summary documents, CTAs, responses to questions from regulatory authorities, IRBs and ethics committees, and NDAs
• Oversee Clinical Study Report (CSR) medical content meets high quality expectations on medical standards, provides respective guidance to other members of the Clinical Development team
• Establish, lead, and manage relationships with key external stakeholders (industry partners, key opinion leaders, health authorities)
• Represent the team to decision/governance meetings, senior management, or advisory boards as applicable
• In programs with multiple studies, assume matrix line management and mentoring of clinicians responsible for those studies. Actively contribute to recruiting, onboarding and continuous capability building of the program clinical development team

What you have to offer:

• M.D. and/or M.D. Ph.D with strong scientific and clinical background in Immuno-Oncology or Oncology
• Minimum of 10 years of experience within either Immuno-Oncology, ADCs, Cell Therapy or Individualized Cancer Vaccines at the biotech/pharmaceutical and the academic setting, including leading clinical development programs from exploratory Phase I/II clinical studies through late-stage development in Phase III and NDA/BLA submission
• Extensive expertise in clinical development studies in pharmaceutical / biotech companies, including novel study design, companion diagnostics, clinical pharmacology, translational modeling, biostatistics, and Phase 3 trial design, with significant experience in dossier preparation and submission
• The ideal candidate has been consistently involved in clinical trials from beginning to end
• Experienced in global health authority interactions (EMA, FDA, CDE). Having participated or led a drug development program to successful registration is an advantage
• Strong medical experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects
• Demonstrated leadership experience and several years matrix management experience in a global organization. Ability to lead horizontally and drive execution of workplans in collaboration with other functions, without having formal line management authority
• High level of comfort and demonstrated successes working in a matrix environment (global and cross-functional), including contributing to establishing clarity and structures and driving state of the art collaborations with external academic and industry partners
• A genuine interest and understanding of the science supporting the clinical development programs. Confident to discuss and present scientific and mechanistic aspects of drug development
• Proficiency in English (written and spoken)

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 location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6781 9855 211 (Monday-Friday from 12 PM to 4 PM CET).

Job ID 5836 (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.