Senior Director Clinical Development Personalized Cancer Vaccines London, United Kingdom; Berlin, Germany; Mainz, Germany; Munich, Germany | full time | Job ID:6950 We are seeking an experienced Senior Director Clinical Development to lead clinical strategies and oversee the design and execution of clinical trials for personalized cancer vaccines. This role is critical in driving programs from early-stage development through late-stage clinical trials and regulatory approval. The ideal candidate will have extensive experience in late-stage development and a strong background in Immuno-Oncology, with expertise in mRNA immunotherapies, CAR-T or checkpoint inhibitors or similar areas being highly preferred. Strategic Leadership: Define and execute clinical development strategies, including the creation of clinical development plans (CDPs) and Target Product Profiles (TPPs) for assigned programs. Clinical Trial Oversight: Lead the design, execution, and medical aspects of clinical trials, ensuring patient safety, data integrity, and risk-benefit assessments. Late-Stage Development Expertise: Drive confirmatory Phase III trial designs, regulatory dossier preparation, and submission activities. Cross-Functional Collaboration: Partner with Clinical Operations, Pharmacovigilance, Regulatory Affairs, and other teams to ensure seamless program execution. Innovation: Accelerate program and trial design with innovative approaches, such as digital endpoints, synthetic control arms, and real-world evidence (RWE). Regulatory Engagement: Represent the program in global health authority interactions (FDA, EMA, etc.) and ensure high-quality clinical documentation for regulatory submissions. Leadership: Mentor and supervise clinical team members, fostering collaboration and driving performance across matrix teams. M.D. with a strong scientific and clinical background in Immuno-Oncology or Oncology. Minimum 8-10 years in Immuno-Oncology/Oncology, including leading clinical development programs from Phase I/II through late-stage Phase III and NDA submission. Proven expertise in late-stage development and regulatory submissions. Experience in mRNA immunotherapies, CAR-T or checkpoint inhibitors or similar areas is highly preferred. Deep understanding of clinical trial design, companion diagnostics, translational modeling, and biostatistics. Strong leadership skills with experience managing global matrix teams and mentoring clinical professionals. Demonstrated ability to drive innovation in clinical trial design and execution. BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.