Medical Director Clinical Development (Infectious Diseases)

Core responsibilities:

• Define the strategy and oversee the global execution of assigned Infectious Diseases programs, ensuring timely delivery
• Steer cross-functional teams, including Regulatory, Pharmacovigilance, and Biostatistics, providing clinical guidance for innovative solutions
• Guide the development and operationalization of Target Product Profiles, shaping clinical and submission plans
• Take ownership of clinical trials, leading protocol development, medical monitoring, and analysis for groundbreaking therapies
• Innovate trial design and accelerate program development to improve patient outcomes using advanced methodologies such as digital endpoints and PRO/HEOR tools
• Ensure comprehensive medical oversight, collaborating with Medical Safety and Pharmacovigilance teams to assess risks and establish Risk Management Plans
• Represent BioNTech to external stakeholders, including health authorities, investigators, and industry partners

This role contributes to advancing medicine to unlock the full potential of the immune system against infectious diseases, with the potential to improve the health of people worldwide by addressing diseases with high medical needs.

Required qualifications:

• MD or MD-PhD with a strong clinical background in infectious diseases and board certification in Infectious Diseases (or equivalent) is required
• Multiple years of experience in early- to late-stage vaccine or therapeutic development within the industry
• Expertise in clinical trial strategy, design, and execution, including Phase I/II/III studies and regulatory submissions
• In-depth knowledge of FDA, EMA, ICH, and GCP guidelines, with prior interaction with regulatory agencies preferred
• Strong leadership capabilities, including experience managing cross-functional matrices and delivering results within deadlines
• Excellent interpersonal, written, and oral communication skills in English

BioNTech offers competitive remuneration packages which are determined by the specific role, location of employment and also the selected candidate's qualifications and experience. The company is committed to the wellbeing of team members and offers a variety of benefits in support of a diverse employee base.