Medical Director – Clinical Development, Infectious Diseases
Mainz, Rheinland-Pfalz, Germany
Full Time
4 hours ago
No H1B
Key skills
Google Cloud PlatformGCPGoogle CloudRisk ManagementCommunication
About this role
Role Overview
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
Requirements
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
Excellent interpersonal, written, and oral communication skills in English