(Senior-) Director Clinical Development (all genders)

<p>Mainz, Germany   |   full time   |   hybrid   |   Job ID: 5836 </p> <p> </p> <p> </p> <p><span><span><span><span><span><span><span>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. </span></span></span></span></span></span></span><span><span><span><span><span><span><span>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:</span></span></span></span></span></span></span></p> <ul> <li><span><span><span><span><span><span><span>Immuno-Oncology</span></span></span></span></span></span></span></li> <li><span><span><span><span><span><span><span>Antibody Drug Conjugates</span></span></span></span></span></span></span></li> <li><span><span><span><span><span><span><span>Cell Therapy</span></span></span></span></span></span></span></li> <li><span><span><span><span><span><span><span>Individualized Cancer Vaccines</span></span></span></span></span></span></span></li> </ul> <p><span><span><span><span><span><span><span>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. </span></span></span></span></span></span></span></p> <p> </p> <p><span><span><b><span>Your primary responsibilities are: </span></b></span></span></p> <ul> <li><span><span><span><span>Work hand-in-hand with the VP of Clinical Development to steer clinical strategies and their operationalization of portfolios and platforms</span></span></span></span></li> <li><span><span><span><span><span>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</span></span></span></span></span></li> <li><span><span><span><span><span>Create and translate Target Product Profile into clinical strategy</span></span></span></span></span></li> <li><span><span><span><span><span>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</span></span></span></span></span></li> <li><span><span><span><span><span>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</span></span></span></span></span></li> <li><span><span><span><span><span>Supervise ongoing medical data review</span></span></span></span></span></li> <li><span><span><span><span><span>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</span></span></span></span></span></li> <li><span><span><span><span><span>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)</span></span></span></span></span></li> <li><span><span><span><span><span>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</span></span></span></span></span></li> <li><span><span><span><span><span>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</span></span></span></span></span></li> <li><span><span><span><span><span>Establish, lead, and manage relationships with key external stakeholders (industry partners, key opinion leaders, health authorities)</span></span></span></span></span></li> <li><span><span><span><span><span>Represent the team to decision/governance meetings, senior management, or advisory boards as applicable</span></span></span></span></span></li> <li><span><span><span><span><span>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</span></span></span></span></span></li> </ul> <p><s