(Senior-) Medical Director, Clinical Development

<p><em><span><span><span>Open for hire at one of the following locations –  Mainz Goldgrube, Cambridge Erie Street, London. - Job ID: 6963</span></span></span> </em></p> <p><span></span></p> <p> </p> <p><span><b><span>Join our team of pioneers!</span></b></span><br/> <br/> <span><span>As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.<br/>  <br/> We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.</span></span></p> <p><br/>  </p> <p><b><span><span><span>(Senior-) Medical Director, Clinical Development</span> </span></span></b></p> <p> </p> <p> </p> <p>The Senior Director Clinical Development will collaborate closely with the VP of Clinical Development to lead clinical strategies for assigned programs. This role involves overseeing the design and execution of clinical trials from early to late stages, ensuring data integrity, patient safety, and regulatory approval. You will lead a matrix team and apply your deep understanding of scientific, medical, and disease biology to guide decisions.</p> <p><b>Key Responsibilities:</b></p> <ul> <li>Oversee and steer clinical trial design and execution, developing clinical plans for new compounds and leading towards regulatory approval.</li> <li>Collaborate with the VP to operationalize clinical strategies for assigned portfolios.</li> <li>Lead program strategy, development plans, and submission processes.</li> <li>Serve as Program Lead, guiding core teams and aligning objectives across functions.</li> <li>Ensure medical and safety aspects of studies, including risk-benefit assessments and medical queries.</li> <li>Work closely with Clinical Operations to ensure patient-centric drug development.</li> <li>Drive innovation in trial design, leveraging digital endpoints and real-world evidence.</li> <li>Prepare key clinical documents (e.g., Investigator’s Brochures, NDAs) and ensure high-quality medical content in Clinical Study Reports.</li> <li>Manage relationships with external stakeholders and represent the team in governance meetings.</li> </ul> <p> </p> <p><b>What you have to offer.</b></p> <ul> <li>M.D. with strong scientific and clinical background in Immuno-Oncology, Oncology</li> <li>Several years of experience within Immuno-Oncology, Oncology 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 submission.</li> <li>Thorough understanding of the clinical and scientific methods and approaches used in clinical development studies, as</li> <li>novel clinical study designs, application of companion diagnostics for patient selection, clinical pharmacology/ translational modeling and biostatistics.  Complemented with several years of experience on confirmatory PH3 trial design and respective dossier preparation and submission activities.</li> <li>Experienced in global health authority interactions (EMA, FDA, MHRA, CDE). Having participated or led a drug development program to successful registration is an advantage.</li> <li>Strong medical experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects.</li> <li>Ability to apply situational management style to both mentor and accelerate capabilities of its reports</li> </ul> <h2><br/>  </h2> <h2><span><span><b><span>Benefits for you</span></b></span></span></h2> <p><b>BioNTech </b><span><span>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.</span></span></p> <p><span><span>Click <a href="http://www.biontech.com/int/en/home/careers/working-at-biontech.html"><span>here</span></a> to find out more about what we do, the careers we offer and also the benefits we provide.</span></span><br/> <span><em>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.</em></span></p> <p> </p> <h2><span><span><b><span>Have we kindled your pioneering spirit? </span></b></span></span></h2