As a part of our team of more than 1.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age: Amongst multiple programs in the pipeline, we are conducting research on a Covid-19 vaccine in our project “Lightspeed” based on our mRNA-technologies. Furthermore, we are pioneers in the development of individualized cancer therapies and in the combat against other diseases.
We aim to achieve life-changing successes for patients by being innovative, passionate and united,so 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.
Medical Director* Immuno-Oncology
As part of the clinical development team, you will serve as the clinical lead for clinical studies within the COVID-19 Lightspeed project and/or in the Oncology pipeline programs. You will lead the strategic direction of assigned studies and will be responsible for the design and execution of clinical studies/programs from early to late stage development through regulatory approval: Your main responsibilities are:
- Strategic and operational planning, content, execution and delivery for studies and act as a key driver of the integrated development, submission and publication plan
- Program Lead responsibilities when responsible for a program, in liaison with the responsible program manager; leading the program core team
- Creating and translating Target Product Profile into clinical strategy
- Study medical/safety aspects and risk-benefit assessments supported by the study Medical expert and Pharmacovigilance; collaborating on the development of Risk Management Plans
- 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
- Ensuring Clinical Study Report (CSR) medical content adheres to acceptable medical standards
- Establishing, leading, and managing relationships with key external stakeholders (industry partners, Key Opinion Leaders, health authorities)
- Representing the team to decision/governance meetings, senior management, or advisory boards as applicable
- Supervising/mentoring multiple studies/clinicians
What you have to offer.
- M.D./Ph.D. with strong scientific and clinical background in Immuno-Oncology and/or Infectious diseases
- Extensive experience within Immuno-Oncology and/or Infectious diseases, including leading clinical development programs from exploratory Phase I/II clinical studies through late stage development and NDA submission
- Thorough understanding of novel clinical study designs, application of companion diagnostics for patient selection, clinical pharmacology/translational modeling and biostatistics
- Experienced in global health authority interactions (EMA, FDA, CDE). Having participated or led a drug development program to registration is an advantage and preferred
- Strong medical experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects
- Leadership experience in a matrix environment
- An ability to strategize and lead a goal oriented clinical development team
- The capacity to discuss and present scientific and mechanistic aspects of drug development
- Proficiency in English (written and spoken)
Benefits for you.
- Company Pension Scheme
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation
... and much more.
Have we kindled your pioneering spirit?
Then apply now for our location Mainz and simply send us your application documents using our online form.
If you have any further questions, Alexandra Hilsbos will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon).
- BioNTech does not differentiate on the basis of gender, race, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer