Director* Clinical Development
Open for hire at one of the following locations – Mainz Goldgrube, Cambridge Erie Street, Gaithersburg, London. - Job ID: 6240
Become a member of the BioNTech Family!
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.
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.
Director* Clinical Development
The Director Clinical Development will work hand-in-hand with the VP Clinical Development to implement clinical strategies and operationalize in both programs and clinical trials. He/ She will work on the design and execution of clinical trials from early to late stage development through regulatory approval, horizontally leading a matrix team. This includes thorough data interpretation based on deep scientific and disease biology understanding, translational expertise and medical knowledge, including patient safety and data integrity
Your main responsibilities are:
- Works hand-in-hand with the VP of Clinical Development to guide clinical strategies and their operationalization into programs and trials.
- Drives the operational planning, content, execution and delivery for our programs and studies. Manages the day-to-day clinical activities for our clinical trials, including managing protocol amendments, overseeing data review activities, and communicating with investigators/sites as appropriate.
- Assumes the responsibilities of Study Director when assigned as the clinical lead for a study; works hand-in-hand with the VP Clinical Development to develop and implement the CDP.
- As study lead, articulates TPP and CDP objectives to other development functions (e.g. Regulatory, Pharmacovigilance, Statistics, etc.) and drives alignment on objectives and expected outcomes. Drives translation of target product profile into clinical strategy.
- Collaborates with other development functions (e.g. Regulatory, Pharmacovigilance, Statistics, etc.) to support clarity on clinical objectives and drive alignment on objectives and expected outcomes.
- Responsible for medical/safety aspects of trials and risk/benefit assessments, supported by Clinical Trial Scientists and Pharmacovigilance. Works closely with Pharmacovigilance in the development of risk management plans.
What you have to offer.
- M.D. with strong scientific and clinical background in Immuno-Oncology, Oncology and/or Infectious diseases
- Several years of relevant experience in immuno-oncology, oncology and/or infectious diseases in a biotech/pharmaceutical and/or academic environment, including leadership of clinical development activities, ideally from exploratory Phase I/II clinical trials through late stage development in Phase III and NDA submission.
- Good understanding of clinical and scientific methods and approaches used in clinical development, from FIH to registration; experience with regulatory processes and registration a plus.
- Hands-on experience in managing the day-to-day clinical operations for the successful conduct of clinical trials.
- Experience in liaising with clinical operations and epidemiology on a regular basis for the efficient conduct of clinical trials.
- Experience in preparing and conducting interactions with global health authorities (e.g. EMA, FDA). Participation in drug development activities leading to successful registration is an advantage.
- Strong experience in monitoring and interpreting safety and efficacy clinical trial data and ensuring appropriate liaison for trial medical and patient safety issues.
- Functional and/or disciplinary leadership experience with a proven track record of leading teams is a plus.
Benefits for you
BioNTech 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.
Click here to find out more about what we do, the careers we offer and also the benefits we provide.
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.
Have we kindled your pioneering spirit?
This vacancy is to be hired at one of the following locations – Mainz Goldgrube, Cambridge Erie Street, Gaithersburg, London. Apply now for your preferred job and location through our careers site.
*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!