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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:

We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.

How to apply:

Apply now and simply send us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details by using our online form.

Please note:

• Only applications sent via our online form shall be considered.
• Only Candidates with the right qualifications and relevant experience shall be shortlisted and
• Incomplete applications shall be rejected.
• Please note that BioNTech will run a background check during the hiring process

We are looking forward receiving your application.

*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!

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