(Senior-) Medical Director, Clinical Development

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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.

(Senior-) Medical Director, Clinical Development 

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.

Key Responsibilities:

• Oversee and steer clinical trial design and execution, developing clinical plans for new compounds and leading towards regulatory approval.
• Collaborate with the VP to operationalize clinical strategies for assigned portfolios.
• Lead program strategy, development plans, and submission processes.
• Serve as Program Lead, guiding core teams and aligning objectives across functions.
• Ensure medical and safety aspects of studies, including risk-benefit assessments and medical queries.
• Work closely with Clinical Operations to ensure patient-centric drug development.
• Drive innovation in trial design, leveraging digital endpoints and real-world evidence.
• Prepare key clinical documents (e.g., Investigator’s Brochures, NDAs) and ensure high-quality medical content in Clinical Study Reports.
• Manage relationships with external stakeholders and represent the team in governance meetings.

What you have to offer.

• M.D. with strong scientific and clinical background in Immuno-Oncology, Oncology
• 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.
• Thorough understanding of the clinical and scientific methods and approaches used in clinical development studies, as
• 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.
• Experienced in global health authority interactions (EMA, FDA, MHRA, CDE). Having participated or led a drug development program to successful registration is an advantage.
• Strong medical experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects.
• Ability to apply situational management style to both mentor and accelerate capabilities of its reports

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!

BioNTech - As unique as you

www.biontech.com