Senior Director/Director Clinical Development
New Jersey, US; Cambridge, US; Gaithersburg, US | full time | Job ID: 9682
About the Role
As a (Senior-) Director of Clinical Development at BioNTech, you will collaborate closely with the VP of Clinical Development to drive innovative strategies for assigned programs. In this pivotal role, you will oversee the design and execution of clinical trials across all phases, ensuring data integrity, patient safety, and regulatory approval. Leveraging your deep expertise in Immuno-Oncology and Oncology, you will lead matrix teams to deliver impactful results while guiding decisions with scientific rigor and medical insight. Join us to shape the future of medicine through cutting-edge research and development.
Your Contribution
- Lead clinical trial design to develop plans for new compounds from early exploratory studies through late-stage development and regulatory approval.
- Collaborate with the VP to operationalize clinical strategies for assigned portfolios and ensure alignment across functions.
- Serve as Program Lead, guiding core teams, driving program strategy, and preparing submission processes.
- Ensure patient safety by overseeing medical aspects of studies, conducting risk-benefit assessments, and addressing medical queries.
- Innovate in trial design, leveraging digital endpoints and real-world evidence to enhance study outcomes.
- Develop key clinical documents, including Investigator’s Brochures, NDAs, and high-quality Clinical Study Reports.
- Build strong relationships with external stakeholders while representing the team in governance meetings.
A Good Match
- M.D. degree with a robust scientific and clinical background in Immuno-Oncology or Oncology.
- Extensive experience leading clinical development programs across Phases I–III, including NDA submissions.
- Expertise in advanced clinical study designs, companion diagnostics for patient selection, translational modeling, biostatistics, and confirmatory Phase III trial design.
- Proven experience interacting globally with health authorities (e.g., EMA, FDA), with successful registration being advantageous.
- Strong medical acumen in monitoring safety/efficacy data and managing patient-centric drug development processes.
- Exceptional leadership skills to mentor teams while accelerating capabilities through situational management styles.
BioNTech offers a collaborative environment where innovation meets purpose. If you are passionate about advancing therapies that make a difference in patients' lives, we invite you to join our mission-driven team.
Your Benefits:
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.
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.
How to apply:
Apply now by sending 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 via our online form.
Please note:
Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
We are looking forward receiving your application.