Executive Director, Clinical Development
Cambridge, US; Gaithersburg, US; New Jersey, US | full time | Job ID: 10147
About the Role:
As Executive Director Clinical Development, you will be at the forefront of steering clinical strategies and their operationalization for assigned programs. This role directly contributes to BioNTech's mission by leading the strategic direction of platforms and programs, ensuring clinical trials are designed and executed with precision from early to late-stage development through regulatory approval. You will work within a dynamic team environment, collaborating closely with multidisciplinary teams globally to drive innovation, ensure patient safety, and uphold data integrity.
Your Contribution:
- Lead and manage a team of medical professionals representing Clinical Development within global teams, including Core Teams, Project Teams, and Study Teams.
- Oversee the design and execution of clinical trials, ensuring alignment with BioNTech’s strategic goals and regulatory requirements.
- Supervise the creation of integrated evidence generation plans paving paths toward regulatory approval.
- Represent BioNTech in collaborations with industry partners, academic investigators, advisory meetings with opinion leaders, and interactions with Health Authorities.
- Provide medical expertise across functions such as business development, discovery, non-clinical development, medical communications, quality assurance, clinical operations, biostatistics, regulatory affairs, and drug safety.
Qualifications:
Education
- Medical Doctor (MD) with a strong scientific background in Immuno-Oncology, Oncology, or Infectious Diseases.
Experience
- Minimum of 8 + years of relevant experience in clinical R&D within Immuno-Oncology, Oncology and/or Infectious diseases at the biotech/pharmaceutical and the academic setting at an international level, 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, 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.
- Demonstrated leadership experience as a program lead and several years (> 4 years) line management experience in global matrix organization. Ability to lead horizontally and drive execution of workplans in collaboration with other functions, without having formal line management authority.
- Proficiency in English (written and spoken).
Join us at BioNTech to contribute your expertise towards developing groundbreaking treatments that address unmet needs in Oncology and Infectious Diseases. Apply today!
*Expected US Pay Range: $245,000 to $392,000/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.
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.