Senior Director / Director Clinical Development, Oncology

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.

Responsibilities

• 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.

Requirements

• 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.

Qualifications

• Leadership experience in clinical development, preferably in oncology or immunology.
• Experience in regulatory affairs and compliance.
• Knowledge of clinical trial design and statistical analysis.
• Ability to manage cross-functional teams and meet tight deadlines.
• Excellent communication and interpersonal skills.

Skills

• Strong scientific and clinical background in Immuno-Oncology or Oncology.
• Expertise in clinical trial design and regulatory processes.
• Experience with digital endpoints and real-world evidence.
• Strong leadership and mentoring skills.

Benefits

BioNTech offers a competitive remuneration package which includes a salary range of $168,100-$318,300, annual bonus, and equity (dependent on company and individual performance). Additional benefits include:

• Health insurance
• Pension plan
• Flexible working hours
• Professional development opportunities
• Employee assistance program

Pay

Expected Pay Range: $168,100-$318,300 plus benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance).

Schedule

Full-time position.

Contact

To apply, please send 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. Only applications sent via our online form shall be considered.