(Senior-) Director Clinical Development - Late Stage & ADC Oncology

RxREVU, Inc.; Mainz; Vor Ort; EUR 145.000 - 274.000; Vollzeit

Benefits dieser Stelle

Company bike

Deutschlandticket

Employer-funded pension

Job ticket

Childcare

Zusammenfassung

BioNTech is seeking a (Senior) Director of Clinical Development to lead trial design and execution across all phases, with a focus on Immuno-Oncology. You will guide matrix teams, ensure data integrity and patient safety, and drive decisions with scientific rigor.

Based in Mainz with global collaboration, you will develop strategy, produce core documents (IBs, NDAs, CSRs), interact with health authorities, and advance programs toward regulatory approval.

Qualifikationen

• MD with strong clinical background in Immuno-Oncology or Oncology.
• Extensive experience leading clinical development programs across Phases I-III and NDA submissions.
• Expertise in advanced clinical study designs, companion diagnostics, translational modeling, biostatistics.

Aufgaben

• Lead design and execution of clinical trials across all phases.
• Oversee program leads, drive strategy and submissions.
• Ensure patient safety and data integrity in studies.
• Develop key clinical documents (IBs, NDAs, CSRs).
• Collaborate with VP to operationalize strategies and align functions.
• Represent the team in governance meetings.

Kenntnisse

MD degree

Immuno-Oncology

Regulatory submissions

Leadership

Biostatistics

Ausbildung

MD degree

Jobbeschreibung

Munich, Germany; London, United Kingdom; Mainz, Germany | full time

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.

Expected Pay Range: $168,100-$318,300 plus 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:

It's our priority to support you:

• Your flexibility: flexible hours | vacation account
• Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
• Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
• Your health and lifestyle: Company bike
• Your mobility: Job ticket | Deutschlandticket
• Your life phases: Employer-funded pension | Childcare

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.