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

Gudejobs; Deutschland; Remote; EUR 146.000 - 276.000; Vollzeit

Benefits dieser Stelle

Flexible hours

Digital Learning

Employer-funded pension

Company bike

Deutschlandticket

Childcare

Zusammenfassung

BioNTech seeks a (Senior) Director of Clinical Development in Munich to lead trial design across all phases, ensure data integrity, patient safety and regulatory readiness for innovative oncology programs.

You will collaborate with senior leadership to operationalize strategies, guide core teams, oversee safety assessments and develop key documents (Investigator’s Brochures, NDAs, CSRs) while engaging external stakeholders and health authorities.

Qualifikationen

• MD with strong scientific and clinical background in Immuno-Oncology or Oncology.
• Experience leading clinical development programs across Phases I–III, including NDA submissions.
• Knowledge of advanced clinical study designs, companion diagnostics for patient selection, translational modeling, biostatistics, and confirmatory Phase III trial design.
• Experience interacting with health authorities (EMA, FDA) globally; successful registrations advantageous.
• Strong medical acumen in monitoring safety/efficacy data and patient-centric drug development.

Aufgaben

• Lead clinical trial design from early exploration through late-stage development and regulatory approval.
• Collaborate with the VP to operationalize clinical strategies for assigned portfolios and ensure cross-functional alignment.
• Serve as Program Lead, guiding core teams, driving strategy, and preparing submission processes.
• Oversee patient safety, risk-benefit assessments, and medical queries.
• Innovate in trial design with digital endpoints and real-world evidence to improve outcomes.
• Develop key clinical documents (Investigator’s Brochures, NDAs, CSRs).
• Build relationships with external stakeholders and represent the team in governance meetings.

Kenntnisse

MD degree

Clinical development leadership

Immuno-Oncology expertise

Regulatory engagement (EMA/FDA)

Biostatistics knowledge

Ausbildung

MD degree

Jobbeschreibung

Munich, Germany; London, United Kingdom; Mainz, Germany | full time | Job ID:11648

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

Job ID 11648(please always specify if you have any questions)

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.

Inspired? Become part of #TeamBioNTech.

BioNTech, the story

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encouragecreativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

BioNTech - As unique as you

www.biontech.com