(Senior-) Director, Clinical Development

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(Senior-) Director, Clinical Development

Mainz, Germany; Cambridge, US; Gaithersburg, US; London, United Kingdom; Munich, Germany   |   full time   |   Job ID: 9676 

The (Senior-) Director Clinical Development will collaborate closely with the VP of Clinical Development to lead clinical strategies for assigned programs. This role involves overseeing the design and execution of clinical trials from early to late stages, ensuring data integrity, patient safety, and regulatory approval. You will lead a matrix team and apply your deep understanding of scientific, medical, and disease biology to guide decisions.

**Key Responsibilities:**

• Oversee and steer clinical trial design and execution, developing clinical plans for new compounds and leading towards regulatory approval.

• Collaborate with the VP to operationalize clinical strategies for assigned portfolios.

• Lead program strategy, development plans, and submission processes.

• Serve as Program Lead, guiding core teams and aligning objectives across functions.

• Ensure medical and safety aspects of studies, including risk-benefit assessments and medical queries.

• Work closely with Clinical Operations to ensure patient-centric drug development.

• Drive innovation in trial design, leveraging digital endpoints and real-world evidence.

• Prepare key clinical documents (e.g., Investigator’s Brochures, NDAs) and ensure high-quality medical content in Clinical Study Reports.

• Manage relationships with external stakeholders and represent the team in governance meetings.

**What you have to offer.**

• M.D. with strong scientific and clinical background in Immuno-Oncology, Oncology

• Several years of experience within Immuno-Oncology, Oncology at the biotech/pharmaceutical and the academic setting, 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, MHRA, 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.

• Ability to apply situational management style to both mentor and accelerate capabilities of its reports

**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 

**Apply now - We look forward to your application!**

Apply to our Mainz, Germany; Cambridge, US; Gaithersburg, US; London, United Kingdom; Munich, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).

Job ID 9676 (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, encourage creativity, 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  

Apply now »

*

Search by Keyword
*
*

Show More Options

Loading...

Site Location

All

Business Area

All

Career Level

All

Select how often (in days) to receive an alert:

* Create Alert

×

Select how often (in days) to receive an alert:

Apply now »

##
(Senior-) Director, Clinical Development

Mainz, Germany; Cambridge, US; Gaithersburg, US; London, United Kingdom; Munich, Germany   |   full time   |   Job ID: 9676 

The (Senior-) Director Clinical Development will collaborate closely with the VP of Clinical Development to lead clinical strategies for assigned programs. This role involves overseeing the design and execution of clinical trials from early to late stages, ensuring data integrity, patient safety, and regulatory approval. You will lead a matrix team and apply your deep understanding of scientific, medical, and disease biology to guide decisions.

**Key Responsibilities:**

• Oversee and steer clinical trial design and execution, developing clinical plans for new compounds and leading towards regulatory approval.

• Collaborate with the VP to operationalize clinical strategies for assigned portfolios.

• Lead program strategy, development plans, and submission processes.

• Serve as Program Lead, guiding core teams and aligning objectives across functions.

• Ensure medical and safety aspects of studies, including risk-benefit assessments and medical queries.

• Work closely with Clinical Operations to ensure patient-centric drug development.

• Drive innovation in trial design, leveraging digital endpoints and real-world evidence.

• Prepare key clinical documents (e.g., Investigator’s Brochures, NDAs) and ensure high-quality medical content in Clinical Study Reports.

• Manage relationships with external stakeholders and represent the team in governance meetings.

**What you have to offer.**

• M.D. with strong scientific and clinical background in Immuno-Oncology, Oncology

• Several years of experience within Immuno-Oncology, Oncology at the biotech/pharmaceutical and the academic setting, 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, MHRA, 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.

• Ability to apply situational management style to both mentor and accelerate capabilities of its reports

**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 

**Apply now - We look forward to your application!**

Apply to our Mainz, Germany; Cambridge, US; Gaithersburg, US; London, United Kingdom; Munich, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).

Job ID 9676 (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, encourage creativity, 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  

Apply now »