BioNTech SE
55131 Mainz am Rhein - Deutschland
Medical Advisor
Arbeit
Vollzeit
ab 06.01.2026
Beschreibung
(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 matr... weiter lesen
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 matr... weiter lesen
(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.
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.
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
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
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.
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.
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
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
Ref-Nr.: 8240937
Aktualisiert:
14.01.2026
Quelle: Bundesagentur für Arbeit
weitere Infos Rechtliche Hinweise zur Nutzung
Ob die Stelle noch verfügbar ist und weitere Informationen findest du direkt auf der Website der Bundesagentur für Arbeit. Bitte beachte: OPROMA ist nicht der Anbieter dieser Stelle und kann keine Auskünfte geben.
weitere Infos Rechtliche Hinweise zur Nutzung
Ob die Stelle noch verfügbar ist und weitere Informationen findest du direkt auf der Website der Bundesagentur für Arbeit. Bitte beachte: OPROMA ist nicht der Anbieter dieser Stelle und kann keine Auskünfte geben.
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