Life Scientist - Clinical Trials (m / f / d)

BioNTech SE; Mainz; Vor Ort; EUR 100.000 - 150.000; Vollzeit

Zusammenfassung

A leading company in the biotech sector is seeking a Senior Director of Clinical Science to oversee clinical trial design and execution. This role involves collaboration with cross-functional teams and managing clinical science personnel, requiring extensive experience in drug development, particularly in Oncology. The successful candidate will benefit from a flexible work environment and various employee support initiatives.

Leistungen

Flexible hours and vacation options

Inclusive culture

Company bike for health and lifestyle

Employer-funded pension and childcare support

Qualifikationen

• 12+ years industry experience with team management.
• Strong knowledge of GCP and drug development (Phase 1-3).
• Experience with global clinical study setup and execution.

Aufgaben

• Collaborate with Clinical Development Lead to design clinical trials.
• Oversee clinical trials ensuring compliance with protocols.
• Create and review study documents and contribute to publications.

Kenntnisse

GCP knowledge

Drug development

Clinical data collection

Influencing in matrix environment

Multitasking under pressure

Effective prioritization

Fluent in English

Ausbildung

Degree in life sciences, healthcare, or nursing

Advanced degree preferred

Tools

EDC

Excel

Jobbeschreibung

Senior-) Director, Clinical Science (m / w / d)

Mainz, Germany; London, United Kingdom; Munich, Germany | full time | Job ID : 8980

Responsibilities

1. Collaborate with the Clinical Development Lead to design clinical trials assessing safety and efficacy of investigational drugs, including developing protocols, identifying patient populations, and selecting study endpoints.
2. Support the Clinical Development Lead in overseeing clinical trials to ensure compliance with protocols, regulatory standards, and ethical guidelines. This includes monitoring progress, reviewing data, and managing adverse events.
3. Create and review study documents such as protocols, Investigator’s Brochures, briefing books, safety updates, and submission dossiers. Contribute to clinical trial publications if applicable.
4. Address regulatory and health authority queries under guidance, ensuring guideline compliance.
5. Assist in developing Clinical Development Plans, Integrated Evidence Plans, and clinical components of Target Product Profiles (TPP).
6. Work with cross-functional teams (clinical operations, biostatistics, regulatory affairs, medical affairs) to execute development programs successfully.
7. Build relationships with Principal Investigators (PIs) and Key Opinion Leaders (KOLs) in relevant therapeutic areas.
8. Develop training materials on clinical protocols and disease indications; train study team members, CRO staff, and investigators.
9. Present at key meetings such as SIVs, investigator meetings, and IDMC meetings.
10. Collaborate with safety and pharmacovigilance teams on safety evaluations, signal detection, and contributing to safety reports and patient narratives.
11. Support regulatory activities, including preparing for meetings with agencies.
12. Participate in study-level meetings like Investigator Meetings and Data Monitoring Committees.
13. Guide data review strategies, ensuring consistent implementation of protocols across sites and countries, including support for CRF development and data capture tools.
14. Oversee medical data review and analysis to evaluate drug safety and efficacy, working with biostatistics to develop analysis plans and interpret results.
15. Improve data review processes through innovative analysis tools and continuous improvement initiatives.
16. Manage clinical science personnel, including development, coaching, and performance evaluations.

Qualifications

• Degree in life sciences, healthcare, or nursing; advanced degree preferred.
• 12+ years industry experience, with prior team management experience.
• Strong knowledge of GCP and drug development (Phase 1-3), preferably in Oncology / Immuno-Oncology.
• Experience with global clinical study setup, organization, and execution in pharma, CRO, or academic settings.
• Knowledge of clinical data collection/reporting systems (e.g., EDC, Excel) and process improvement.
• Ability to influence in a matrix environment.
• Flexible, adaptive working style; capable of multitasking under high pressure.
• Effective prioritization skills.
• Fluent in English (written and spoken).

Your Benefits: We Support You

• Flexible hours and vacation options.
• Inclusive culture where your voice matters, opportunities to impact, and support for your growth.
• Company bike for health and lifestyle.
• Employer-funded pension and childcare support.