Director, Clinical Trial Contracts and Budgets | Biologist (m/w/d)
BioNTech SE
Job Summary
This strategic, global, and remote leadership role requires an experienced professional to build and manage a high-performing team responsible for the full lifecycle management of clinical trial contract and budget escalations. The Director will provide strategic direction, oversight, and operational management, ensuring compliance with US and international regulations, including FDA and ICH-GCP standards. Key daily activities involve serving as the primary escalation point for complex contract negotiations, driving the development and lifecycle management of Master Clinical Trial Agreements (CTAs) and rate cards, and continuously optimizing processes for efficiency and reduced cycle times. The position is highly attractive for leaders with deep expertise in clinical research contracts and budgets who wish to drive operational excellence and support the delivery of transformative therapies within a global biotech environment.
Required Skills
Education
Bachelor’s degree in life sciences, finance, business, or related field required; advanced degree (JD, MBA, MSc, or similar) preferred.
Experience
- Minimum 12 years in clinical research
- At least 5 years in clinical trial contract and budget negotiation/management in the US pharmaceutical, biotech, or CRO environment
- Minimum 5 years of direct line management experience, including responsibility for hiring, performance management, and team development
- Demonstrated success in people development, coaching, and mentoring
Languages
Additional
- In-depth knowledge of US clinical trial regulations, contract law, and industry standards (e.g., FDA, ICH-GCP, Sunshine Act).
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