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Program patient safety lead

Anderlecht
Publiée le 2 octobre
Description de l'offre

Make your mark for patients


We are looking for a Program Patient Safety Lead who is passionate, agile, and detail-oriented to strengthen our Early Clinical Development Benefit Risk and Medical Safety Unit team. This role can be based in one of our hubs in Braine l’Alleud, Belgium (preferred); Slough, UK; or Raleigh, US.

About the role

The Candidate Benefit Risk Lead is accountable for the strategic planning, communication, and delivery of benefit-risk assessments and risk management strategy (Benefit-risk assessment plan; BRAP) for assigned clinical-stage candidates. This includes identifying emerging safety concerns, evaluating benefit-risk outcomes, and developing effective risk management strategies.

Who you'll work with

You will work transversally with multiple UCB stakeholders (Clinical Development, Quantitative Clinical Pharmacology, Regulatory, Statistics and Non-clinical Safety amongst others) and patients to drive and implement program safety strategies. You’ll lead the cross-functional Benefit Risk Team (BRT), empowering and inspiring team members to take ownership of their responsibilities and use data-driven insights to inform decisions.

What you'll do

1. Drive the program-specific safety strategy and ensure high-quality BRAP outputs with clarity, transparency, and key messaging.
2. Implement safety monitoring and risk management strategies in collaboration with cross-functional teams.
3. Communicate insights to support decision-making at internal governance bodies (eg. EDM, PPC, BRB).
4. Analyze and interpret safety data (clinical, regulatory, legal, product quality) to identify potential new risks.
5. Author and review documents in accordance with global clinical development strategy and regulatory submission requirements.
6. Apply innovative approaches and technologies for data collection, documentation, and evidence generation.
7. Make ethical decisions aligned with UCB’s values, prioritizing patient safety and regulatory compliance.

Interested? We’re looking for:

8. MD preferred, PhD, PharmD or equivalent with relevant experience
9. Significant experience in early clinical development (first in human to proof of concept) and risk management; preferably in industry environment.
10. Experience in Phase 1 trials and/or Gene Therapy is highly preferred.
11. Strong knowledge of Good Clinical Practice and international drug safety regulations.
12. Demonstrated leadership in complex, dynamic environments with short timelines and ambiguity.
13. Cross-functional collaboration skills to ensure credible communication with the external medical and scientific community and for internal communication.
14. Excellent English communication skills—verbal, written, and presentation skills
15. Proficient and positive attitude toward using digital tools


Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

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