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Program Patient Safety Lead

UCBRaleigh, NC

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Job Description

Make your mark for patients

We are looking for a Candidate Benefit Risk 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

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

Interested? We're looking for:

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

This role is part of 2026 recruitments pending approvals soon.

Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com . Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

Requisition ID: 91418

Recruiter: Laure Urbain

Hiring Manager: Daniel Stiehl

Talent Partner: Mihaela Pascaru

Job Level: MM I - SM II

Please consult HRAnswers for more information on job levels.

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