Senior Benefit-Risk Lead, Patient Safety Strategy

UCB Inc.; Raleigh (NC); Hybrid; USD 184,000 - 242,000; Full time

Job summary

UCB Inc. is seeking a strategic Benefit-Risk Lead to guide end-to-end assessment planning for assets and candidates. You will identify safety risks, integrate diverse evidence, and shape risk management across development programs.

You will work across clinical development, medical safety, and regulatory teams, leading cross-functional risk decisions and contributing to global submissions. This hybrid role is based in the U.S. hub with focus on patient outcomes and data integrity.

Qualifications

• Bachelor's degree in a relevant scientific or healthcare discipline.
• 8+ years of experience in biopharmaceutical clinical development and strategic benefit-risk assessment.
• Experience contributing to regulatory submissions and product life cycle management.
• Experience managing safety writing projects and multiple safety-related deliverables.
• Clear written, verbal, presentation, and stakeholder communication skills.
• Working knowledge of pharmacovigilance and clinical practice requirements.
• Experience developing pharmacovigilance and risk minimization strategies.
• Experience using patient insights or real-world data for evidence generation.

Responsibilities

• Lead end-to-end benefit-risk assessment planning for assets and candidates.
• Analyze evidence to identify emerging safety risks.
• Integrate clinical, post-marketing, quality, patient, and real-world evidence.
• Shape safety monitoring and risk management strategies across programs.
• Author and approve documents for global regulatory submissions.
• Coordinate cross-functional delivery with regulatory, process, and quality compliance.

Skills

Benefit-risk assessment

Regulatory submissions

Cross-functional collaboration

Stakeholder communication

Pharmacovigilance

Risk management

Clinical development

Education

Bachelor's degree in a scientific/healthcare field

Master's degree or Doctor of Pharmacy (preferred)

Job description

UCB Inc. is seeking a strategic Benefit-Risk Lead to guide end-to-end assessment planning for assets and candidates. You will identify safety risks, integrate diverse evidence, and shape risk management across development programs.

You will work across clinical development, medical safety, and regulatory teams, leading cross-functional risk decisions and contributing to global submissions. This hybrid role is based in the U.S. hub with focus on patient outcomes and data integrity.