Candidate Benefit Risk Lead

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

JOB DESCRIPTION

Make your mark for patients

We are looking for a strategic, collaborative and patient-focused Benefit-Risk Lead to join our Patient Benefit-Risk and Medical Safety team. This role may be based in a U.S. hub in Raleigh, North Carolina, or Atlanta, Georgia.

About the role

You will lead end-to-end benefit-risk assessment planning for assigned assets or candidates. You will identify emerging safety concerns, evaluate factors influencing benefit-risk outcomes, and shape risk management strategies. Working across functions, you will translate evidence into clear recommendations, support governance decisions, and monitor how risk management activities affect patient outcomes.

Who you'll work with

You will work across clinical development, medical affairs, real-world evidence, product quality, patient engagement, and regulatory teams. You may lead a cross-functional Benefit Risk Team and serve as the primary contact for assigned assets or candidates, providing clear insights to internal governance and decision-making groups.

What you'll do

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

Minimum requirements

• Bachelor's degree in a relevant scientific or healthcare discipline.
• 8+ years of experience in biopharmaceutical clinical development and strategic benefit-risk assessment.

Preferred Requirements

• Master's degree, Doctor of Pharmacy, or another relevant advanced degree.
• Experience in biopharmaceutical clinical development and strategic benefit-risk assessment. Experience managing safety writing projects and multiple safety-related deliverables.
• Experience contributing to regulatory submissions and product life cycle management.
• Clear written, verbal, presentation, and stakeholder communication skills.
• Working knowledge of applicable pharmacovigilance and clinical practice requirements
• Experience developing additional pharmacovigilance and risk minimization strategies.
• Experience using patient insights or real-world data for evidence generation. Ability to lead decisions in complex, dynamic, and ambiguous environments.
• Demonstrated focus on ethical decisions, patient outcomes, and data integrity.

*This positions reasonably anticipated base salary range is $184,000-241,500 . The actual salary offered will take into account related knowledge, skills, experience and location among other factors and may fall outside the expected range.

About us

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?

At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

At UCB, we've embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless explicitly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable federal, state, or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [e-mail] for application to US based roles.

Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.