Recruitment Data Policies Candidate Benefit Risk Lead
About The Position
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. 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. 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.
Requirements
- Bachelor’s degree in a relevant scientific or healthcare discipline.
- 8+ years of experience in biopharmaceutical clinical development and strategic benefit-risk assessment.
Nice To Haves
- 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.
Responsibilities
- 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.
Benefits
- Hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity.
- 40% of your time spent in the office.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
