Associate Director, Structured Benefit-Risk Assessment Lead

Associate Director, Structured Benefit-Risk Assessment Lead

BMS - Bristol-Myers Squibb

Uxbridge, United Kingdom

About the Role

We're looking for an experienced SBRA Lead to drive structured benefit-risk assessments across BMS's portfolio — from early clinical development through to post-marketing. Reporting to the Head of SBRA within Safety Evidence & Sciences, you'll be the go-to expert for benefit-risk methodology, leading cross-functional teams and shaping company-wide positions on the benefit-risk profiles of our medicines.

This role sits at the heart of cross-functional collaboration, working closely with medical safety assessment, clinical development, global regulatory, epidemiology, and beyond to deliver robust, well-evidenced benefit-risk positions.

Directly reporting to: Head of Structured Benefit-Risk Assessment

What You'll Do

Product Scientific Leadership

• Lead end-to-end benefit-risk assessments across all therapeutic areas, from early clinical development through late-stage and post-marketing
• Guide, steer, and mentor cross-functional Benefit-Risk Project Teams (BRPTs) in the application of structured benefit-risk assessment frameworks, value trees, effects tables, and other relevant tools
• Own the development of the Core SBRA document and facilitate effective communication and collaboration among internal stakeholders to achieve consensus on the benefit-risk profile of BMS medicines
• Drive strategic discussions on the use of qualitative and/or quantitative methods for benefit-risk assessment
• Champion the patient voice by providing guidance on the incorporation of patient preference studies and patient-focused drug development into the assessment process
• Serve as subject matter expert for the BRPT and wider functions on SBRA content, methodology, tools, and processes
• Continuously improve standard benefit-risk tools and frameworks in line with evolving best practices

Strategic Planning & Oversight

• Support the Head of SBRA in defining and executing the strategic vision for the benefit-risk assessment function, aligned with organizational goals and regulatory requirements
• Monitor the regulatory landscape to ensure compliance and adoption of best practices, keeping up to date with guidance from regulatory agencies and key industry organizations
• Develop and maintain procedural documents and internal training materials related to benefit-risk assessment processes
• Build and maintain relationships with internal partners and external thought leaders in the benefit-risk field
• Communicate and innovate - develop novel ways to present benefit-risk information, author publications, and represent BMS at internal and external meetings and conferences

What You'll Bring

Qualifications

• BS/BA required; advanced degree strongly preferred (MSc, PhD, PharmD or equivalent)
• 10+ years of relevant pharmaceutical, clinical, academic, or healthcare industry experience, with significant expertise in global pharmacovigilance, safety risk management, and benefit-risk assessment
• Strong knowledge of global regulatory frameworks and processes for pharmacovigilance and benefit-risk management
• Proven track record of delivering against complex programmes within a highly matrixed organization

Skills & Abilities

• Exemplary leadership skills with a proven ability to foster partnerships both within and across organizational boundaries
• Strong analytical mindset with creative problem-solving abilities — including in challenging and ambiguous situations
• Exceptional listening, communication, and stakeholder management skills
• Skilled at managing multiple priorities, adapting to shifting demands, and operating effectively under uncertainty
• Ability to handle conflict constructively, read situations quickly, and find common ground to drive resolution