Risk

• Support Head of SBRA, in defining and executing the strategic vision for the benefit-risk assessment function, aligning with organizational goals and regulatory requirements.
• Lead the benefit-risk assessment process across therapeutic areas from early clinical development through late-stage and post-marketing.
• Guide, steer and mentor the cross-functional Benefit-Risk Project Team (BRPT) in structured benefit-risk assessment of products.
• Lead development of Core SBRA document and facilitate effective communication and collaboration among internal stakeholders to achieve consensus on benefit risk profile of BMS medicines.
• Lead strategic discussions on the use of qualitative and/or quantitative methods for benefit risk assessment.
• Lead the BRPT in applying structured benefit-risk assessment.
• Provide guidance on the incorporation of the patient voice and patient preference studies for products in development as appropriate.
• Serve as a subject matter expert for questions from the BRPT and other functions, regarding content, methodology, tools and processes of SBRA.
• Support the development of decision context and identification of key benefits and key risks for BMS products and documentation of the rationale.
• Keep up to date with guidance and policy produced by regulatory agencies and other critical organizations regarding methodologies for benefit-risk assessment, patient preference studies, patient-focused drug development and other relevant guidance.
• Utilize and improve standard tools that support B-R Assessment: Benefit-risk assessment frameworks, Value tree, Effects table, Others as applicable to the submission strategy.
• Monitor and evaluate the evolving regulatory landscape to ensure compliance and best practices in benefit-risk assessment.

Associate Director, Structured Benefit-Risk Assessment Lead

Senior Business Control Specialist – QC Risk Governance

Senior Director of Risk

Director, Asset Management Risk

Data Governance & Data Domain Architect, VP

VP, Operational Risk and Resilience – Risk and Enablement