Associate Director, Structured Benefit-Risk Assessment Lead

Role Summary

The Structured Benefit-Risk Assessment (SBRA) Lead will report into the Structured Benefit-Risk Assessment Head within Safety Evidence and Sciences and will be accountable to lead structured benefit-risk assessments for assigned assets from early clinical development through late-stage and post-marketing. This role requires close cross-functional collaboration with relevant departments across the organization, including medical safety assessment, clinical development, global regulatory, epidemiology and others. The SBRA Lead will drive functional alignment on key benefits and risks of BMS assets and establishment of company position on the product benefit risk balance through the application of benefit-risk assessment framework, tools and methodologies.

Responsibilities

• 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

Strategic Planning and Oversight

• Support in defining the strategic vision for the benefit-risk assessment function, aligning with organizational goals and regulatory requirements.
• Monitor and evaluate the evolving regulatory landscape to ensure compliance and best practices in benefit-risk assessment.
• Establish, cultivate, and maintain external relationships with key partners within BMS and thought leaders.
• Assist with internal benefit-risk process development and training.
• Develop and maintain applicable procedural documents related to benefit-risk assessment.
• Develop novel means to communicate and display benefit-risk information, participate in external benefit-risk methodology and policy activities, author publications on the research and present at internal/external meetings.

Qualifications

• BS/BA required, advanced scientific degree preferred (Masters, PhD, PharmD etc.).
• Minimum of 10 years of relevant pharmaceutical industry, clinical, academic or relevant healthcare industry experience, with significant experience in global pharmaceutical safety risk management and benefit-risk management.
• Strong knowledge of processes and global regulations for pharmacovigilance and benefit-risk management.
• Demonstrated success in navigating a highly matrix-based organization to deliver against complex program plan.

Skills

• Exemplary leadership skills with proven ability to foster partnerships within a functional area and across organizational boundaries.
• Demonstrated problem-solving skills, including in challenging and ambiguous situations.
• Creative thinker with exceptional listening and analytical skills.
• Skilled at being adaptable/flexible and managing multiple demands and shifting priorities.
• Effective time management and comfortable handling risk and uncertainty.
• Ability to work effectively independently and manage multiple priorities.
• Ability to handle conflict, read situations quickly, and find common ground for achieving cooperation and resolution.

Travel

• Travel up to 5-10% of time.