Associate Director, Structured Benefit-Risk Assessment Lead

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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 assessmentsfor 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.

Duties/Responsibilities

Product Scientific Support

• 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.

Reporting Relationship: The SBRA Lead reports to the Head of Structured Benefit-Risk Assessment

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.

Specific Knowledge Skills and Abilities

• 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: This position requires up to 5-10% of travel.

If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical pharmacy dental and vision care.

• Wellbeing Support: Programs such as BMS Well-Being Account BMS Living Life Better and Employee Assistance Programs (EAP).

• Financial Well-being and Protection: 401(k) plan short- and long-term disability life insurance accident insurance supplemental health insurance business travel protection personal liability protection identity theft benefit legal support and survivor support.

Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited with manager approval 11 paid national holidays (not applicable to employees in Phoenix AZ Puerto Rico or Rayzebio employees)

• Phoenix AZ Puerto Rico and Rayzebio Exempt Non-Exempt Hourly Employees: 160 hours annual paid vacation for new hires with manager approval 11 national holidays and 3 optional holidays

Based on eligibility* additional time off for employees may include unlimited paid sick time up to 2 paid volunteer days per year summer hours flexibility leaves of absence for medical personal parental caregiver bereavement and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours depending on the nature of their work and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors leased workers and other service providers are not eligible to participate in the program.

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With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: Protection

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