Associate Director, Structured Benefit‑Risk Assessment Lead
Join to apply for the Associate Director, Structured Benefit‑Risk Assessment Lead role at Bristol Myers Squibb. The Structured Benefit‑Risk Assessment (SBRA) Lead will report to the Structured Benefit‑Risk Assessment Head within Safety Evidence and Sciences and will be accountable for leading structured benefit‑risk assessments for assigned assets from early clinical development through late‑stage and post‑marketing.
Position Summary
The SBRA Lead will drive functional alignment on key benefits and risks of BMS assets, establish the company position on product benefit‑risk balance, and apply benefit‑risk assessment frameworks and methodologies. The role requires close cross‑functional collaboration with medical safety assessment, clinical development, global regulatory, epidemiology, and other departments.
Duties/Responsibilities
Product Scientific Support
- Support the 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 the Core SBRA document and facilitate effective communication and collaboration among internal stakeholders to achieve consensus on the 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 organizations regarding methodologies for benefit‑risk assessment, patient preference studies, patient‑focused drug development and related 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 the definition of 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 plans.
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.
Compensation Overview
- Madison – Giralda – NJ – US: $150,300 – $182,125
- Princeton – NJ – US: $150,300 – $182,125
- Additional incentive cash and stock opportunities (based on eligibility) may be available.
- Eligibility for specific benefits may vary by job and location.
- Benefit offerings include medical, pharmacy, dental and vision care; wellbeing support (BMS Living Life Better program, EAP); financial well‑being resources and 401(K); short‑ and long‑term disability, life insurance, supplemental health insurance, business travel protection and survivor support; work‑life programs such as paid national holidays, optional holidays, Global Shutdown Days, up to 120 hours of paid vacation, volunteer days, sick time off and summer hour flexibility; parental, caregiver, bereavement and military leave; family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources; tuition reimbursement and a recognition program.
Uniquely Interesting Work, Life‑changing Careers
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
Occupancy structure determines where an employee is required to conduct their work. 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.
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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well‑being and the well‑being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid‑19 and keep up to date with Covid‑19 boosters.
BMS will consider 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: https://careers.bms.com/california-residents/.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.