Associate Director, Structured Benefit‑Risk Assessment Lead
Challenging. Meaningful. Life‑changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high‑achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Position Summary
The Structured Benefit‑Risk Assessment (SBRA) Lead reports to the Structured Benefit‑Risk Assessment Head within Safety Evidence and Sciences and is accountable for leading 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 establish the company position on the product benefit‑risk balance through the application of benefit‑risk assessment framework, tools and methodologies.
Duties / Responsibilities
* 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 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.
* 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).
* 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 a complex program plan.
Specific Knowledge, Skills & 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
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 employee’s 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 by job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit Offerings
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include Medical, pharmacy, dental and vision care; wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP); financial well‑being resources and a 401(k); financial protection benefits such as short‑ and long‑term disability, life insurance, supplemental health insurance, business travel protection and survivor support; work‑life programs including paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off and summer hours 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; and other perks like tuition reimbursement and a recognition program.
Equal Employment Opportunity Statement
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 https://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 for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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