Associate Director, Structured Benefit-Risk Assessment Lead

Bristol Myers Squibb • Madison, NJ

3d

About The Position

Working with Us 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. Read more: careers.bms.com/working-with-us . Position 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.

Requirements

• 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.
• 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.

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
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees