Associate Director, Structured Benefit‑Risk Assessment Lead
Join to apply for the Associate Director, Structured Benefit‑Risk Assessment Lead role at Bristol Myers Squibb.
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. The role requires close cross‑functional collaboration with medical safety assessment, clinical development, global regulatory, epidemiology and other departments. The SBRA Lead drives functional alignment on key benefits and risks of BMS assets and establishes the company position on the product benefit‑risk balance using benefit‑risk assessment frameworks, 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 documents 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 incorporating 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 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 SBRA, such as benefit‑risk assessment frameworks, value trees, effects tables and other applicable submission‑strategy tools.
* 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, training, and procedural documentation.
* Develop novel means to communicate and display benefit‑risk information, participate in external benefit‑risk methodology and policy activities, those 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 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% travel.
Compensation Overview
Salary range (e.g., Madison – Giralda – NJ – US and Princeton – NJ – US): $150,300 – $182,125. Additional incentive cash and stock opportunities may be available based on eligibility.
Benefits
Benefit offerings 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; 401(k) and other retirement plans; disability and life insurance; travel protection; paid national holidays, optional holidays, global shutdown days, up to 120 hours paid vacation, volunteer days, sick time, 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, child, elder and pet care resources; tuition reimbursement and recognition programs.
Equal Opportunity & Accessibility
BMS is committed to a transparent recruitment process and to providing reasonable accommodations for people with disabilities. For accessibility information, visit careers.bms.com/eeo‑accessibility. BMS will consider qualified applicants with arrest and conviction records pursuant to applicable laws.
Health & Safety
BMS strongly recommends that all employees be fully vaccinated for Covid‑19 and keep up‑to‑date with Covid‑19 boosters.
Legal Statements
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
#J-18808-Ljbffr