Senior Director, Medical Safety Assessment Program Lead, Neuroscience

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Functional Area Description

The Patient Safety (PS) group is responsible for ensuring the safety of our medicines. PS pharmacovigilance and pharmacoepidemiology deliverables include single case and aggregate safety monitoring, safety reporting, contributing to benefit-risk assessment, risk management planning and strategy, execution of certain postmarketing commitments, and ensuring compliance with global regulatory requirements.

Position Summary

• Lead safety activities and benefit-risk strategies for assigned BMS compounds/ program and chair the product Safety Management Team(s).

• Oversee, Prepare, and/or Review aggregate safety review documents as well as safety sections of relevant clinical trial documents and regulatory filings.

• Coordinate a group of Medical Safety Assessment Physicians (MSAPs) for the evaluation & management of signals emerging from any data source. Develop strategy for signal evaluation and document outcome.

• Lead safety labeling activities for assigned products/ program. Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/ Provide input at cross-functional labeling team meetings and provide regional safety labeling support.

• Lead process improvement projects. Assist the MSA Therapeutic Area (TA) Head/Lead in developing and maintaining state-of-the-art PV processes and procedures within BMS R&D and WWPS.

• Support the EU Qualified Person for Pharmacovigilance (PV) or other regional or local Qualified Person for PV relative to issues relating to assigned products.

• Provide input to R&D publication strategy/ plan & ensure safety input to publications/ presentations.

• Actively drive safety strategy preparation and Represent PS at Health Authority (HA) and Data Monitoring Committee (DMC) meetings.

• Ensure that the above tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements and BMS cost effectiveness goals.

• Promote collegiality and teamwork among peers. Mentor/Support colleagues as a positive change agent.

Position Responsibilities (in addition to above)

General product support

• Review aggregate safety review documents (eg, Development Safety Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER]) and safety sections of relevant clinical trial documents (eg, protocols, clinical study reports [CSR], investigator brochures [IB], informed consent forms [ICF]) and regulatory filings (eg, clinical trial applications [CTA], marketing authorization applications [MAA]).

• Develop strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Document by Safety Topic Review/ Signal Report or other means of communication.

Clinical Development support

• Act as the global safety lead for assigned compounds in development. Provide safety lead support for global submission document production. Review draft summary documents.

• Lead medical safety development and execution of benefit-risk management strategies for assigned products.

• Provide safety input to clinical development plans, study protocols, amendments, IB, statistical analysis plan (SAP), ICF, CSR, responses to HA or institutional review board (IRB)/ ethics committee (EC) queries.

• Lead development of safety risk language, risk management strategy, pre-filing safety activities including safety table shells, integrated safety data review, integrated safety summary document review, safety-focused publication development.

• Perform medical safety review of DSUR, annual reports, and other periodic safety submissions.

• Represent PS at HA meetings. Actively drive safety strategy preparation for pre-submission meetings, Advisory Committee meetings, Scientific Advice meetings, DMC meetings, etc.

Postmarketing Support

• Act as the safety lead for assigned marketed compounds and support global postmarketing safety activities and submissions.

• Provide medical safety, benefit-risk input and approve safety aggregate reports, product renewal submissions, postmarketing study documents and reports, responses to HA queries.

• Lead medical safety oversight of and execution of risk management strategies and RMP elements for assigned products/ program.

• Coordinate approach across multiple related assets or indications for safety signal evaluation & management. Prepare and Review reports on safety signals (ie, Safety Topic Reviews/ Signal Reports) and ad hoc regulatory responses.

• Provide postmarketing safety study guidance to other groups including epidemiology and medical affairs including but not limited to investigator-sponsored research (ISR), epidemiology studies, non-interventional safety studies.

• Ensure safety labeling adequately reflects emerging postmarketing safety profile.

Department Activities

• Lead process improvement projects. Assist the MSA TA Head/Lead in developing and maintaining state-of-the-art PV processes and procedures within BMS R&D and WWPS.

• Support preparation for regulatory inspections with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.

• Assist the team and senior management in all forms of issue management and crisis management.

• Liaise with all TA staff and maintain an effective and collaborative patient safety team.

• Support hiring, orientation, management, mentorship, and development.

Cross-Functional Activities

• Identify data gaps and Prioritize data acquisition. Provide input to strategic plans for safety differentiation of BMS products.

• Coordinate training to BMS employees on product safety profiles/issues.

• Provide input to due diligence and potential in-licensing opportunities as requested.

• Act as PS liaison for assigned products with BMS functions (Legal, BD, Operations, Marketing, etc.).

• Support manufacturing quality. Co-Author integrated health hazard assessments.

• Develop communications of safety data & interpretation to BMS and external parties, globally.

Degree/ Experience Requirements

MD/equivalent required. Postgraduate qualification in neurology or psychiatry preferred. 5+ years in PV or relevant pharmaceutical or biomedical field (eg, Medical, Clinical, Regulatory) is strongly preferred. Other relevant experiences & accomplishments considered, such as roles in clinical research, observational research & clinical practice experience.

Key Competency Requirements

• In-depth understanding of the drug development process.

• Broad knowledge of PV and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product.

• Practiced ability to leverage the range of available tools to investigate safety concerns, including the science of observational research.

• In-depth understanding of regulatory requirements for safety assessment and action.

• Strong scientific analytical reasoning skills.

• Ability to work on multiple complex projects in parallel. Excellent attention to detail.

• Behavioral competencies necessary to work and lead within a complex matrix environment.

• Excellent verbal and written communication skills.

Travel Required Infrequent travel within the US (e.g., once a year)

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview: Cambridge Crossing: $336,480 - $407,736 Madison - Giralda - NJ - US: $300,430 - $364,054 Princeton - NJ - US: $300,430 - $364,054

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: 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/

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R1601701 : Senior Director, Medical Safety Assessment Program Lead, Neuroscience