Director, Patient Safety Scientist

Bristol Myers Squibb•Princeton, NJ

2d•$217,520 - $263,577•Hybrid

About The Position

The Director, Patient Safety Scientist, is a key partner and strategic advisor to Medical Safety Assessment Physician (MSAP)/Safety Management Team (SMT) Chair to characterize conditions for safe use of BMS medicines and proactively communicate safety evidence to influence decision-making for assets in development and marketed products by evaluating and mitigating risks. The Director, Patient Safety Scientist independently performs core signal detection activities and elevates program or portfolio issues impacting key SMT programs, priorities, resources, and milestones. The Director leads safety data review meetings (SDRMs) and ensures pharmacovigilance regulatory compliance.

Requirements

Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or other degree with the equivalent combination of relevant education and professional experience.
Minimum of 8 years relevant pharmacovigilance/pharmaceutical industry/drug development experience; demonstrated ability to mentor and coach others.
Demonstrated ability to develop and execute safety strategy across complex, cross-functional initiatives in drug development, pharmacovigilance, and global regulatory safety.
Deep scientific and medical expertise with the ability to synthesize complex data (clinical, nonclinical, postmarketing, literature) to inform strategic decisions and influence stakeholders.
Strong decision-making skills grounded in scientific rigor, sound judgment, and experience.
Effective matrix leader with strong organizational, facilitation, and communication skills to drive alignment and engagement across internal and external networks, and senior leaders.
Highly adaptable and resilient in dynamic environments; consistently demonstrates initiative and professionalism.
Ability to incorporate emerging technologies (including AI, automation tools, and digital platforms) to streamline workflows, enhance data analysis, and reduce manual effort, while maintaining scientific rigor and compliance with safety standards.

Responsibilities

Develops or co-develops the global safety strategy in partnership with the SMT Chair, overseeing signal detection and assessment across the product lifecycle for multiple complex compounds.
Utilizes advanced tools and diverse data sources to investigate safety concerns, enabling proactive risk management and informed decision-making.
Leads execution for signal evaluation (e.g., case-series, literature review, health authority/claims databases), promotes cross-functional collaboration with authors for comprehensive signal reports, develops clear preliminary conclusions, and ensures timely tracking, stakeholder engagement, and documentation within the signal management system.
Develops strategy and provides strong medical writing for safety and risk management sections of aggregate safety documents (e.g., DSUR, PBRER, PADER).
Develops strategy, analyzes data, and writes ad hoc responses to health authorities (including supporting local markets in responding to risk management-related queries from local HAs), and mentors less experienced scientists in this area.
Leads the preparation, review, and strategic input for safety sections in key clinical trial documents, such as protocols, clinical study reports (CSR), investigator brochures (IB) including reference safety information (RSI), informed consent forms (ICF), and contraception language.
Represents Patient Safety and supports safety strategy preparation at internal and external meetings (pre-submission, Advisory Committees, Scientific Advice, data monitoring committee, publications, etc.).
Co-develops safety strategy and input for regulatory filings, including the formulation of safety strategy, key safety messages, and risk management approaches.
Provides expert oversight and authorship of safety sections on marketing authorization applications (MAA), including safety table shells, Integrated Summary of Safety (ISS), Summary of Clinical Safety (SCS), clinical overview, briefing documents, and initial product labeling (USPI, CCDS, SmPC).
Leads cross-functional responses to ad hoc regulatory safety requests (e.g., 120-day safety updates), proactively sourcing and interpreting safety data to evaluate the impact of emerging safety issues on the product’s benefit-risk profile.
Provides expert analysis and strategic input, analyzes data, and authors documentation as needed to support safety labeling updates to adequately reflect emerging postmarketing safety profile.
Supports the EU QPPV or other regional/local QP for safety issues on assigned products.
Creates strategy for creation and update of the EDSR to proactively characterize emerging safety concerns during asset development, support Structured Benefit Risk, and define the strategy for Company Core Risk Management and gaining alignment with SMT/governance, including collaboration with Epidemiology on risk minimization effectiveness, non-interventional research (NIR) activities for post-authorization safety studies (PASS).
Provides strategic leadership and is accountable for the development and maintenance of global and EU Risk Management Plans (RMPs), including understanding of in-licensing arrangements or pharmacovigilance agreements that may impact risk management activities.
Leads and oversees the creation and revisions to core additional Risk Minimization Measures (aRMMs) and additional Pharmacovigilance Activities (aPVAs) globally and locally.
Provides guidance to local markets and vendors for complex (e.g., Pregnancy Prevention Programs, Controlled Distribution Programs) and non-complex aRMMs (e.g., educational materials).
Oversees a global team of safety scientists and risk management experts within the assigned therapeutic area.
Leverages automation and innovation tools into day-to-day work.
Drives digital change initiatives, including management of stakeholder expectations and overcoming resistance.
Uses multiple data sources and AI generated outputs to support decisions.
Supports preparation for regulatory inspections and audits as a subject matter expert through proactive evaluation of current processes; assesses alignment with regulatory expectations, guidelines, and mandates.
Fosters a high-performing and collaborative safety team by actively engaging with all TA staff, serving as a strategic partner and role model in cross-functional interactions, and promoting a culture of excellence, accountability, and continuous improvement.
Leads or identifies opportunities for process improvements and cross-functional initiatives for Patient Safety Science, including update and maintenance of procedural documents.
Builds cross-functional partnerships with SMT/ACT stakeholders, exercising strong matrix leadership to drive alignment, accountability, and timely decision-making across functions.
Possesses deep knowledge of product goals, strategy, drug development milestones, partnership agreements, HA commitments, functional area responsibilities, and relevant global HA regulations and industry trends; shares with cross-functional teams as needed.

Benefits

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
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.
flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))
160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
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
an annual Global Shutdown between Christmas and New Years Day.