Associate Director/Director – Risk Management Scientist Global Patient Safety

Risk Management Technical Expertise
- Provide strategic guidance to product-specific cross-functional teams on risk minimization strategies.
- Support risk management/risk minimization activities for assigned products, including development/maintenance of RMPs, ARMMs, and REMs aligned to overall product strategy.
- Facilitate product-specific results to meet quality standards and timelines.
- Provide risk minimization resources, tools, and expertise (e.g., efficiency/assessment reports and additional PV activities).
- Collaborate with other GPS functions to track/report product-specific metrics on risk minimization efficiency and compliance.
- Serve as subject matter expert for global/therapeutic-area risk management strategies; lead in product team meetings/decision forums.
- Influence lifecycle risk management decisions; guide clinical development on benefit-risk and risk management (frameworks and visualization tools).
- Lead/support regulatory interactions related to risk management (health authority meetings; responses to regulatory questions).
- Drive consistency in tracking/documenting/presenting product metrics and KPIs; maintain awareness of global regulatory guidance.
- Coordinate large cross-functional activities with affiliates, partners, and TPOs for RMPs/risk minimization implementation.
- Identify risks and develop/communicate contingency plans; support global monitoring/execution with GPS quality.
- Identify/champion optimization opportunities; manage dependencies/interdependencies across portfolio.
- Establish regular communication with GPS and business unit personnel; advise internal/external stakeholders on risk management projects.
- Collaborate on observational studies supporting risk management objectives.
- Oversee post-marketing safety/risk minimization deliverables (e.g., REMS assessment, DSURs, PBRERs/PSURs, ARMM efficiency reports).
- Serve as SME for health authority inspections/audits; ensure GPS process/quality system utilization.
- Mentor/develop junior team members.

Enterprise Leadership
- Communicate with internal/external partners to align priorities and drive decisions.
- Maintain processes/tools to communicate product-specific risk management information to senior management, governance committees, functions, business units, partners, and affiliates.
- Represent company on external working groups related to risk management and benefit-risk assessment.
- Influence policies/practices/guidance/regulations at FDA, EMA, and other agencies.
- Champion guidelines and lessons learned.

Understand and Support the EU QPPV Role
- Demonstrate understanding of the EU Qualified Person role/responsibilities and expectations; support enablement of EU QPPV legal obligations.

Minimum Qualifications
- Bachelor’s degree in a scientific/healthcare field (e.g., Pharmacy, Nursing, Life Sciences).
- 5 years clinical development experience in pharmaceutical industry.
- 2 years patient safety experience.

Preferred Qualifications
- Advanced degree or equivalent; 3+ years clinical development experience.

Application Instructions
- If you require an accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation