Associate Director/Director – Risk Management Scientist Global Patient Safety

Risk Management Technical Expertise
- Provide strategic guidance to product-specific cross-functional teams on optimal risk minimization strategies
- Support risk management and risk minimization activities for assigned products, including development and maintenance of RMPs, ARMMs, and REMs in alignment with overall product strategy
- Facilitate product-specific results to meet quality standards and timelines
- Provide risk minimization resources, tools, and expertise for the assigned product portfolio (including risk minimization efficiency/assessment reports and additional PV activities)
- Collaborate with other GPS functions to track and report product-specific metrics related to risk minimization efficiency and compliance
- Lead as subject matter expert for Risk Management strategies across therapeutic areas globally in collaboration with cross-functional teams; participate in key product team meetings and decision forums
- Influence product teams’ strategic decisions on risk management approaches throughout the product lifecycle
- Guide clinical development teams on benefit-risk and risk management considerations during product development (including benefit-risk assessment frameworks and visualization tools)
- Lead and support product-specific regulatory interactions related to risk management (e.g., health authority meetings, responses to regulatory questions)
- Drive consistency in tracking, documenting, and presenting product-specific metrics and key performance indicators
- Maintain awareness of the global regulatory environment and new guidance impacting product risk management activities
- Coordinate large, multi-component, cross-functional product-specific activities with affiliates, partners, and TPOs for RMP and risk minimization design/implementation
- Proactively identify risks to product-specific risk management activities and develop/communicate contingency plans to key collaborators
- Support global monitoring and tracking of implementation/execution of product-specific Risk Management activities with the GPS quality group
- Identify and champion opportunities to optimize risk management strategy based on accumulating product data
- Identify and communicate dependencies and interdependencies across the assigned product portfolio
- Establish and maintain regular communication with key GPS and business unit personnel
- Advise and guide product-specific risk management activities with internal cross-functional customers (medical affairs, regulatory, clinical development, commercial, regional/local affiliates) and external TPOs
- Collaborate with GPS pharmacoepidemiology on observational studies supporting risk management objectives
- Collaborate with other GPS functions on oversight of post-marketing safety activities (risk minimization efficiency reports, REMS assessment reports, DSURs, PBRERs/PSURs, ARMM efficiency reports)
- Serve as SME for Health Authority inspections and audits within scope of risk management
- Ensure utilization and consistency of detailed GPS processes and quality systems
- Mentor and develop junior team members on technical and regulatory aspects of risk management and risk minimization

Enterprise Leadership
- Communicate effectively with internal and external partners to align priorities and drive informed decision-making
- Support and maintain processes and tools to communicate product-specific risk management information to key partners (senior management, governance committees, product team members, functions, business units, partners, affiliates)
- Represent the company on selected external working groups related to risk management and benefit-risk assessment
- Influence the development of initiatives (policies, practices, guidance, regulations) at FDA, EMA, and other regulatory agencies
- Champion guidelines and lessons learned from product experience to improve organizational capabilities

Understand and Support the EU QPPV Role
- Demonstrate understanding of EU Qualified Person roles/responsibilities and regulatory expectations
- Support the EU Qualified Person in fulfilling legal obligations

Minimum Qualifications
- Bachelor’s degree in a scientific or healthcare related field (e.g., Pharmacy, Nursing, Life Sciences)
- 5 years of experience in Clinical Development in scientific/healthcare for the pharmaceutical industry
- 2 years of experience in patient safety

Preferred Qualifications
- Advanced degree or equivalent strongly preferred
- 3+ years experience in Clinical Development in scientific/healthcare for the pharmaceutical industry

Benefits (as explicitly stated)
- Eligibility for a company bonus (depending, in part, on company and individual performance)
- Eligibility to participate in a company-sponsored 401(k); pension; vacation benefits
- Medical, dental, vision and prescription drug benefits
- Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- Life insurance and death benefits
- Certain time off and leave of absence benefits
- Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

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