Sr. Director - PV Project Management (PV PM) Global Patient Safety

Senior Director, Pharmacovigilance Project Management (PV PM)

Primary Responsibilities
- Drive development and execution of the GPS PMO strategic roadmap; align portfolio initiatives with enterprise objectives, regulatory requirements, and organizational priorities.
- Lead enterprise-level portfolio management (investment planning, prioritization frameworks, capacity planning, performance analytics) to optimize resource allocation.
- Support the drug portfolio review process aligned to global development priorities, risk management strategies, and patient safety objectives.
- Establish and maintain portfolio governance frameworks, decision-making processes, and performance metrics.
- Partner with GPS senior leadership to identify strategic opportunities and capability gaps.
- Lead IDEA intake assessment and decision processes, managing resource allocation, portfolio balancing, and PMO book of work.
- Develop and implement enterprise risk management frameworks for the GPS portfolio (identification, assessment, mitigation, monitoring).
- Support third-party strategy (vendor selection, risk-based qualification, performance monitoring, compliance assurance).
- Implement risk-based oversight models for external partnerships.
- Lead cross-functional risk assessment reviews and advance issues to governance bodies with recommendations.
- Ensure audit and inspection readiness across the portfolio.
- Handle portfolio execution (scope, timeline, budget, quality); manage dependencies and raise issues to governance.
- Develop resource modeling/forecasting tools to optimize capacity planning and utilization.
- Monitor portfolio health metrics and provide executive reporting.
- Drive process standardization and optimization across the PMO.
- Lead development of PMO capabilities (tools, templates, training, knowledge management).
- Support portfolio governance cadence (steering committees, leadership reviews, communications).
- Lead GPS change initiatives (process redesign, technology adoption, restructuring, cultural transformation).
- Design/implement OCM strategies (partner analysis, communications, training, adoption metrics).
- Serve as change champion/executive sponsor; coach leaders and teams; build change capability.
- Develop change readiness, resistance management, sustainability plans.
- Partner with Learning & Development and Quality Assurance to align change initiatives.
- Establish structural transformation frameworks, toolkits, and metrics.
- Build and lead a high-performing PMO team; define roles and performance expectations.
- Mentor/coaching for project managers and PMO team members.
- Develop talent pipeline (recruitment, onboarding, capability assessments, succession planning).
- Foster continuous learning, innovation, collaboration (knowledge sharing, communities of practice, recognition).
- Demonstrate Team Lilly behaviors (Include, Innovate, Accelerate, Deliver).
- Conduct performance management (goal setting, feedback, development planning, recognition).
- Lead cross-functional/matrixed teams through influence without direct authority.
- Design and implement process-improvement frameworks (process mapping, value-stream analysis, lean, automation opportunities).
- Simplify processes (identify inefficiencies, reduce duplication, standardize practices).
- Facilitate retrospectives/after-action analyses to drive learning.
- Establish global training compliance frameworks (governance, audit readiness, metrics).
- Collaborate with Quality Assurance and Regulatory Affairs for continuous improvement and inspection readiness.
- Champion knowledge management/shared learning (repositories, forums, collaboration platforms).

Minimum Qualifications
- Bachelor’s degree in life sciences, business, project management, or related field.
- 6+ years of project/program management experience in pharmaceutical/biotechnology/healthcare.
- 5+ years in senior leadership roles with direct people management responsibility.
- Experience leading enterprise-level portfolio management, program, and organizational transformation initiatives.

Preferred Qualifications/Skills
- Advanced degree (MBA, MS, or Master’s in Project Management) strongly preferred.
- PMP and/or ProSci certifications preferred; Portfolio Management/Agile highly valued.
- Cross-functional leadership success in matrixed environments; influence senior executives without direct authority.
- Self-management and organizational skills; ability to manage competing priorities.
- Proficiency with project management tools (MS Project, Smartsheet, JIRA, portfolio management software).
- Experience in pharmacovigilance, drug safety, or regulatory affairs; knowledge of global safety requirements and ICH guidelines.
- Experience implementing organizational change methodologies (Prosci, ADKAR, Kotter).
- Expertise in risk management frameworks; vendor management and third-party oversight in regulated environments.
- Experience with process mapping and improvement methods (Lean, Six Sigma).
- Experience with capacity planning/resource models and predictive analytics.
- Exceptional executive communication (presentation, facilitation, negotiation, executive reporting).
- Strong business insight (financial management, budget oversight, ROI/value realization).
- Knowledge of quality system requirements, regulatory compliance, and audit/inspection preparation.

Benefits (if applicable)
- Full-time employees may be eligible for a company bonus (depending on company and individual performance).
- Comprehensive benefits include 401(k), pension, vacation, medical/dental/vision/prescription benefits, flexible benefits, life insurance/death benefits, time off/leave of absence benefits, and well-being benefits (EAP, fitness benefits, employee clubs/activities).

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