Global Patient Safety - Clinical Development Safety Leader

Eli Lilly and Company • Us, IN

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About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Purpose: The Senior Director/Executive Director, Clinical Development Safety Leader, is a senior scientific and strategic leader who shapes safety science across Lilly’s clinical development portfolio and advances the integration of safety into drug development strategy through inclusive, collaborative leadership. This role provides end-to-end accountability for the clinical development safety contribution framework, establishing scientific standards and direction for safety inputs across clinical study protocols, investigator brochures, clinical study reports, and global regulatory submissions. The Clinical Development Safety Leader delivers authoritative scientific guidance and strategic direction for safety contributions across the full drug development lifecycle—from early clinical development through approval and lifecycle management—ensuring safety science is embedded as a foundational and shared element of clinical development strategy. This role works in close partnership with Regulatory and Clinical Global Process Owners to ensure safety contributions to clinical trials align with global regulatory requirements and Lilly’s compliance policies and standards. The role builds and sustains strategic and operational relationships with colleagues within and beyond Global Patient Safety, including Regulatory, CDDA, and Design Hub. This role reports to the Associate Vice President, GPS Safety Science. Primary Responsibilities: This job description is intended to provide a general overview of the role at the time it was prepared. Responsibilities may evolve over time and may include duties not specifically described here. Individuals should consult with their supervisor regarding actual responsibilities and any additional duties associated with the role.

Requirements

• Bachelor's Degree in a science or health-related field, pharmacy, or nursing.
• 10+ years’ experience in pharmaceutical medicine, pharmacovigilance, or drug development.
• Experince with relevant global and local regulations and legislation.
• Experience in audits and inspections.

Nice To Haves

• Knowledge of medical and clinical practices and a strong understanding of medical concepts and terminology
• Experience in clinical and post-marketing safety and regulatory submission of new license applications
• Critical, strategic thinking and decision-making skills.
• Operates well across boundaries.
• Excellent written and verbal communication skills.
• Excellent interpersonal, influencing and negotiation skills.
• Excellent organization and project management skills with ability to prioritize.
• Proven ability to work effectively as a team member to manage complex initiatives across functions.
• Demonstrated track record in process improvement and implementing process excellence initiatives.

Responsibilities

• Clinical Development Safety Leadership Scientific Strategy and Business Process Ownership
• Quality Metrics, Oversight, and Continuous Improvement
• Clinical Development Safety Science Innovation
• Enterprise Leadership and External Scientific Influence
• Understanding and Supporting the EU Qualified Person for Pharmacovigilance (QPPV) Role

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level