Global Patient Safety - Clinical Development Safety Leader

Lilly•Indianapolis, IN

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. Core responsibilities may include those listed below, as determined by line management, along with other assigned duties.

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
Provides authoritative and inclusive scientific leadership and strategic direction for safety contributions across the full drug development lifecycle, from first-in-human through approval and lifecycle management, ensuring safety science is embedded as a foundational element of clinical development strategy.
Owns and continuously improves end-to-end processes for clinical development safety contributions to clinical study protocols, investigator brochures, clinical study reports, and regulatory submissions (IND, NDA/BLA, MAAs).
Establishes and maintains standards, templates, and protocols that reflect innovative safety science, meet global regulatory requirements, and ensure scientific rigor, quality, and interpretability of safety data.
Serves as a primary scientific authority and strategic partner for safety across clinical operations, regulatory affairs, medical affairs, and pharmacovigilance, shaping how safety evidence is collaboratively generated, interpreted, and communicated to support informed drug development decisions.
Provides scientific leadership to clinical teams on the design of safety-optimized study protocols, guiding safety monitoring strategies, informed consent language, and data collection approaches to support robust and actionable safety insights.
Partners with biostatistics and data management colleagues to advance innovation in safety data analysis, visualization, and communication, ensuring safety findings are scientifically sound and clearly conveyed to health authorities and clinical decision-makers.
Monitors the evolving global regulatory landscape for clinical development safety through systematic horizon scanning and impact assessment, anticipating change and positioning Lilly proactively.
Drives enterprise-wide alignment on clinical development safety standards, contributing vision and leadership to how safety is approached across therapeutic areas and modalities, including small molecules, biologics, and emerging platforms.
Serves as a subject matter expert for clinical development safety during inspections and audits, supporting inspection readiness, representing Lilly’s scientific positions with regulators, and contributing to scientifically robust responses to regulatory observations.
Quality Metrics, Oversight, and Continuous Improvement
Defines and maintains a comprehensive performance measurement framework for clinical development safety outputs, establishing meaningful quality and performance indicators to support continuous improvement.
Translates performance data into actionable insights using metrics and trend analysis to inform evidence-based decisions and advise GPS leadership on the effectiveness and trajectory of clinical development safety contributions.
Promotes a forward-looking culture of continuous improvement that anticipates regulatory evolution and advances in industry practice.
Drives strategic efficiency and scalability across clinical development safety operations by identifying opportunities to streamline workflows, reduce low-value activity, and focus effort on high-impact scientific work.
Translates global process improvement priorities into practical action, providing scientific guidance to global teams and local PV affiliates to support consistent application of standards across the organization.
Leads business input to deviations, trend analyses, impact assessments, root cause analyses, CAPA development, implementation, and with Global Medicines Quality.
Clinical Development Safety Science Innovation
Provides scientific and strategic leadership to advance clinical development safety through digital enablement, advanced analytics, and operational innovation that strengthens and accelerates drug development decision-making.
Drives innovation in safety science methodologies, including the responsible application of artificial intelligence and machine learning to clinical safety data, integration of real-world evidence, advanced visualization techniques, and novel approaches to adverse event analysis and signal characterization.
Partners with Tech@Lilly, compliance, and quality colleagues to co-develop scalable, fit-for-purpose safety science tools and digital solutions, contributing scientific expertise to technology investment decisions affecting clinical development safety.
Demonstrates deep pharmacovigilance expertise and knowledge of internal and external requirements, industry guidelines, benchmarks, emerging capabilities, and technological advances to influence operational strategy and process design in support of pharmacovigilance objectives.
Leads the collaborative identification, scientific evaluation, and strategic prioritization of technologies and analytical tools to enhance clinical development safety surveillance, data integration, and reporting, building a compelling investment case and supporting adoption across GPS and clinical development teams.
Drives scientific coherence and integration across GPS Safety Science, ensuring clinical development safety, benefit-risk management, signal management, and periodic aggregate safety reporting operate as an integrated scientific ecosystem with shared insights and a unified safety narrative.
Maintains an up-to-date and forward-looking understanding of safety science, regulatory guidance, and industry practice through engagement with scientific literature, external expert networks, and regulatory intelligence, translating insights into continuous improvement.
Enterprise Leadership and External Scientific Influence
Applies scientific expertise with sound judgment and strategic agility, operating effectively at the intersection of safety science, drug development strategy, and organizational leadership in sophisticated and evolving environments.
Represents Clinical Development Safety process contributions in relevant internal and external forums.
Contributes to shaping the external environment through participation and leadership in industry organizations, scientific working groups, and regulatory advisory bodies, advocating for patient-focused and scientifically robust clinical development safety standards.
Ensures activities are conducted in accordance with established guidelines, procedures, and all applicable laws and regulations.
Cultivates a culture of scientific curiosity, collaboration, and continuous professional development across GPS, serving as a mentor and role model who supports growth, inclusion, and scientific excellence.
Leads the development of Lilly’s scientific and policy positions on evolving global regulations, guidelines, and industry standards related to clinical development safety and pharmacovigilance, coordinating input across GPS and senior leadership and ensuring timely, high-quality submissions.
Understanding and Supporting the EU Qualified Person for Pharmacovigilance (QPPV) Role
Demonstrates understanding of the roles and responsibilities of the EU QPPV.
Ensures appropriate support is in place to enable the QPPV to fulfill all legal and regulatory responsibilities.

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).

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