Sr. Director - GPS Case Management Clinical & Commercial Liaison

Eli Lilly and Company • Indianapolis, IN

2d

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 purpose of the Sr. Director - Global Patient Safety Clinical and Commercial Liaison is accountable for development of Case Management strategy and standards for safety-related organized data collection in Lilly clinical trials and commercial activities (e.g., patient support programs and market research) in compliance with global regulatory requirements and Lilly compliance policies and standards. This role oversees the Case Management Operations safety data collection strategy across clinical trial and commercial programs and engage in cross-functional activities to ensure and promote compliance with pharmacovigilance data collection standards and operational consistency across clinical trials and commercial programs for all Lilly products. This role ensures effective collaboration between Global Patient Safety (GPS) and clinical development teams, commercial operations, call centers, market research programs, and patient support initiatives working in close collaboration with internal GPS leaders responsible as well as commercial and clinical functional leaders and external business partners. This role reports to the Associate Vice President / Vice President of Case Management. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any role/position can change over time and can include additional responsibilities not specifically described in the job description. Consult with your supervisor regarding your actual job responsibilities and any related duties that might be required for the role/position.

Requirements

• Bachelor's degree within a science field
• 10+ years’ experience, in Pharmacovigilance or interconnected areas (e.g., Medical Affairs, Drug Safety Quality, Clinical, etc.)
• 3+ years experience with people managementnt
• Experience working in a multicultural virtual global environment
• Experience in clinical studies and health scientific data
• Experience in leading teams

Nice To Haves

• Experience in both clinical development and commercial pharmacovigilance settings
• Knowledge of global pharmacovigilance regulations (FDA, EMA, ICH guidelines)
• Understanding of Good Pharmacovigilance Practices (GVP) and Good Clinical Practices (GCP)
• Experience with call center operations and customer-facing programs
• Strong relationship management and influencing skills
• Experience training and supporting cross-functional teams
• Demonstrated leadership, emotional intelligence and management skills
• Background in clinical trial safety reporting and commercial operations
• Excellent communication (written and verbal), interpersonal, organizational, and negotiation skills

Responsibilities

• Develop and implement strategic plans for standardization of adverse event collection across all clinical trials and commercial programs, ensuring consistent pharmacovigilance data standards and appropriate scientific expertise aligned to current and future product portfolios.
• Lead initiatives to standardize AE collection procedures, innovate technology for improved data capture and quality, and benchmark against industry standards.
• Collaborate cross-functionally with the Clinical Development and Commercial Teams, Case Management Operations, GPS Medical Review, Safety Science, Regulatory Affairs, Legal, Compliance, and Tech@Lilly/PV Data and Systems to ensure seamless AE handoff, address safety concerns, optimize systems, and align on regulatory and contractual requirements.
• Advance concerns arising from clinical trials, developmental programs, and commercial programs in accordance with SOPs; contribute to drug safety documents including SAE reporting plans, IND/EU annual reports, and periodic reports as needed.
• Support business planning for new product launches, internal and external inspections, and GPS Case Management strategic planning—representing Clinical & Commercial Liaison capabilities and resource needs.
• Identify resource requirements and handle budget for liaison activities and external training programs.
• Support internal and external regulatory inspections and audits through direct involvement, resource coordination, document preparation, and subject matter expertise.
• Responsible for developing strong cross functional relationships to ensure and promote compliance with data collection standards, analysis, reporting standards and operational consistency across interventional, non-interventional trials and commercial programs for all Lilly products.
• Accountable for ensuring creation and dissemination of appropriate safety reporting language in commercial and clinical trial key documents.
• Ensures preparation of the safety contents for regulatory requests, Data Monitoring Committees reports and requests, IB, CRF’s other submissions, and provides the essential quality control.
• Lead all aspects of interactions with The Lilly Answers Center (TLAC) and other call centers to ensure compliant adverse event capture and reporting.
• Provide strategic direction for adverse event training programs for call center staff.
• Establish and observe quality metrics for AE data collection from customer-facing channels.
• Serve as primary GPS liaison for medical information teams regarding adverse event reporting processes.
• Coordinate responses to complex adverse event inquiries raised from call centers.
• Oversee interactions with Lilly Market Research teams to ensure input and consultation on program design from a pharmacovigilance perspective on the appropriate collection of adverse events from market research activities.
• Prompt reconciliation of AEs identified through market research programs.
• Compliance with regulatory requirements for AE reporting from market research.
• Provide pharmacovigilance training and guidance to commercial program teams.
• Ensure contractual agreements with third-party vendors include appropriate AE reporting provisions.
• Partner with Clinical Development teams to ensure alignment on adverse event reporting requirements for clinical trials, protocol safety reporting procedures, investigator training on AE reporting, clinical trial safety data transfer to safety databases.
• Serve as primary GPS liaison for clinical operations regarding safety reporting processes.
• Support clinical teams with safety-related questions during protocol development and study execution.
• Oversee GPS input into clinical trial agreements regarding safety data exchange.
• Collaborate on clinical trial inspection readiness from a safety reporting perspective.
• Recruit, develop, and retain a scientific and operationally capable workforce skilled and knowledgeable in pharmacovigilance and the drug development lifecycle.
• Effectively create and manage an agile organization that continuously meets the needs of a changing portfolio
• Build an organizational culture that fosters inclusion and innovation.
• Develop staff who demonstrate expertise in drug development, therapeutic area science, and cross-functional leadership.
• Develop an organizational talent base that demonstrates judgment-based decision making and provides leadership in medical review capabilities.
• Ensure organizational compliance with relevant Lilly SOP's, compliance with relevant global or local regulations and organizational compliance with training requirements.
• Understand and Support of the EU QPPV role Understanding the roles and responsibilities of the EU Qualified Person.
• Ensure support is provided to enable the Qualified Person to fulfill all the Qualified Person legal 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).

What This Job Offers

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