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 Senior Director - Benefit-Risk Management Group Leader is to lead the development and implementation of benefit-risk strategies across our portfolio of innovative medicines and for the development and maintenance of consistent standards, competencies, capabilities, and processes required for developing and completing risk management plans and risk minimization activities globally. This role plays a critical role in ensuring the safety and efficacy of our products while also maximizing their value to patients. The role will provide strategic leadership for the effective design, development, and implementation of operating policies and procedures for maintaining and managing Lilly’s end-to-end benefit-risk management processes and associated metrics throughout the product lifecycle. This role will also spearhead the redesign and future-state advancement of benefit-risk management science defining and driving the strategic roadmap for process transformation, digital enablement, and operational excellence.
Key responsibilities include oversight of the GPS Benefit-Risk Management group, providing strategic leadership for Safety Science related activities and representing benefit-risk management and Safety Science on cross-functional teams. This role is accountable for establishing and maintaining benefit-risk management procedures, tools, and templates that will meet external regulatory requirements and Lilly standards across the product life cycle. This is accomplished through a strong working knowledge and understanding of regulations, guidelines, and regulatory precedence.
The Senior Director will ensure that the Benefit-Risk Management group maintains compliance with current regulations, ensuring efficient implementation of signal management activities through monitoring key performance indicators, and supporting continuous improvement of the team. This role will ensure that appropriate benefit-risk management resources are allocated for all Lilly products, and in support of the European Union Qualified Person for Pharmacovigilance (EU QPPV).
Benefit-Risk Management Leadership
1) End-to-End Business Process Ownership
Acts as business process owner for global end to end processes, tools, and templates for Benefit-Risk Management, Risk Management and Risk Minimization. Establishes clear Benefit-Risk Management processes, including inputs, outputs, dependencies, and accountability, partnering with stakeholders to design efficient and compliant processes.
Serves as an internal expert to provide specialized knowledge within the area of Pharmacovigilance risk management and risk minimization activities.
Collaborate with cross-functional teams to integrate benefit-risk management into the drug development process.
Lead the development and implementation of risk minimization and mitigation strategies.
Ensure committees and processes adhere to guidance, regulations, and internal procedures.
Drives scalable risk management systems partnering with stakeholders to ensure innovation and execution.
Leads cross-functional teams in process improvement activities, including documentation and personnel qualification.
Develops and maintains benefit-risk management training in collaboration with Learning & Development.
Establishes key performance measures and compliance metrics for signal detection and management tasks.
Continuous Improvement: Manages the continuous improvement agenda, ensuring compliance with evolving regulations and industry standards.
Partner with GPS Medical Therapeutic Areas and the Business Unit and Therapeutic area Medical teams to provide proactive strategic and scientific input for pharmacovigilance activities across the product lifecycle—from clinical development to post-marketing focused on Benefit-Risk and Risk Management, contributing to proactive safety strategies and regulatory compliance on a global scale.
Partner closely with other Global Patient Safety, Regulatory, Development and administrative functions to effectively plan, forecast, and manage the resources required to deliver all sanctioned projects.
Drive efficiency and continuous improvement in the Global Patient Safety organization and, as appropriate, cross-functionally to support deliverables.
Maintain current knowledge of pharmacovigilance science, standards, and procedures; monitor externally for emerging global regulations to assist in the development of future surveillance strategy.
Monitors the external environment and conducts gap assessments related to Benefit-Risk Management processes and activities ensuring compliance with regulations and regulatory authority and inspectors’ expectations.
Ensure that appropriate metrics and systems are in place to monitor quality and compliance activities globally.
Monitor metrics and ensure effective implementation of appropriate action plans by liaising with other stakeholders as appropriate to address compliance and quality issues.
Be representative for Health Authority Inspections and Internal Process Audits within the remit of role and responsibility.
Participates in safety inspections and audits, including support and coordination of required responses and the business approval of responses.
Provide governance, lead the implementation of improvement initiatives, and foster a robust compliance mindset.
Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement.
Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics.
Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools.
Actively collaborate with enterprise-wide teams on standardized global business processes.
As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed.
Actively engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to
2) Quality Metrics and Oversight
Establishes key performance measures and compliance metrics for benefit-risk management tasks.
Monitor performance metrics, report and provide insights to inform decision making to drive further improvements.
Manages the continuous improvement agenda, ensuring compliance with evolving regulations and industry standards.
Drive efficiency in the Global Patient Safety organization and, as appropriate, cross-functionally to support deliverables.
Take actions based on the above to address process improvement efforts both globally and advise local PV.
Lead business input to deviations, trending, impact assessments, root cause analysis, CAPA development implementation and effectiveness check in partnership with Global Medicines Quality.
Monitors the external environment and conducts gap assessments related to benefit-risk management processes and activities ensuring compliance with regulations and regulatory authority and inspectors’ expectations.
3) Benefit-Risk Science Innovation
Define and drive the strategic roadmap for the process, identifying opportunities for transformation, digital enablement, and operational excellence.
Develop the end-to-end process maps across functions from global to affiliate.
Collaborate with compliance, quality, and Tech at Lilly to ensure the process is fit-for-purpose, scalable and adaptable to future needs.
Drives the delivery of innovative business solutions to ensure that systems can scale to process.
Leverages pharmacovigilance expertise, knowledge of internal and external requirements, industry best practices and benchmarks, new capabilities, and advances in technology, including information flow, to influence operational strategy and design processes that meet overall signal management pharmacovigilance objectives.
Maintain current knowledge of pharmacovigilance science, standards, and procedures; monitor externally for emerging global regulations to assist in the development of future surveillance strategy.
Identify and evaluate software and tools to enhance signal management processes.
Collaborate with relevant teams to design and implement these solutions, ensuring they align with business objectives and improve operational efficiency.
Provide strategic leadership and oversight to ensure alignment and integration between benefit-risk management and other core safety science functions, including clinical development safety, periodic aggregate safety reporting and signal management, driving a cohesive and forward-looking pharmacovigilance strategy across the organization.
4) Enterprise Leadership Internal and External
Exhibit strong business acumen, strong problem-solving skills and agility to adjust to changing business priorities and needs.
Represent Benefit-Risk Management at appropriate internal and external venues.
Ensure that activities are performed according to established guidelines, best practices, and in compliance with all laws and regulations.
Drive continuous improvement of key performance metrics.
Drive shared learning and process expertise between teams within the organization.
Lead the development of Lilly positions on evolving external regulations and guidelines related to pharmacovigilance and through active engagement with relevant Lilly leadership.
5) Benefit-Risk Team Creation and Implementation
Recruit, develop, and retain a scientific and operationally capable workforce skilled and knowledgeable in pharmacovigilance and risk management including Benefit-Risk, REMS, and risk minimization.
Effectively manage an agile Benefit-Risk Scientist group that continuously meets the needs of a changing portfolio.
Build a culture that fosters inclusion and innovation.
Develop staff who demonstrate expertise in drug development, therapeutic area science, project management and cross-functional leadership.
Develop a Benefit-Risk scientist talent base that demonstrates judgment-based decision making and provides leadership in drug development and pharmacovigilance.
6) 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.
Minimum Qualification Requirements:
Bachelor's Degree in a science or health-related field, pharmacy, or nursing.
10+ years’ experience in pharmaceutical medicine, pharmacovigilance, or drug development.
Demonstrated effective people leadership.
Knowledge of global and local PV regulations and legislation, pre- and post-marketing.
Experience in Benefit-Risk, Risk Management
Experience in PV audits and inspections
Other Information/Additional Preferences:
Critical, strategic thinking and decision-making skills.
Operates well across boundaries.
Excellent written and verbal communication skills.
Excellent interpersonal, influencing and negotiation skills.
Established record of successfully developing employees.
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.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $222,200Full-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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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Eli Lilly and Company Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Eli Lilly and Company and has not been reviewed or approved by Eli Lilly and Company.
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Retirement Support — Feedback suggests long-term savings are bolstered by a defined-benefit pension alongside a company 401(k) match and retiree health options. These elements make total compensation feel strong beyond base salary.
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Leave & Time Off Breadth — Feedback suggests paid time off is expansive, with substantial vacation, company shutdown days, and milestone time. This breadth of leave is viewed as a meaningful part of overall rewards.
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Parental & Family Support — Feedback suggests family-building and caregiving support are robust, including paid parental leave, adoption or surrogacy assistance, and backup care. These programs enhance the perceived value of benefits across life stages.
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What We Do
Eli Lilly and Company engages in the discovery, development, manufacture, and sale of products in pharmaceutical products business segment. For more than a century, we have stayed true to a core set of values – excellence, integrity, and respect for people – that guide us in all we do: discovering medicines that meet real needs, improving the understanding and management of disease, and giving back to communities through philanthropy and volunteerism.
