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 - Signal Management Group Leader, is to provide strategic leadership for the effective design, development, and implementation of operating policies and procedures for maintaining and managing Lilly’s end-to-end Signal Management Processes and associated metrics throughout the product lifecycle ensuring signal detection, evaluation and management processes meet the highest standards. This role will spearhead the redesign and future-state advancement of Signal Management science defining and driving the strategic roadmap for process transformation, digital enablement, and operational excellence.

Key responsibilities include oversight of the GPS Signal Management Scientist group, providing strategic leadership for Safety Science related activities and representing Signal Management and Safety Science on cross-functional teams. This role is accountable for establishing and maintaining signal management and safety governance 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 Signal Management group maintains compliance with current regulations, ensuring efficient implementation of signal management activities through monitoring of key performance indicators, supporting continuous improvement of the team. This role will ensure that appropriate Signal Management resources are allocated for all Lilly products, and in support of the European Union Qualified Person for Pharmacovigilance (EU QPPV).

Signal Management Leadership

1) End-to-End Business Process Ownership

Acts as strategic business process owner for Signal Management providing end-to-end ownership, vision, and governance to ensure alignment with regulatory requirements and business goals.

Serves as functional process owner of SOPs, required tools, and templates for signal management and safety governance.

Provides expertise to ensure processes are executed according to guidance, regulations, and internal procedures.

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 signal detection, risk management, and periodic aggregate safety reporting, contributing to proactive safety strategies and regulatory compliance on a global scale.

Establishes clear signal management processes, including inputs, outputs, dependencies, and accountability, partnering with stakeholders to design efficient and compliant processes.

Ensure committees and processes adhere to guidance, regulations, and internal procedures.

Serves as primary point of escalation for process-related issues, ensuring timely resolution.

Provide governance, lead the implementations of improvement initiatives, and foster a robust compliance mindset.

Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitate accurate reporting and analytics.

Leads cross-functional teams in process improvement activities, including documentation and personnel qualification.

Develops and maintains signal management training in collaboration with Learning & Development.

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.

As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed.

Participate in audits and inspections as required.

2) Quality Metrics and Oversight

Establishes key performance measures and compliance metrics for signal detection and 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 Signal Management processes and activities ensuring compliance with regulations and regulatory authority and inspectors’ expectations.

3) Signal Management Science Innovation

Define and drive the strategic roadmap for the process, identifying opportunities for transformation, digital enablement, and operational excellence.

Develop 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 signal management and other core safety science functions, including clinical development safety, periodic aggregate safety reporting and benefit-risk 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 Signal Management and Safety Sciences at appropriate internal and external venues.

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 Signal Management

Maintain awareness of regulatory requirements and the changing regulatory landscape.

Ensure that activities are performed according to established guidelines, best practices, and in compliance with all laws and regulations.

Drive shared learning and process expertise between teams within the organization.

Operate as key influencer across cross-functional teams and stakeholders to ensure adoption of process improvements, system enhancements and policy changes.

Lead negotiation and alignment across diverse stakeholder groups to balance competing priorities, balance risk and efficiency, and drive consensus in complex decision-making environments.

Provide strategic input for the integration and delivery of mergers and acquisitions. Collaborate with cross-functional teams and acquisition teams to ensure seamless integration, optimize processes, and achieve business objectives.

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.

5) Signal Management Team Creation and Implementation

Build a new Signal Management Scientist team responsible for signal management activities as well as any data output reports under the responsibility of the group in collaboration with the contributing teams outside the Global Patient Safety Organization.

Recruit, develop, and retain a scientific and operationally capable workforce skilled and knowledgeable in pharmacovigilance and signal management including safety surveillance, signal detection and periodic safety reporting.

Effectively manage an agile Signal Management 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 signal management scientist talent base that demonstrates judgment-based decision making and provides leadership in drug development and pharmacovigilance.

Partner closely with other Global Patient Safety, Regulatory, Development and other functions to effectively plan, forecast, and manage the resources required to deliver all sanctioned projects.

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:

Bachelors 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, both pre- and post-marketing required.

Experience in Signal Management, Risk Management and Periodic Aggregate Safety Reporting.

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 - $222,200

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).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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