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.

MINIMUM QUALIFICATION REQUIREMENTS:

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• 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, both pre- and post-marketing, is required.
• Experience in facilitating safety surveillance activities (including but not limited to Signal Management, Risk Management and Periodic Aggregate Safety Reporting).
• Experience in PV audits and inspections.

The purpose of the Senior Director/Executive Director, Clinical Surveillance Scientist Group Leader, is to provide strategic leadership for the effective scientific execution of safety surveillance, signal management, risk management and periodic aggregate safety reporting accountabilities within the GPS Safety Science organization. Key responsibilities include oversight of the Clinical Surveillance Scientist group, providing strategic leadership for Safety Science-related activities, and representing PV Science on cross-functional teams. The Senior Director/Executive Director will ensure that the Clinical Surveillance Scientist group operates in and maintains a high level of compliance with both internal and external expectations. This role will ensure that appropriate Scientist resources are allocated to lifecycle pharmacovigilance (signal management, risk management, aggregate periodic reporting) activities for all Lilly products, and in support of the European Union Qualified Person for Pharmacovigilance (EU QPPV). This role reports to the Associate Vice President, GPS Safety Science.
Primary Responsibilities:

Pharmacovigilance Leadership

• Oversee clinical surveillance scientist group members in lifecycle PV activities, including signal management, safety governance meetings, preparation of periodic aggregate safety reports, preparation of risk management plans and other clinical trial (e.g., protocols, investigator brochures, informed consent/assent forms) and/or post-marketing activities.
• 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.
• 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.

Enterprise Leadership

• Exhibit strong business acumen, strong problem-solving skills and agility to adjust to changing business priorities and needs.
• Represent Clinical Surveillance at appropriate internal and external venues.
• Maintain awareness of regulatory requirements, particularly those related to the US, EU, Japan, and China
• 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.

People Management and Development

• Recruit, develop, and retain a scientific and operationally capable workforce skilled and knowledgeable in pharmacovigilance and safety sciences including safety surveillance, signal detection and periodic safety reporting.
• Effectively manage an agile 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 clinical surveillance talent base that demonstrates judgment-based decision making and provides leadership in drug development and pharmacovigilance.

  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.