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. Job title: Senior Director/Executive Director, Clinical Surveillance Scientist Group Leader Location: Bracknell (UK) or Indianapolis (US) Hybrid working: 3/2 Reports to: Associate Vice President, GPS Safety Science ABOUT LILLY: Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. ROLE OVERVIEW: As the Senior Director/Executive Director, Clinical Surveillance Scientist Group Leader, you will 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. You will ensure that the Clinical Surveillance Scientist group operates in and maintains a high level of compliance with both internal and external expectations. Furthermore, 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). MAIN RESPONSIBILITIES INCLUDE: 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. BASIC 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, 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. YOU WILL SUCCEED IN THIS ROLE IF: You will succeed in this role if you bring strong critical and strategic thinking, paired with sound decision-making capabilities. Your ability to operate effectively across boundaries and collaborate across functions will be key to managing complex initiatives. Exceptional written and verbal communication skills, along with interpersonal, influencing, and negotiation strengths, will enable you to build trusted relationships and drive meaningful outcomes. A proven track record in developing talent, improving processes, and implementing excellence initiatives will set you apart. Your organizational and project management skills, combined with the ability to prioritize and lead with clarity, will ensure success in a dynamic and fast-paced environment. EMBRACING DIVERSITY: Embracing diversity is at the core of our long-held value of respect for people. It is the lens through which we understand and respond to the unique needs of the millions of individuals who depend on our medicines. For us, embracing diversity means understanding, respecting, and valuing differences, including but not limited to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. The greatest measure of our diversity efforts is our ability to attract and retain exceptional employees who feel comfortable in a culture that supports them being themselves. LI-LD2 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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. WeAreLillyUKandIreland