GPS Case Management Medical Review Therapeutic Area Leader

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life‑changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. Leadership in Medical Review Supervise Case Management Medical Review personnel within the therapeutic area across the global team, including physicians and scientists. Build deep regulatory and technical expertise through recruitment, development, and retention of staff. Facilitate, train and mentor Case Management Medical Reviewers in the responsibilities of the role. Provide feedback and coaching, support short and long‑term development plans, and ensure appropriate individual recognition. Oversee the medical evaluation of safety of Individual Case Safety Reports for all assigned compounds across their life cycle to inform the safety profile of the therapeutic area portfolio. Develop, maintain, and share technical expertise and medical knowledge in the therapeutic area. Provide strong global medical leadership that influences scientific and process improvements and drive change within the organization. Lead and participate in process improvement and innovation projects to support the safety of all assigned compounds. Participate in the development and implementation of the functional strategic plan for Case Management Medical Review. Manage resources to meet business objectives and future needs within the therapeutic area in collaboration with leaders across the global team. Collaborate cross‑functionally to ensure alignment of goals and deliverables, readjusting as business needs dictate. Partner closely with global GPS partners for efficient resource forecasting, planning, and utilization to meet business objectives. Enterprise Leadership Lead actions and collaborate with GPS teams to ensure appropriate interaction, communication, and high‑quality medical evaluation of safety within the therapeutic area. Act as a Lilly Case Management Medical Review representative for both internal and external customers, interacting as described in corporate guidelines and policies. Build strong relationships with key customers, representing and championing the role of safety in the organization. Collaborate with Affiliates, Business Units, and Clinical Development teams regarding areas of relevant medical review expertise and responsibility. Lead actions required to manage or clarify a safety issue in collaboration with the responsible global teams. Understand the roles and responsibilities of the EU qualified person (QP) and ensure support to the fulfillment of QP’s legal responsibilities is provided when required. Minimum Qualification Requirements BS degree in health‑related or scientific field with 7 years of experience in pharmaceutical industry, directly related clinical trial experience or experience in areas relevant to drug discovery or development, e.g. epidemiology, toxicology, pharmacovigilance, regulatory affairs. 2 years of clinical development experience Experience in the drug development process. Additional Preferences 5 years of clinical development or pharmacovigilance experience preferred. Advanced medical related graduate degree, such as: DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 1-3 years’ experience in related scientific field, e.g. pharmacology, physiology, microbiology or scientifically related field. OR Knowledge of drug development process. Fluent in English with highly effective written and verbal communication skills. Strong clinical/diagnostic skills. Excellent interpersonal, organizational and negotiation skills. Ability to work on multiple projects and function effectively in a fast‑paced matrixed environment. Ability to prioritize tasks and shift priorities rapidly to meet tight deadlines Ability to influence others (both cross‑functionally and within the function) in order to create a positive working environment. Excellent teamwork skills. Willing to engage in domestic and international travel to the degree appropriate to support the business of the team. 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 ( 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. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $156,000 - $228,800 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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