Jobs at Eli Lilly and Company

Leads global quality system governance and improvement for commercial and clinical supply processes. Provides oversight, consulting, process monitoring, management review, and governance across the Operational Controls pillar. Partners with manufacturing, suppliers, quality operations, R&D, and Clinical Supply to manage risks, strengthen capabilities, standardize processes, maintain compliance, and support inspection readiness. The role monitors regulatory developments and advances QMS standards, training, tools, and effectiveness measures.

Performs 100% manual visual statistical inspection of parenteral products, classifies and documents defects, delivers samples to QC laboratories, supports investigations, and helps train and qualify inspection operators. Ensures Good Documentation Practices, GMP compliance, safety, and accurate inspection records while supporting production schedules and off-shift activities.

Implement next-generation MES across manufacturing sites: define and execute integrated deployment plans, align solutions with global standards and digital initiatives, serve as site/team point of contact, enable change management and user adoption, develop training and support models, and partner with site and global project leaders to ensure validated, compliant MES deployments.

The Senior Director HSE oversees the development and implementation of health, safety, and environmental programs at the Concord Plant, ensuring compliance and managing HSE teams. Key responsibilities include program ownership, regulatory reporting, and fostering team cultures for a safe work environment.

Support and maintain QC laboratory IT systems (LIMS, ELN, SDMS, Empower) to ensure validated state, data integrity, and regulatory compliance. Install, configure, and qualify systems; act as SME for audits, training, documentation, continuous improvement, and monitoring of laboratory IT operations.

Own end-to-end security architecture and risk posture for a strategic, AWS-heavy program protecting trade secrets and sensitive intellectual property. Lead cloud and application security reviews, threat modeling, risk assessments, control design, and risk acceptance. Develop secure reference architectures, design patterns, standards, and guidance across cloud platforms, data flows, identity, and integrations. Provide technical leadership, mentorship, and security direction while communicating risks effectively to technical, business, audit, and executive stakeholders.

Leads early-phase clinical development and clinical pharmacology studies from first-in-human planning through execution, analysis, reporting, and regulatory submission. Designs protocols, oversees clinical trials, monitors patient safety, supports biomarker and preclinical strategies, ensures GCP and regulatory compliance, disseminates scientific data, collaborates with cross-functional teams and external experts, and contributes to commercialization and medical strategy. The role also includes developing scientific talent and managing teams.

Leads clinical development programs for diagnostic radiopharmaceutical imaging across oncology, immunology, and cardiovascular disease. Defines study strategies, endpoints, imaging criteria, biomarkers, and patient populations; interprets molecular imaging data and performance metrics; guides image-analysis validation; and collaborates with physicians, scientists, CROs, academics, software developers, and scanner manufacturers. Authors clinical and regulatory documents, evaluates emerging imaging technologies and AI, and communicates findings through presentations and publications.

Provides statistical leadership for pharmaceutical clinical development programs, including trial design, protocol and statistical analysis plan development, data analysis, regulatory submissions, scientific communications, and interpretation of results. Leads innovative statistical methodology, collaborates across data sciences and therapeutic-area teams, responds to regulators, peer-reviews statistical work, and influences clinical and business decisions.

Leads Lilly’s enterprise pandemic preparedness, infectious disease risk management, and public health emergency response strategy. Establishes governance, readiness metrics, response plans, continuity strategies, and crisis leadership structures across research, clinical development, manufacturing, supply chain, and corporate functions. Monitors infectious disease intelligence, advises executives and the Board, coordinates cross-functional emergency responses, develops public health partnerships, and oversees preparedness training, simulations, and after-action programs.

Leads clinical data management for global development programs, including data strategy, electronic trial system implementation, data standards, validation, quality oversight, vendor management, reporting, documentation, and regulatory compliance. Partners with CROs and cross-functional teams to deliver accurate, timely clinical data and support submissions, inspection readiness, and clinical milestones across complex Phase I–III studies.

Leads LillyDirect’s forward-looking Consumer and HCP marketing strategy, growth investments, content briefing, innovation pipeline, competitive intelligence, and partnership alignment. Sets goals, KPIs, budgets, and testing strategies; advises senior leadership on investment priorities and scales successful marketing initiatives. Manages and develops marketing talent while fostering an inclusive, high-performing culture.

Leads clinical development programs for diagnostic radiopharmaceutical imaging across oncology, immunology, and cardiovascular disease. Defines study strategies, endpoints, imaging criteria, biomarkers, and patient populations; analyzes PET, SPECT, CT, and MRI data; evaluates imaging performance and advanced image analysis methods; and guides regulatory documentation. Collaborates with physicians, scientists, physicists, CROs, academics, software developers, and scanner manufacturers while communicating findings through publications and presentations.

Provide strategic patent counseling for key pharmaceutical assets: develop global patent filing and prosecution strategies, assess freedom-to-operate and IP risk, advise senior management, lead projects and task-directed teams, and drive continuous improvement in patent practice.