Eli Lilly and Company

Full-stack Engineer

• Design, build, deploy, and sustain full-stack applications, data services, workflow tools, and automation for scientific and operational users
• Partner with scientists, engineers, informatics teams, and business stakeholders to identify needs, clarify requirements, and define practical deliverables
• Simplify processes, reduce manual handoffs and duplicative data entry, and connect fragmented data and systems
• Build and maintain APIs, data models, and access layers across scientific, operational, enterprise, and vendor data sources
• Integrate applications with laboratory systems, data pipelines, analysis environments, and enterprise platforms
• Apply standards for data quality, provenance, versioning, security, and access control
• Develop AI-enabled capabilities for information retrieval, natural-language data access, extraction, annotation, and summarization
• Use AI-assisted development tools while maintaining standards for code review, testing, security, and ownership
• Evaluate technology options and recommend custom development, configuration, integration, reuse, purchase, process change, or retirement
• Contribute to version control, peer review, automated testing, CI/CD, containerization, observability, and dependency management
• Deploy and operate applications on Lilly cloud infrastructure in partnership with Tech@Lilly and Information Security
• Own application reliability, user support, documentation, maintenance, and lifecycle planning
• Mentor junior engineers, co-ops, and scientist-developers as appropriate

Software Engineer, Oncology Applications

Director

• Lead investigations into fraud, knockoff products, and other civil and criminal violations
• Create strategies to combat fraud and illicit distribution of knockoff drugs and promote brand protection
• Triage incoming reports and coordinate matters from intake through disposition
• Drive change and process improvement with cross-functional stakeholders
• Collaborate with lawyers, investigators, intelligence analysts, business partners, forensic laboratory analysts, and data experts
• Identify new investigative avenues using forensic technology and software
• Monitor channels for new violations
• Build relationships with law enforcement and regulatory authorities worldwide
• Develop cases for referral and support resulting criminal prosecutions and civil actions
• Document reports and case information in internal case management systems
• Maintain confidential information, use discretion in sensitive investigations, comply with applicable laws, and preserve privileges
• Support internal partners, regulators, and law enforcement
• Work outside normal daytime hours as business needs require
• Travel domestically and internationally periodically

Associate Director – Special Investigations

General Counsel

• Develop comprehensive global patent strategies for key pharmaceutical assets
• Develop patent application filing strategies covering innovations from discovery, clinical development, manufacturing, and beyond
• Draft and prosecute patent applications in all jurisdictions
• Assess freedom to operate
• Analyze IP risks and develop strategic and tactical solutions aligned with business objectives and the competitive environment
• Advise teams and senior management on exclusivity, patentability, freedom to operate, and risks
• Communicate legal advice clearly and concisely
• Stay current on global laws, court precedents, and regulations relevant to pharmaceutical products
• Identify opportunities for continuous improvement within the team and organization
• Prioritize, lead, and manage projects
• Contribute to implementing new policies and procedures
• Lead task-directed teams
• Contribute to efficiency, collegiality, and collaboration
• Collaborate with Lilly Legal Patent team members, project teams, and business leadership
• Report to the Associate Vice President – IP Procurement and Strategy

Associate VP – Assistant General Patent Counsel, IP Procurement

• Provide post-execution legal support for license, collaboration, M&A, and other agreements in Lilly's infectious disease and vaccines portfolio
• Advise Alliance Management and other functions managing ongoing contractual relationships
• Prepare, review, and negotiate complex R&D and commercial agreements
• Advise on government and BARDA-related contracting, CRADAs, and public-private collaboration structures
• Support Lilly Research Labs projects and workstreams across therapeutic areas and geographies
• Manage governance, milestones, royalties, reporting obligations, dispute resolution, termination, and other agreement lifecycle issues
• Support integration of newly acquired infectious disease and vaccine assets and platforms
• Identify and resolve sophisticated legal issues and drive successful business outcomes
• Ensure agreements comply with applicable laws, regulations, and guidelines
• Provide clear strategic advice to legal leadership and business clients
• Translate complex technical, performance, and legal issues into understandable terms
• Partner with Regulatory Legal and other legal subject-matter experts
• Take ownership of matters and projects in a new and growing business area
• Represent Lilly externally to partners, customers, suppliers, and government counterparties
• Negotiate legal issues and help direct outside counsel

Senior Director – Counsel, Alliance Management and Transactions, Infectious Disease & Vaccines

Clinical Research

• Progress multiple early clinical assets into first-in-human studies or support further development through clinical pharmacology and mechanistic studies
• Develop, conduct, and report global clinical trials for new compounds
• Implement global clinical trials and report adverse events according to corporate patient-safety requirements
• Review protocols, study reports, publications, data dissemination, product labels, grant submissions, contracts, and regulatory materials
• Conduct outreach to external clinical customers and thought leaders
• Ensure medical-team activities comply with local and international regulations, FDA, ICH, CPMP, GCPs, company standards, and Lilly policies
• Work with basic research scientists to plan pre-clinical studies and develop biomarker plans
• Serve as a scientific and medical resource for study teams and departments
• Contribute to clinical development strategies and plans for clinical compounds
• Support first-in-human dosing preparations, Phase 2 and 3 planning, and biopharmaceutical submission planning
• Collaborate with Global Patient Safety, PK/PD, ADME, Statistics, Tailored Therapeutics, and quantitative-science teams
• Work with discovery research scientists on research strategies, candidate selection, and pre-clinical development
• Collaborate with Brand Team and Business Unit colleagues on market differentiation and regulatory support
• Design and oversee clinical pharmacology, mechanistic, development, and biomarker qualification studies
• Develop protocols and study-conduct documents in accordance with GCP and local requirements
• Collaborate with clinical research staff, statisticians, health outcomes scientists, consultants, and investigators
• Participate in investigator identification and selection
• Review risk profiles and informed-consent documents
• Oversee ethical review, informed consent, regulatory approval/notification, study start-up, training, and site activities
• Advise clinical trial managers, monitors, investigators, and ethical review boards during studies
• Monitor patient safety, track and follow up adverse events, and implement pharmacovigilance actions
• Provide oversight and partnership to third-party organizations for study execution
• Address scientific questions from external healthcare professionals
• Participate in clinical trial registry reporting, publication strategy, scientific communications, data analysis, final reports, and publications
• Present clinical trial results to corporate committees, regulatory agencies, and external agencies
• Prepare clinical reports and regulatory reports, including medical sections of INDs and Investigator Brochures
• Support FDA advisory committee hearings, label discussions, and regulatory issue resolution
• Develop and retain a scientifically excellent workforce and foster inclusion, innovation, and continual improvement
• Support commercialization and medical strategies with business units, New Product Planning, and business development
• Maintain relationships with external experts and opinion leaders
• Support business-to-business and business-to-government activities as a medical expert
• Contribute to ongoing strategic brand planning and understand market archetypes

Director – Clinical Pharmacologist, Clinical Research Physician

Medical Director

• Participate in development, conduct and reporting of global clinical trials for compounds in the cardiometabolic research therapeutic area, including women’s health
• Support implementation of global clinical trials and report adverse events according to corporate patient-safety requirements
• Review protocols, study reports, publications, data dissemination, labels, grant submissions, contracts, and regulatory interactions
• Assess licensing opportunities and conduct outreach to external clinical customers
• Work with research scientists to identify lead compounds and clinical candidates and plan pre-clinical studies
• Provide internal training, peer review of clinical protocols and reports, and ad hoc scientific consultation
• Work with late-stage development colleagues to plan clinical studies, outcomes research, and pharmacoeconomic research
• Contribute to clinical development strategy and plans for early-phase compounds
• Collaborate on design, conduct and reporting of Phase Ib and IIa/IIb trials
• Integrate clinical studies with PK/PD, statistics, molecular epidemiology, ADME, modeling and simulation approaches
• Design and write clinical trial protocols and oversee study implementation
• Collaborate with investigators, consultants, clinical research staff, statisticians and health outcomes researchers
• Monitor patient safety and track and follow up adverse events
• Support clinical trial data analysis, reporting, publications, presentations, symposia and advisory boards
• Support regulatory reports, IND and Investigator Brochure medical sections, FDA advisory committee hearings, labeling modifications and risk management planning
• Provide medical expertise to regulatory scientists and business units
• Advise on potential markets for development and licensed compounds and support business development
• Build relationships with external experts, thought leaders, professional societies and the medical community
• Participate in patent development and define the Patient Journey and Moments of Truth
• Maintain current knowledge of medical literature, clinical practice, pre-clinical and clinical data, and therapeutic-area developments
• Set professional development goals, coach colleagues, participate in recruitment and retention efforts, and lead matrixed cross-functional teams

Director – Medical, Clinical Research Physician

• Lead development, management, execution, and oversight of safety programs for assigned assets throughout their product life cycles
• Coordinate technical functions within GPS and partner with integrated development or product teams
• Provide proactive pharmacovigilance and medical review of individual case safety reports
• Oversee surveillance activities, safety signal decisions, risk management actions, and regulatory safety queries
• Lead GPS Medical activities during acquisitions and integrations of new companies or assets
• Synthesize complex data into actionable insights and translate technical issues into strategic discussions
• Represent Lilly GPS Medical to internal and external stakeholders, including product, business, regulatory, affiliate medical, clinical research, and external opinion leaders
• Review external regulatory policy and trends affecting Global Patient Safety
• Represent GPS Medical in inspections and audits
• Provide medical assessment and decision-making for product safety assessments, health hazard evaluations, device risk management, CMC activities, anticounterfeiting, product shortages, quality triage, and regulatory reporting
• Evaluate adverse events for possible manufacturing-related root causes
• Implement PSA/HHE processes with manufacturing and marketing partners
• Prepare medical complaints and review or approve manufacturing investigation results
• Monitor unanticipated safety impacts related to deviations addressed by HHEs
• Foster a collaborative Team Lilly environment
• Recruit, mentor, develop, and retain clinical, scientific, and drug development talent
• Ensure staff compliance with company policies and procedures
• Support the European Union Qualified Person (QPPV) in fulfilling legal responsibilities
• Provide training, coaching, and mentorship on pharmacovigilance strategies
• Maintain compliance with Lilly policies, curricula, and Corporate Integrity Agreement

Executive Director – Clinical Research Physician

Translator

• Set strategy and technical direction for oligonucleotide process transfers across programs
• Serve as escalation point for complex troubleshooting and technology adoption decisions
• Define scale-up approach for synthesis and purification methods from early-phase process R&D
• Serve as technical authority on oligonucleotide unit operations, including solid phase synthesis, preparative chromatography, TFF, and lyophilization
• Partner with safety and process engineering leadership to shape procedure evaluation standards and approve high-risk or novel procedures
• Translate analytical data into strategic technical recommendations for program and site leadership
• Represent process chemistry and technical challenges to senior leadership and cross-functional stakeholders
• Set standards for plant readiness assessment across synthesis, cleavage, purification, TFF, and lyophilization
• Establish frameworks for use-tests and Definitive Lab Trials confirming plant readiness
• Own technical quality and consistency of documentation, including tech transfer plans, SOPs, batch records, campaign summary reports, and deviation reports
• Drive site-wide process improvement and adoption of new technologies or procedures
• Lead complex process investigations and CAPAs
• Partner with CMC, Product R&D, Manufacturing, and Quality leadership
• Mentor principal and senior scientists and inform PTE training standards

Advisor – Mixed Modality Scientist, Oligonucleotide – Process Translation and Execution

• Provide in-depth and cutting-edge scientific and clinical information to scientific and clinical experts
• Synthesize the latest research on products, disease states, and standards of care for assigned indications and therapeutic areas
• Establish credibility as a reliable, trusted source of unbiased, accurate, and current medical and scientific information
• Support healthcare professionals in sharing evidence and addressing clinical care gaps to improve patient outcomes
• Connect scientific and clinical experts with Lilly resources and internal business partners
• Facilitate collaborative research opportunities
• Partner with clinical development on studies and investigators to accelerate pipeline and evidence generation
• Deliver disease-state and scientific information aligned with site identification, selection, and recruitment
• Analyze customer data and prioritize engagement with assigned scientific and clinical experts through face-to-face and virtual interactions
• Implement strategic territory plans and use analytical tools for execution
• Coordinate compliantly with Lilly field roles sharing customers
• Use territory analytics for customer identification and routing prioritization
• Synthesize and communicate actionable customer and clinical insights to Lilly Medical and cross-functional teams
• Cultivate internal networks and collaborate across functions with field-based colleagues
• Contribute to team goals and work collaboratively with peers and Lilly colleagues
• Execute the role compliantly while adhering to governing requirements, procedures, and laws

Associate Director – Medical Science Liaison, Oncology, GI/Thoracic Focus

• Provide scientific and strategic leadership for translational clinical pharmacology across a diverse pipeline from early development through late-stage and registrational programs
• Develop and execute clinical pharmacology strategies addressing CNS exposure, dose optimization, and translational relevance
• Lead collection and interpretation of in vitro, in vivo, literature, competitive-source, and clinical data to develop a translational knowledge base
• Drive dose selection and optimization by integrating PK, PD, safety, efficacy, and CNS-specific biomarkers
• Lead model-informed drug development, including population PK, PK/PD, and exposure–response analyses
• Assess and guide strategies for CNS exposure, brain penetration, target engagement, and translational biomarkers
• Lead clinical pharmacology strategy for CNS and neuroscience programs from first-in-human through registrational and post-marketing stages
• Design, execute, and interpret clinical pharmacology studies, including FIH, multiple-ascending dose, DDI, biopharmaceutics, and patient studies
• Serve as clinical pharmacology lead on program teams, clinical sub-teams, and trial working groups
• Author and oversee clinical pharmacology sections of regulatory documents, including INDs, CTAs, IBs, and NDAs
• Represent clinical pharmacology in interactions with FDA and other global health authorities
• Partner with DMPK, Translational Sciences, Clinical Development, Biomarkers, Biostatistics, CMC, and Regulatory Affairs
• Oversee CROs and external vendors conducting clinical pharmacology and modeling activities
• Communicate and interpret clinical pharmacology results to internal stakeholders
• Contribute to portfolio strategy, program prioritization, risk mitigation, and long-range clinical development planning for CNS assets
• Serve as a subject-matter expert on clinical pharmacology
• Mentor and develop clinical pharmacology talent
• Ensure high-quality, submission-ready documentation aligned with global regulatory standards

Senior Director, Clinical Pharmacology/Translational

• Lead early clinical development strategy for Lilly’s Aesthetic Medicine portfolio
• Collaborate with discovery, translational medicine, and clinical teams to develop therapeutic hypotheses for skin health, facial aesthetics, and body aesthetics
• Participate in target and modality selection and portfolio prioritization
• Evaluate and diligence external discovery and early clinical opportunities for partnerships or acquisitions
• Provide scientific and clinical expertise to portfolio strategy and investment decisions
• Design early clinical studies that efficiently test therapeutic hypotheses
• Collaborate with clinical pharmacology, biostatistics, regulatory affairs, operations, HEOR, and other stakeholders on study design and execution
• Integrate translational endpoints, biomarker strategies, aesthetic scales, and patient-reported outcomes into early studies
• Contribute to pre-IND, IND, ex-US health authority interactions, submissions, and regulatory strategy
• Monitor patient safety and ensure compliance with GCP, FDA, ICH guidelines, and company policies
• Drive innovative experimental medicine from first-in-human through proof-of-concept
• Serve as scientific and medical expert across multiple therapeutic programs
• Lead cross-functional teams through matrix influence and facilitate decisions across discovery, development, and commercial functions
• Mentor junior team members and build scientific capabilities
• Establish relationships with key opinion leaders and scientific experts in aesthetic medicine, dermatology, and plastic surgery
• Represent Lilly at conferences, advisory boards, and industry forums
• Support business development through clinical scientific due diligence
• Identify, evaluate, and execute strategic partnerships with CROs, biotech companies, academic institutions, and research organizations
• Partner with regulatory colleagues on IND strategy, FDA interactions, and global development planning
• Support risk management planning and safety signal evaluation
• Participate in data analysis, scientific publications, and medical communications
• Help shape development strategy and regulatory positioning for early-stage aesthetic medicine assets
• Report to the Head of Early Clinical Development, Immunology & Aesthetic Medicine

Executive Medical Director – Early Clinical Development, Aesthetic Medicine

• Lead investigations into fraud, knockoff products, and other civil and criminal violations
• Create strategies to combat fraud and illicit distribution of knockoff drugs and promote brand protection
• Triage incoming reports and coordinate matters from intake through disposition
• Drive change and process improvement with cross-functional stakeholders
• Collaborate with lawyers, investigators, intelligence analysts, business partners, forensic laboratory analysts, and data experts
• Identify new avenues for investigations using forensic technology and software
• Monitor channels for new violations
• Build and sustain relationships with law enforcement and regulatory authorities worldwide
• Develop cases for referral and support resulting criminal prosecutions and civil actions
• Document reports and case information in internal case management systems
• Protect confidential company information, use discretion in sensitive investigations, comply with national and local laws, and preserve applicable privileges
• Report to the Associate Vice President, Assistant General Counsel – Special Investigations
• Work outside normal daytime hours when business needs require
• Travel periodically domestically and internationally

Associate Director, Special Investigations

• Progress multiple early clinical assets into first-in-human studies or support further development through clinical pharmacology and mechanistic studies
• Develop, conduct and report global clinical trials for new compounds
• Implement global clinical trials and report adverse events according to corporate patient safety requirements
• Review protocols, study reports, publications, data dissemination, labels, grant submissions, contracts and regulatory materials
• Plan clinical strategies and clinical development programs for regulatory submissions
• Support first-in-human dosing studies and biomarker plans
• Collaborate with Global Patient Safety, PK/PD, ADME, Statistics and Tailored Therapeutics teams
• Work with discovery research scientists on research strategies, candidate selection and pre-clinical development
• Design and oversee clinical pharmacology studies, biomarker qualification studies and protocol development
• Support study documents and collaborate with clinical research staff, statisticians, health outcomes scientists, consultants and investigators
• Participate in investigator identification and selection, study start-up meetings and investigator/site training
• Oversee ethical review, informed consent, regulatory approvals and study initiation requirements
• Serve as a resource to clinical trial managers, monitors, investigators and ethical review boards
• Monitor patient safety and implement pharmacovigilance actions
• Oversee partnerships with Third Party Organizations for study execution
• Address scientific questions from external health care professionals
• Participate in clinical trial registry activities, publication strategy, data analysis and final reports
• Present clinical trial results to corporate committees, regulatory agencies and external agencies
• Prepare clinical reports and regulatory submissions, including medical sections of INDs and Investigator Brochures
• Develop and retain a scientifically excellent workforce and foster inclusion, innovation and continual improvement
• Support medical strategies for brand commercialization, business development and strategic brand planning
• Maintain relationships with external experts and opinion leaders and support business-to-business and business-to-government activities

Director – Clinical Pharmacologist / Clinical Research Scientist

• Participate in development, conduct, and reporting of global clinical trials for new compounds
• Implement global clinical trials and report adverse events according to corporate patient-safety requirements
• Review protocols, study reports, publications, data dissemination, product labels, grant submissions, and contracts
• Interact with regulatory and governmental agencies
• Assess licensing opportunities and conduct outreach to the external clinical customer community
• Work with research scientists to identify lead compounds and clinical candidates and plan pre-clinical studies
• Provide internal training, peer review of clinical protocols and reports, and ad hoc scientific consultation
• Plan clinical studies, outcomes research, and pharmacoeconomic research to meet patient needs
• Develop clinical strategies and plans for compounds, including Phase III planning
• Design and oversee Phase Ib and Phase IIa/IIb clinical studies and write clinical trial protocols
• Collaborate with clinical research staff, investigators, statisticians, quantitative scientists, pharmacologists, and other cross-functional partners
• Oversee study initiation, regulatory approvals, ethical review, informed consent, training, monitoring, and patient safety
• Participate in data analysis, clinical trial registry reporting, final reports, publications, presentations, symposia, advisory boards, and congress activities
• Support regulatory reports, IND and Investigator Brochure medical sections, FDA advisory committee hearings, labeling modifications, and risk management planning
• Provide medical and scientific advice to business units, payers, patients, healthcare providers, marketing, and management
• Maintain relationships with external experts, thought leaders, professional societies, and the broader medical community
• Participate in business development, patent development, committees, initiatives, task forces, recruitment, diversity, and retention efforts
• Lead matrixed cross-functional teams and serve as a patient and Lilly brand ambassador
• Maintain current knowledge of medical literature, clinical practice, preclinical and clinical data, and scientific developments

Director, Medical – Clinical Research Scientist

Operations

• Lead and develop the US-based Identity Operations team, including hiring, coaching, career development, and performance management
• Partner with the Associate Director of Identity Operations to align the US team with the global operations organization
• Foster a culture focused on security, innovation, automation, continuous learning, and operational rigor
• Own the strategic vision and multi-year roadmap for Identity Operations
• Establish and maintain the framework for operational tooling and architecture
• Define technology strategy for monitoring, alerting, patching, automation, and orchestration platforms
• Manage lifecycle management, vulnerability management, and vendor strategy for Operations tools
• Champion automation, agentic AI, and CI/CD practices to reduce manual toil and improve operations
• Improve organizational change and problem management processes
• Translate incident and problem trends into strategic backlog items and long-term improvements
• Serve as a senior escalation point for identity service incidents
• Support decision-making and executive-level communication during high-priority incidents
• Partner on post-incident reviews and drive systemic improvements into the strategic roadmap
• Partner with Identity Service leads, Architects, and Cybersecurity leaders to align Operations strategy with broader identity services strategy
• Represent Operations strategy and priorities in cross-functional and leadership forums
• Engage vendors on strategic partnerships supporting Operations platforms and tooling
• Ensure Operations governance processes and controls support regulatory and industry compliance
• Coordinate audit response for the Operations governance domain