Eli Lilly and Company

Analyst

• Lead the continued development and maturation of the Cyber Threat Intelligence function
• Maintain personal technical proficiency in threat analysis, attribution, and intelligence tradecraft
• Direct the threat actor tracking and attribution program
• Lead the cyber threat intelligence components of brand and executive protection
• Develop and maintain strong working relationships with key partners across Cybersecurity
• Strengthen Lilly's role in intelligence sharing communities
• Lead a team of cyber threat intelligence analysts
• Direct the evaluation, introduction, and integration of capabilities supporting the CTI mission
• Provide intelligence-driven support to incident response investigations
• Develop training and awareness programs that improve the organization's understanding of threats

Lead Analyst, Cyber Threat Intelligence

Business Development Rep

• Responsible for overseeing all transactions across all stages of development (discovery, preclinical, clinical, commercial, etc.)
• Lead deal teams and collaborate with cross-functional teams to maximize transaction success
• Coaches and oversees Senior Directors on the Transactions team
• Partners with the TA Search & Evaluation team to identify and evaluate external opportunities
• Influences senior leadership, internal stakeholders and external partners on key decisions
• Lead large-scale company business development initiatives

Associate Vice President – Transactions and M&A – Corporate Business Development

General Counsel

• Provide strategic, solutions-oriented legal counsel and pharmacovigilance subject matter expertise in support of Lilly’s broad portfolio of products
• Serve as the primary legal partner to the pharmacovigilance operations team, providing day-to-day counseling on case management, safety surveillance, safety contracting, vendor oversight, and post-market safety surveillance studies
• Provide legal advice and support to product level safety management teams, including assessment of emerging safety issues
• Partner with Regulatory Legal Team and other colleagues on clinical development matters where patient safety considerations intersect
• Support AI and automation initiatives across Global Patient Safety and Clinical Development
• Provide legal, regulatory, and GxP compliance counsel on PV Quality matters
• Maintain strong awareness of evolving pharmacovigilance and clinical development related laws, regulations, and guidance
• Influence internal and external customers on priority regulatory policy initiatives

Senior Director – Counsel, Integrated Patient Safety, Regulatory Legal

Director

• Engage in continuous learning to maintain the highest level of technical expertise within the therapeutic area.
• Establish themselves as a reliable, trusted resource of unbiased, accurate, up-to-date medical and scientific information.
• Spend the majority of time on customer-facing activities to deliver a positive customer experience.
• Connect SEs/CEs with other Lilly resources or internal business partners.
• Demonstrate strategic analysis, planning, and prioritization to maximize efficiency with territory ownership.
• Synthesize and communicate actionable customer/clinical insights to internal teams.

Associate Director – Medical Science Liaison, GI/Thoracic Oncology

Compliance

• Develop, Update and Execute the Global Regulatory Strategy - Initiate and Update Regulatory Strategy Document (RSD)
• Obtain input from the global regulatory team members to develop a global regulatory strategy which supports product (including delivery device and relevant medical devices) development, registration, and lifecycle maintenance globally
• Ensure regulatory strategy is integrated into the development team plan from Candidate Selection to End of Product Lifecyle (including NILEX)
• Develop and implement innovative approaches and solutions, and drive acceleration strategies
• Identify and effectively communicate regulatory risks
• Lead Global Regulatory Team in the development of RSD(s) for assigned programs
• Initiate and maintain regulatory strategy documents by leveraging team expertise, as well as scientific, drug/device clinical development and knowledge from health authorities such as regulatory policies, regulatory precedents, trends, and emerging regulatory science
• Integrate information from the external environment, product specific regulator advice, and other public information (i.e. Advisory Committees) to develop robust, innovative regulatory strategies and solutions
• Provide input for and attend key regulatory agency meetings, as needed, that could impact the global product strategy or brand
• Enable discussion of the RSD and regulatory issues/challenges at the Regulatory Strategy Forum together with Global Regulatory Team
• Continually expand therapeutic area knowledge
• Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment
• Monitor upcoming and recent approvals of competitive development programs/plans
• Ensure strategic messaging and content of global regulatory submission documents
• Provide regulatory direction in the development of the core data sheet and claims mapping to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent
• Ensures local strategies and solution deliver to the global regulatory strategy and meets BU and brand goals
• Provide timely and effective communication updates to the GBD teams and BU management and other internal stakeholders, as appropriate
• Lead Global Regulatory Team consisting of regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD & E, and GRA-Global Labeling and Product Communications
• Ensures clear and transparent two-way communication between GBD/global program team and Global Regulatory Team
• Coach and facilitate a feedback culture within the Global Regulatory Team to develop team performance
• Communicate and share key information to enable seamless execution of global regulatory strategy and cross-functional shared learnings
• Represent Regulatory on the GBD/Global Program Team Support development teams in strategic planning, trial design and registration strategies for all in-scope countries for assigned products/programs, bringing in regional, CMC and Device regulatory scientists as needed
• Consistently communicate well defined, successful regulatory strategies throughout the organization
• For Preclinical and Early Clinical Development Programs: Lead and develop the US strategy for submission and amendments for IND and IDE
• Determine and communicate submission and approval requirements and regulator expectations
• Generate regulatory documents and ensure the regulatory documents contain appropriate data/information based on regulator expectations and are clearly written to articulate Lilly’s scientific position
• Anticipate, resolve, and communicate key technical, operational, and strategic issues that may impact other development functions or the development team
• Propose innovative solutions to regulatory issues to meet the business objectives while maintaining compliance with applicable regulations and internal quality systems
• Own relationship and interaction strategy with US FDA
• Execute high quality communications with FDA and internal stakeholders to articulate and ensure understanding of the regulatory strategy and complex issues
• Accountable for communications to the regulator, development teams, GRA, other development functions, Research, and BU leadership.
• Engage in, influence, and shape external environment initiatives related to portfolio assets
• Creates and fosters strategic relationship with key external players to identify and anticipate opportunities for growth
• Review corporate communications press releases
• Set appropriate direction with Global Marketing and GBD team for development, review, and approval of promotional claims
• Partner with Regulatory Product Communications reviewer to advise GBD team on promotional strategy
• Partner with Regulatory Product Communications reviewer to review and approve press materials and IR communications
• Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, and Deliver in internal and external interactions
• Model the innovation, leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers
• Participate in forums that share regulatory information across GRA components and other Lilly teams and business partners
• Constructively challenge teams to reach the best solutions to issues
• Serve as a mentor for GRA personnel

Senior Director – Global Regulatory Lead, Oncology

• Managing the activities of TS/MS and ENG personnel supporting the oversight of external manufacture of dry products
• Balancing coaching a technical and engineering staff
• Implementation of technical projects, technical transfers, commercialization, process optimizations and engineering activities oversight
• Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc.
• Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits
• Ensure appropriate technical and Engineering oversight and stewardship of oral solid dose form manufacturing and packaging

Associate Director – TSMS Dry External Manufacturing

Operations

• Provide leadership and direct management to the process operators in the Medicine Foundry operations group
• Ensure the safety and quality of products and compliance of equipment and buildings
• Assist in delivering the production schedule and supervise process operators
• Provide initial management responses to events and manage employee relations for all shift personnel
• Share responsibility for meeting production targets
• Enforce adherence to compliance requirements (safety, quality, and environmental)
• Oversee operation of processes and equipment according to batch records
• Monitor, test, clean, and operate area equipment and systems
• Lead by example and promote accountability at all levels
• Provide technical leadership for troubleshooting and reaction to process upsets
• Follow procedures for safety and quality event reporting and documentation
• Oversee communication between shifts regarding the status of operations
• Participate in daily shift huddles/meetings to understand daily operational goals
• Lead assignments for building and area operations
• Responsible for effective deployment of operators to meet production schedules
• Manage individuals’ performance on shift and ensure shift members are appropriately trained
• Partner with area Associate Director to understand Foundry strategy

Supervisor, Biologics Operations

Research Scientist

• responsible with facilitating the transfer of chemical processes, under appropriate supervisory guidance, from development laboratories to pilot plant operations (including kilo-scale or pilot-scale production)
• Operate and troubleshoot kilo-scale equipment including multi-purpose reactors, filtration systems, drying equipment (including AFD and tray dryer)
• Apply chemical engineering principles (heat/mass transfer, reaction kinetics, thermodynamics, fluid dynamics) to scale-up calculations and equipment sizing.
• Develop and apply appropriate cake filtration models to predict filtration rate, cake resistance, and deliquoring performance.
• Design and execute filtration wash studies.
• Apply appropriate modeling or semi-empirical approaches to predict and control particle size distribution (PSD) during crystallization.
• Actively involved in receiving chemical process from early phase process research and development labs and evaluating the safety of the incoming procedures in collaboration with the chemist and safety group.
• Author, review technical documents, including standard operating procedures (SOPs), batch records, campaign summary reports, and deviation reports.
• Perform and document Definitive Lab Trials of crystallization step to confirm plant readiness.
• Perform familiarization reactions to ensure plant readiness of process steps with focus on crystallization and filtration at the Lilly Medicine Foundry.
• Ordering and staging process-related GMP consumables and equipment parts for kilolab runs.
• Efficient with summarizing and presenting experimental results and challenges.
• Analyze data to make fact-based decisions.
• Maintain a well-organized and detailed lab notebook to enable the preparation of technical packages/technical transfers and accurate replication in receiving labs.
• Apply scientific knowledge to identify areas for improvement and implement new technologies or procedures.

Principal Scientist – Process Translation and Execution

• Provide leading researchers and practitioners with scientific and clinical knowledge
• Address clinical care gaps for their patients
• Clarify nuanced clinical or research questions
• Synthesize the latest research on products, disease states and standard of care for specific indications and therapeutic areas (TAs)
• Establish oneself as a reliable, trusted resource of unbiased, accurate, up-to-date medical and scientific information
• Act as one of the primary interfaces between Lilly Medical and SEs/CEs to deliver a positive experience
• Connect SEs/CEs with other Lilly resources or internal business partners as appropriate
• Facilitate collaborative research opportunities
• Partner with clinical development in support of studies and investigators to accelerate the pipeline and evidence generation

Associate Director – Medical Science Liaison, Cardiometabolic Health

Medical Director

• Collaborate with discovery, translational medicine, and clinical teams to develop and refine therapeutic hypotheses for autoimmune and inflammatory diseases
• Participate in prioritization of target and modality selection, integrating scientific rigor with clinical feasibility, unmet needs, and commercial potential, with particular attention to transformational potential of proposed programs
• Evaluate and diligence external discovery and early clinical opportunities for potential partnerships or acquisitions
• Provide scientific and clinical expertise to portfolio strategy to ensure a robust pipeline of transformational medicines in autoimmunity and inflammation
• Act as a visible strategic leader within the immunology portfolio, influencing direction, investment decisions, and development priorities
• Design early clinical studies that efficiently test therapeutic hypotheses
• Collaborate with clinical pharmacology, biostatistics, regulatory affairs, operations, and other stakeholders to optimize study design and execution
• Integrate translational endpoints and biomarker strategies to accelerate and maximize learning from early clinical studies and enable early decision-making
• Contribute to regulatory interactions, including pre-IND, IND submissions, interactions to ex-US health authorities, as well as regulatory strategy development
• Monitor patient safety and ensure compliance with GCP, FDA, ICH guidelines, and company policies
• Drive innovative experimental medicine approaches and accelerate progression from first-in-human through proof-of-concept
• Serve as scientific and medical expert across multiple therapeutic programs simultaneously
• Lead early clinical strategy in cross-functional teams through matrix influence, aligning diverse stakeholders around common objectives
• Facilitate decision-making processes across discovery, development, and commercial functions
• Mentor and develop junior team members while building scientific capabilities across the organization
• Operate as a culture-shaping leader who elevates performance, accountability, and collaboration across teams
• Establish and maintain relationships with key opinion leaders and scientific experts in autoimmunity and inflammation
• Represent Lilly at scientific conferences, advisory boards, and industry forums
• Support business development activities through clinical scientific due diligence
• As appropriate, identify, evaluate, and execute strategic partnerships with CROs, biotech companies, academic institutions, and research organizations to enable the discovery and early development portfolio and strategy
• Enhance Lilly’s external scientific presence as a thought partner and collaborator in immunology innovation
• Partner with regulatory colleagues on IND strategy, FDA interactions, and global development planning
• Contribute medical expertise to regulatory submissions and agency communications
• 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 immunology assets

Executive Medical Director – Early Clinical Development, Immunology

• Serve as the senior operational and strategic leader accountable for the end-to-end process and systems architecture applied by Exploratory Medicine and Pharmacology (EMP)
• Ensure that Exploratory Medicine and Pharmacology (EMP) can deliver its clinical portfolio compliantly and efficiently through external vendors and CRO partners
• Act as the primary process and systems connection point between CDC and CTF
• Own the process architecture that enables EMP to deliver clinical studies through CRO and TPO partners in full compliance with Lilly's quality systems and regulatory obligations
• Own EMP's strategic integration framework for acquisitions and licensing deals
• Serve as EMP's primary point of accountability for inspection readiness relating to externally-delivered activities

Senior Director, Clinical Delivery Capabilities – Process, Systems and Strategic Integration

• Provide leadership and direct management to process operators in the Medicine Foundry operations group
• Oversee safety and quality of products and compliance of rigs and buildings
• Supervise process operators in the Lilly Medicine Foundry business
• Manage employee relations for all shift personnel
• Ensure adherence to compliance requirements (safety, quality, and environmental)
• Oversee operation of processes and equipment according to batch records, user manuals, design parameters, standard operating procedures, and work instructions
• Promote compliant operations and positive safety behaviors
• Provide technical leadership for troubleshooting and reaction to process upsets
• Participate in daily shift huddles/meetings to understand and set expectations for daily operational goals

Supervisor, Hybrid Operations

• Lead the continued development and maturation of the Cyber Threat Intelligence function
• Maintain personal technical proficiency in threat analysis, attribution, and intelligence tradecraft
• Direct the threat actor tracking and attribution program
• Lead the cyber threat intelligence components of brand and executive protection
• Develop and maintain strong working relationships with key partners across Cybersecurity, Corporate Security, HR, Legal, the Brand Office, Ethics & Compliance, and Tech@Lilly
• Strengthen Lilly's role as an active contributor in pharmaceutical-sector and cross-industry intelligence sharing communities
• Lead a team of cyber threat intelligence analysts
• Direct the evaluation, introduction, and integration of capabilities supporting the CTI mission
• Provide intelligence-driven support to incident response investigations
• Develop and deliver training and awareness programs that improve the organization's understanding of the external threat landscape

DevOps Engineer

• Provide engineering support to both maintenance and equipment owners in your area of expertise
• Ensure Maintenance program is appropriate for reliable operation of equipment
• Be a technical expert in the proper use of the CMMS for documenting equipment history
• Help ensure CMMS data accuracy and structure
• Determine spare parts identification and stocking strategy
• Ensure Job Plans are correct and contain sufficient detail
• Provide training to Maintenance personnel on new equipment, reliability principles & techniques
• Mentor process engineers and others on equipment reliability principles and processes
• Identify & support continuous improvement initiatives to enhance the Maintenance program in the short & medium term to maintain a reliable plant
• Participate, raise, investigate & complete HSE & Quality observation/deviations write-ups as appropriate
• Analyze predictive & condition-based monitoring data to identify follow-up actions and prioritize implementation
• Utilize appropriate techniques and tools (RCA, RCM, failure analysis) to reduce equipment issues (downtime, deviations, health and safety and expenses)
• Ensure the local maintenance procedures are in line with Global Engineering Standard & Engineering Best Practices including developing, reviewing & owning Departmental SOP’s
• Determine equipment criticality based on business requirements around quality, health and safety, mechanical integrity, manufacturing capacity and financial impact
• Ensure proper equipment criticality ranking is maintained in the CMMS
• Ensure the correct application of predictive maintenance technologies across the site
• Own Lilly Medicine Foundry Preventative, Predictive and Corrective Maintenance programs
• Interact with original equipment manufacturers (OEMs), vendors, and regulatory bodies to keep up to date with upcoming changes, improvements, or new regulations that may affect equipment reliability

Reliability Engineer

Clinical Research

• The Clinical Research Lead (CRL) is a strategic, field-based scientific leader responsible for driving the execution of Lilly clinical trials through exceptional investigator engagement and site performance management.
• Accountable for the full spectrum of investigator engagement from identification and qualification through enrollment, and support database lock, and study closeout
• Serve as a clinical trial scientific ambassador, ensuring investigators deeply understand protocol intent, scientific rationale, and patient eligibility requirements
• Develop and sustain strategic, high-trust relationships with investigators that span trials and therapeutic areas
• Influence enrollment by co-creating tailored recruitment strategies aligned with site capabilities, patient population realities, and study objectives
• Proactively find opportunities to reach new patients, accelerate enrollment and increase impact at priority sites, including novel site models, community-based research initiatives etc
• Capture and elevate critical insights from sites to optimize feasibility, protocol design, and study conduct
• Lead site-level strategy and risk planning to ensure strong and predictable enrollment and data delivery
• Leverage performance metrics to anticipate issues, intervene decisively, and maintain momentum toward clinical milestones
• Drive inspection readiness as a continuous discipline across sites
• Collaborate across functions and with vendor partners to resolve operational barriers, ensuring delivery with speed and quality
• Maintain advanced understanding of local treatment paradigms and standard of care to influence strategic country/site selection and protocol localization
• Provide oversight and quality assurance for vendor monitoring, escalating risks proactively
• Cultivate a portfolio of strategically aligned, high-impact investigators who consistently prioritize Lilly trials
• Enable an exceptional investigator experience by being a responsive, knowledgeable, and valued scientific partner
• Collaborate cross-functionally (e.g., Medical, Clinical, Study Delivery) to align on trial and site priorities, troubleshooting challenges with urgency and creativity
• Conduct data-informed site prospecting and prioritization, contributing to trial competitiveness and regional strategic execution
• Maintain scientific fluency and therapeutic expertise to lead meaningful, solutions-focused discussions with site personnel
• Act as a key liaison between field teams, vendors, and investigators, ensuring alignment, shared purpose, and continuous knowledge transfer
• Partner closely with field team colleagues to elevate the investigator and site experience, ensuring seamless collaboration and improving enrollment outcomes and Investigator relationships
• Represent Investigator Engagement with regulatory agencies, ethics committees, and national research organizations in countries/territory
• Influence the clinical trial ecosystem to improve regulatory agility and operational feasibility
• Ensure that local requirements are translated into compliant, efficient trial execution and that Lilly’s internal processes reflect evolving country landscapes
• Partner with leadership to identify and align regional initiatives and contribute to enterprise-wide clinical development success

Lead Analyst, Cyber Threat Intelligence

Associate Vice President – Transactions and M&A – Corporate Business Development

Senior Director – Counsel, Integrated Patient Safety, Regulatory Legal

Associate Director – Medical Science Liaison, GI/Thoracic Oncology

Senior Director – Global Regulatory Lead, Oncology

Associate Director – TSMS Dry External Manufacturing

Supervisor, Biologics Operations

Principal Scientist – Process Translation and Execution

Associate Director – Medical Science Liaison, Cardiometabolic Health

Executive Medical Director – Early Clinical Development, Immunology

Senior Director, Clinical Delivery Capabilities – Process, Systems and Strategic Integration

Supervisor, Hybrid Operations

Lead Analyst, Cyber Threat Intelligence

Reliability Engineer

Associate Director – Clinical Research Lead, Oncology