Eli Lilly and Company

Director

• Lead the cross-functional study team in the development and execution of complex clinical trials
• Accountable regionally and globally to deliver clinical milestones on trial(s) with quality, on time, and within scope and budget
• Use project management skills to develop and execute local, regional, and/or global clinical trials
• Monitor trial status and make adjustments as needed to meet deliverables
• Develop and track global trial enrollment plan and provide consultation to CDTLs
• Assess, identify and monitor trial-level risks
• Understand and monitor trial-level budget components
• Function as point of contact for other CDTLs on their clinical team as needed regarding budget items
• Partner with other organizations to coordinate and actively participate in Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs)
• Act as point of accountability for the Trial Master File for assigned trials, ensuring inspection readiness

Associate Director, Clinical Development Trial Lead

Clinical Research

• Execute assigned components of the U.S. medical strategy in alignment with brand and portfolio priorities.
• Contribute to evidence generation initiatives by leading assigned workstreams or analyses and translating data into Medical Affairs insights.
• Develop, update, and deliver high-quality scientific communications with accountability for content accuracy and rigor.
• Engage externally with healthcare professionals and scientific stakeholders to conduct compliant scientific exchange and capture insights.
• Plan and deliver Advisory Boards and scientific interactions, including content development and synthesis of outcomes.
• Own assigned Medical Affairs materials through Medical/Legal/Regulatory (MLR) review and ensure compliance with governance requirements.

Medical Affairs Clinical Research Scientist – Cardiometabolic Health

QA Engineer

• Participate in creating and maintaining a safe work environment including leading/enabling safety efforts for the Quality team.
• Support cross-functional teams, facilitate decision making and drive progress.
• Foster a strong collaborative quality culture including maintaining open communications and promoting teamwork and employee participation in the work group and with cross-functional teams.
• Ensure compliance with applicable laws, regulations, and guidelines to support early phase GMP activities.
• Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.
• Influence and oversee Facility, Utility, Maintenance and Equipment (FUME) Qualification/Maintenance/Calibration programs.
• Facilitate decision making within the team under tight deadlines.
• Effectively communicate with internal and external stakeholders.

Associate, Quality Assurance, Process Manufacturing

QA Automation Engineer

• Supervise and lead the Hardware, I&C and Automation site support team, including completing performance reviews and development plans
• Responsible for the Automation Technology management to deliver Automation team milestones and projects
• Staffing, including recruiting, resource planning, and succession planning
• Process validation work coordination
• Review and monitor financial performance; commit to meeting targets
• Actively participate and support the Automation Engineering Operations and Training Program
• Develop Project, Program and Initiatives execution metrics with analytics team
• Demonstrate a commitment to environmental, health, and safety
• Identify, track, and report key indicators of functional performance
• Ensure team is operating in a state of compliance

Associate Director – Automation Engineering, Control System HW

Software Engineer

• Program and test data collection systems and associated data repository mappings for a trial or set of trials within a program using data standards library components
• Ensure data collection systems and data warehouse mappings are delivered accurately, efficiently and in alignment with study objectives
• Provide insights into study level deliverables (i.e. Data Management Plan, Project Plan, database, and observed datasets)
• Support submission, inspection and regulatory response activities
• Lead cross Business Unit/Therapeutic Area projects or programs with high complexity
• Opportunity to develop and tests new ideas and/or applies innovative solutions that add new value to the portfolio

Clinical eDC Study Build Programmer

• Oversee material/vendor management process ensuring compliance with Lilly Quality Standards and applicable regulatory requirements
• Work with supply chain, customer service, procurement, and warehouse operations to assess and approve materials and suppliers
• Manage programs, facilitate operational enhancements, and provide support for warehouse functions such as material receipt, sampling, and batch release
• Provide Quality oversight for the detailed design and quality processes related to materials and vendor management processes as well as warehouse operational readiness activities
• Participate in ensuring that the quality management system is established and adhered to for this area

Principal – Material Management Quality Assurance

• Provide automation support for one or more operating areas across site and/or for capital projects.
• Mentor process control team, including design, controls philosophy, implementation and commissioning.
• Develop and implement the Automation Engineering Project Plan.
• Technically lead and oversee the work of Site Area leads and System Integrator including Functional Requirements, Design Specifications, DCS Application Software, Test Specifications.
• Lead/ Participate in design reviews and DeltaV application software reviews.
• Lead a team of automation engineers supporting commissioning.
• Provide periodic status updates to Project Management.
• Devising functional requirements and process control strategies for control systems in collaboration with Process Engineering.
• DCS software design, coding/ configuration and testing (sequence logic, graphics, batch software etc.).
• Implementing and supporting electronic systems (such as plant historians) used to capture process automation related production data.
• Maintain the validated state of the site control systems in line with Lilly quality standards including the development and execution of validation strategies and associated documentation.
• Automation support for capital projects including new product introductions.
• Promoting the use of automation to improve productivity, operational efficiency and compliance.

Senior Principal Engineer – Automation Engineering, Laboratory and Analytical Equipment

• Provide automation support for one or more operating areas across site and/or for capital projects
• Provide Automation, Process Controls and Data Historian expertise and support historian systems operating areas across site
• Function as the main Data Architect to ensure proper data contextualization and democratization of operational data for compliance and data analytics
• Technically collaborate with Site Area leads and System Integrators
• Work with Engineering, Operations and many cross-functional groups to troubleshoot issues
• Develop standard operating procedures, work instructions and other job aids

Engineer – Automation Engineering, Historian Admin, Data Architect

Engineer

• Understands and complies with corporate, divisional, and departmental procedures, including good manufacturing practices, safety, and other applicable regulations, and participates in the establishment and maintenance of the Foundry's Quality systems
• Serves as the technical authority for equipment design and scale-up calculations across the Foundry's small molecule node
• Leading detailed engineering calculations, heat and mass transfer modeling, and equipment sizing to support the design of production suites for small molecule, peptide, oligonucleotide, and other new modality processes
• Performing and directing rig-fit assessments for incoming processes, using process simulation tools (e.g., DynoChem, Aspen)
• Providing expert guidance on the selection and design of reactor systems for a diverse range of chemistries
• Driving scale-up from laboratory and kilo lab to full pilot plant production
• Developing and maintaining manufacturing processes and control strategies for drug substance APIs

Advisor – Process Engineer

• Provide expert medical and scientific support to all aspects of the business
• Support for drugs in development, marketed products, and the disease state
• Engage with external stakeholders and identify evidence gaps
• Shape the scientific strategy and ensure impactful dissemination of data
• Lead and develop a team of 3-4 medical affairs professionals
• Foster a collaborative team environment
• Communicate up, down, and across the organization
• Shape breast cancer and PI3K strategy and execution plans

Senior/Executive Director, Clinical Research Physician – Breast Cancer, PI3K

Compliance

• Provide strategic, tactical and operational regulatory CMC leadership across therapeutic modalities and manufacturing technologies to expedite development of the small molecule portfolio.
• Support clinical trial applications, market registrations, and post approval submissions.
• Knowledge of global regulations, guidelines, and regulatory precedent coupled with deep technical knowledge of CMC development and manufacturing processes.
• Development and implementation of innovative regulatory strategies and platform approaches based on changes in external environment.
• Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product lifecycle planning.
• Lead preparation, critical review, and approval of CMC documents for global regulatory submissions and responses.
• Takes a proactive leadership role in the critical review of molecule specific CMC development and lifecycle strategies.
• Provide high quality, timely and clear regulatory advice to project teams.

Director, Global Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC), Platform Innovation – Small Molecules

• Source and evaluate external capabilities, technologies, and assets across all three pillars, drawing on your drug discovery expertise and understanding of LSMD's strategic needs
• Maintain a structured pipeline of external opportunities — including potential asset acquisitions, research collaborations, and discovery partnerships — with clear status tracking, strategic fit assessment, and next steps
• Build and sustain relationships across the biotech, venture capital, academic, and CRO ecosystems to surface opportunities aligned with LSMD's priorities
• Represent SM E&I at partnering events (JPM, BIO, BioEurope), venture showcases, and scientific conferences
• Lead cross-functional scientific due diligence by coordinating input from LSMD experts across medicinal chemistry, computational chemistry, automation, pharmacology, biophysics, and AI/ML
• Author structured evaluation reports, investment theses, and governance presentations for senior leadership
• Own and maintain a living competitive landscape across SM E&I's key technology domains — tracking partnership activity, asset licensing transactions, technology acquisitions, and emerging science that may shift LSMD's priorities
• Translate landscape intelligence into clear, actionable strategic recommendations for LSMD leadership
• Partner closely with Therapeutic Area Search & Evaluate teams, Lilly Research Labs, Lilly's venture ecosystem (Catalyze360), and Corporate BD to ensure portfolio coherence and execution quality

Director, Small Molecule External Innovation

Account Manager

• Build and maintain strong relationships with partners
• Serve as the primary point of contact for partners
• Develop and maintain thorough knowledge of digital solutions
• Act as an ambassador for outstanding customer experience
• Listen actively to gather insights
• Partner closely with the sales team
• Lead the implementation of partnership-related initiatives
• Maintain compliance and ethical standards.

National Partnership Manager, Platform Solutions

• Participate in the development, conduct and reporting of corporate/global clinical trials
• Understand and keep updated with the pre-clinical and clinical data relevant to the product(s)
• Collaborate with the appropriate leaders in the development and maintenance of clinical strategy
• Plan, collaborate on, and review the scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions
• Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events
• Participate in development and review of label changes and labeling modifications

Clinical Research Physician – Ophthalmology

Artificial Intelligence

• Drive drug discovery programs by developing and applying innovative AI/ML models.
• Collaborate closely with experimental scientists to connect computational predictions with lab experiments.
• Support hypothesis testing and help iterate between modeling and experimental results.
• Lead the development of scientific foundation models that integrate molecular design and biological data.
• Advance the field by publishing findings in top-tier venues and representing Lilly at the forefront of the global AI4Science community.
• Work with MLOps and Data Engineering partners to help transition research prototypes into scalable tools.