Eli Lilly and Company

General Counsel

• Draft and prosecute globally patent applications, primarily related to genetic medicines
• Participate and contribute to overall patent portfolio strategy
• Analyze risks and develop sound tactical strategies/approaches/solutions
• Advise teams and senior management about exclusivity, freedom to operate, contract management, and litigation risks
• Apply a continuous improvement approach by remaining well versed in global laws, court precedents, and regulations
• Prioritize and manage a variety of projects; lead task-directed teams
• Contribute to efficiency, collegiality, and collaboration

Senior Director – Patent Counsel, Genetic Medicines

Risk

• Provide strategic guidance to product-specific cross-functional teams on optimal risk minimization strategies
• Support all risk management and risk minimization activities for assigned products including development and maintenance of RMPs, ARMMs, and REMs ensuring configuration with overall product strategy
• Collaborate with other GPS functions for tracking and reporting on product-specific metrics related to risk minimization efficiency and compliance
• Lead as subject matter expert responsible for Risk Management strategies across therapeutic areas and globally in collaboration with cross-functional teams
• Guide clinical development teams on benefit-risk and risk management considerations during product development

Director – Risk Management Scientist, Global Patient Safety

QA Engineer

• Lead and manage quality aspects of external API manufacturing sites, including but not limited to batch record review, disposition, deviation management, and change control
• Conduct and/or participate in quality audits of external manufacturing sites to assess compliance with cGMP, regulatory expectations, and Eli Lilly's quality standards
• Review and approve quality-related documents, such as manufacturing master batch records, validation protocols and reports, stability data, and analytical methods
• Collaborate cross-functionally with internal teams (e.g., Supply Chain, Regulatory Affairs, Technical Services) and external manufacturing partners to resolve quality issues and drive continuous improvement
• Provide expert QA guidance and support during new product introductions and technology transfers to external manufacturers
• Develop, implement, and maintain quality agreements with external manufacturing organizations
• Investigate and troubleshoot complex quality incidents, deviations, and out-of-specification results, determining root causes and implementing effective corrective and preventive actions (CAPAs)
• Represent Eli Lilly's quality interests during regulatory inspections at external manufacturing sites
• Mentor and provide technical guidance to junior QA associates

Principal QA, API, External Manufacturing, Peptides

Operations

• The Supervisor provides leadership and direct management to the process operators in the Medicine Foundry operations group
• The Supervisor is the management representative on shift
• The Manufacturing Supervisor actively supports and oversees start-up activities to bring manufacturing equipment into service
• The Supervisor leverages knowledge on their team and educates the team on the proper operation of the facility
• This role requires domestic and international travel to collaborate, train, and learn from sites that currently produce APIs
• Upon completion of the project phase, the Supervisor oversees the production of API molecules
• The Supervisor ensures the team consistently employs a safety-first, quality-always approach while managing a production process

Supervisor, Production Operations

Machine Learning Engineer

• Architect and implement privacy-preserving protocols for constructing representative test sets across distributed partner datasets, ensuring statistical validity while maintaining data isolation.
• Create comprehensive benchmark suites covering small molecules (ADMET, solubility, permeability), antibodies (affinity, stability, immunogenicity), and RNA therapeutics (stability, delivery, off-target effects).
• Develop validation strategies that assess model generalization across different experimental protocols, cell lines, species, and therapeutic indications while respecting partner data boundaries.
• Systematically benchmark federated models against public datasets (ChEMBL, PubChem, PDB, Therapeutic Antibody Database) to establish performance baselines and identify gaps.
• Implement time-split or proper scaffold-split validation protocols that assess model performance on prospective data, simulating real-world deployment scenarios and detecting concept drift.
• Build robust MLOps pipelines ensuring complete reproducibility of federated experiments, including versioning of data snapshots, model checkpoints, and hyperparameter configurations.
• Design statistically powered validation studies accounting for multiple testing, hierarchical data structures, and non-independent observations common in drug discovery datasets.
• Develop comprehensive performance profiling across diverse molecular scaffolds, target classes, and property ranges, identifying systematic biases and failure modes.
• Collaborate with engineering teams to integrate validation frameworks with the TuneLab federated learning platform built on NVIDIA FLARE, ensuring scalable and automated testing across partner networks.

Machine Learning Scientist – Federated Benchmarking, Validation Engineering

Director

• Provide leading researchers and practitioners with scientific and clinical knowledge
• Engage in scientific exchange to respond to diverse medical information needs
• Partner with clinical development in support of studies and investigators
• Analyze customer data, plan and prioritize to engage SEs/CEs effectively
• Communicate actionable customer/clinical insights to internal teams

Associate Director – Medical Science Liaison, Cardiometabolic Health

Manager

• Lead the cross-functional study team in the development and execution of clinical trials
• Utilize project management and scientific expertise to deliver trial(s) with quality, on time, and within scope and budget
• Monitor status and make changes as needed to meet trial deliverables
• Develop and track global milestones; assess, identify and monitor trial-level risks
• Manage relationships and serve as a single point of contact for trial communication
• Drive and coordinate local, regional and global study team throughout study implementation
• Be accountable for trial/regional enrollment strategy and execution
• Coach peers and team members on various aspects of clinical trial process
• Liaise with affiliates to understand local regulatory requirements

Senior Associate / Manager, Clinical Development Trial Lead

• Independently leads the cross-functional study team in the development and execution of complex clinical trials
• Responsible for delivering clinical milestones on trial(s) with quality, on time, and within scope and budget
• Monitor the status and make adjustments and changes as needed to meet trial deliverables
• Develop and track global trial enrollment plan by gaining alignment and integrating inputs across functions and geographies
• Assess, identify and monitor trial-level risks
• Create and monitor the budget grants and non-grants
• Lead and influence large, complex studies and/or multiple smaller studies
• Anticipate and resolve complex and key technical operational or business problems
• Leverage and demonstrate broad understanding of therapeutic, clinical drug development, and process expertise

Associate Director, Clinical Development Trial Lead

Clinical Research

• The CRP will be the clinical lead to progress multiple early clinical assets into first-in-human studies and support their further development through the conduct of clinical pharmacology and mechanistic studies.
• Contribute to the development of the overall strategy and clinical plan for clinical compounds.
• Collaborate with functional areas in the development of methods for assessing special clinical safety pharmacology studies.
• Design and oversee implementation of all clinical pharmacology studies.
• Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events.

Executive Director, Early Development Clinical Research Physician – Neuroscience

Systems Engineer

• Partner with the Process Translation and Analytical Laboratories functional areas and site, group, and global IT teams to implement and support digital laboratory solutions that enable the Foundry’s operational objectives
• Key lab systems include: Laboratory Information Management Systems (LIMS), Laboratory Execution Systems (LES), Electronic Lab Notebooks (ELN), Chromatography Data Systems (CDS), and Environmental Monitoring (EM) platforms
• Drive and support system design, configuration, validation, and release - serving as an IT subject matter expert (SME) for analytical laboratory IT systems at the Foundry
• Lead system design and configuration sessions with analytical lab SMEs for LIMS, LES, ELN, and CDS platforms, translating business and scientific processes into validated technical solutions
• Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols in compliance with 21 CFR Part 11 and EU Annex 11
• Manage data integrity requirements across lab systems and ensure audit readiness for regulatory inspections
• Coordinate instrument integration and data flows between lab equipment and LIMS/LES platforms
• Support site deployment and upgrade of analytical laboratory IT systems throughout the facility’s startup and operational phases
• Produce and maintain Computer System Validation (CSV) documentation, standard operating procedures (SOPs), and validation plans in alignment with applicable regulatory frameworks
• Ensure systems remain in a validated state and manage their lifecycle through releases, recapitalization, and retirement
• Collaborate with site and global IT system teams to ensure operational readiness of laboratory systems supporting the Foundry’s go-live objectives
• Support audits and provide oversight for management reviews, laboratory metrics, equipment records, and laboratory documentation.