This role provides strategic and operational regulatory CMC leadership to expedite the development of small molecule portfolios and support global market registrations. The incumbent will lead the preparation and review of CMC documentation for regulatory submissions and provide expert guidance to development teams.
The HEOR research scientist will develop and execute health outcomes research strategies to support drug development, access, and product differentiation within the oncology portfolio. They will lead cross-functional evidence planning and communicate complex scientific data to internal and external stakeholders.
The HEOR research scientist will develop and oversee health outcomes research strategies to support drug development and commercialization across the oncology portfolio. They are responsible for executing high-impact scientific studies and communicating findings to internal and external stakeholders to influence access and reimbursement decisions.
The HEOR research scientist leads the development and execution of health economic and real-world evidence strategies to support the oncology portfolio. They are responsible for managing a team of scientists, driving research dissemination, and influencing cross-functional business partners to achieve strategic goals.
The Senior Director will develop and execute legal strategies regarding litigation, policy engagement, and advocacy to support pharmaceutical innovation. They will manage complex litigation, government investigations, and disputes while providing counsel to various internal business functions.
The advisor will provide expert human factors engineering guidance for combination product development and lead usability research studies to ensure patient safety and regulatory compliance. They will also collaborate with cross-functional teams to integrate user-centered design principles into product requirements, documentation, and design evaluations.
The Senior Director will build and manage relationships with cancer patient advocacy organizations and professional medical societies to advance the Oncology Business Unit's strategic priorities. They will integrate patient and provider perspectives into clinical development, medical strategy, and evidence generation while collaborating with cross-functional teams.
The Associate Director leads the end-to-end negotiation and execution of consultation agreements between Lilly ExploR&D and external biotech partners. They are responsible for drafting, redlining, and managing a high volume of contracts while ensuring alignment with Lilly's R&D capabilities and governance standards.
The Advisor will lead the development and validation of in-house RLT analysis tools, including image reconstruction and dosimetry modeling for oncology research. They will also provide technical expertise in scanner qualification and performance characterization while ensuring regulatory alignment across clinical and preclinical workflows.
The Integrated Risk Data Engineer owns the data foundation for enterprise risk intelligence, designing and maintaining robust data pipelines and architecture. This role leads the integration of fragmented systems into a unified ecosystem to enable advanced analytics and predictive risk monitoring.
The Associate Vice President will establish and lead the global construction management and HSE organization, overseeing mega-capital projects from design through execution. This role is responsible for setting execution standards, managing EPC contractor performance, and ensuring safety, quality, and schedule adherence across the portfolio.
The Clinical Research Physician participates in the development, conduct, and reporting of global clinical trials to support product registration and commercialization. They serve as a scientific resource for study teams, ensuring compliance with regulatory standards and managing medical strategies for marketed compounds.
The role provides strategic, solutions-oriented legal counsel across a broad regulatory portfolio including drugs, devices, and diagnostics. Responsibilities include driving FDA regulatory engagement strategies and advising on regulatory aspects of acquisitions and asset transfers.
Lead the design and implementation of cloud-native data products and high-throughput pipelines to transform raw real-world data into analysis-ready assets. Manage the end-to-end lifecycle of RWD data products while collaborating with multi-functional teams to ensure scalability and regulatory compliance.
