The Director, Clinical Data Transformation & Delivery will drive enterprise-wide transformation of Lilly s clinical data strategy, partnering with senior leaders to align global functions and deliver measurable business outcomes. This leader will champion talent development, diversity, and inclusion, and serve as a change agent for digital innovation. Representing Lilly externally, the Director will shape industry standards and best practices, ensuring Lilly remains at the forefront of clinical data excellence.
Roadmap influence & standards assurance
- Continuously scan the landscape (regulators, standards bodies, peer sponsors, vendors) and translate best practices into clear recommendations that shape Lilly s clinical tech strategy and roadmaps .
- Define and socialize standards first reference patterns (protocol digitization, data flow, metadata driven transformations, quality-by-design) for use by delivery teams and partners.
- Establish advisory guardrails (conformance principles, decision frameworks, interoperability guidance) to keep programs aligned with enterprise architecture and inspection readiness.
- Drive enterprise-wide transformation in clinical data strategy, ensuring alignment across global functions and geographies.
Shape industry standards
- Represent Lilly in relevant working groups/communities (e.g., CDISC, TransCelerate DDF/USDM, HL7/FHIR, DIA, SCDM ) and co create standards : contribute use cases, position papers, pilots, implementation guides, and public comments.
- Bring back clear adoption guidance (what s ready now vs. emerging), identify de risks, and propose pragmatic transition plans for programs and platforms.
- Partner with senior leaders to shape and execute Lilly s vision for digital clinical development.
- Represent Lilly as a thought leader in global industry forums, shaping the future of clinical data standards and practices.
Technical & regulatory advisory
- Advise on metadata driven SDTM/ADaM pipelines, document/analysis automation, and responsible AI patterns that improve quality, transparency, and cycle time.
- Recommend inspection ready controls (GxP, 21 CFR Part 11, Computer Software Assurance) and data protection practices appropriate for clinical data and documents.
- Develop, support and implement talent strategies to build a robust pipeline of future leaders in clinical data and technology.
- Translate technical innovation into measurable improvements in cycle time, data quality, regulatory compliance, and patient outcomes.
- Establish KPIs and metrics to track impact of transformation initiatives.
- Serve as a change agent, driving adoption of new standards, technologies, and ways of working across Lilly.
Hyderabad site delivery lead
- Serve as the Hyderabad clinical tech delivery lead , shaping ways of working with scaled delivery partners and suppliers; influence quality, budget discipline, and timelines through standards and guidance .
- Mentor and upskill engineers, analysts, and partner teams on standards first design, interoperability, and responsible AI.
What you ll bring
Must have qualifications
- 10+ years across clinical data/biometrics technology or standards spanning data collection, curation, transformation, and analysis.
- Deep, hands on knowledge of CDISC (SDTM, ADaM, Define XML) and working familiarity with USDM/DDF and ICH M11 .
- Demonstrated success advising strategy and shaping roadmaps in a global, regulated environment translating standards into actionable architecture and guardrails.
- Working understanding of cloud data platforms (e.g., AWS), APIs/integration, and metadata management; strong grasp of GxP/21 CFR Part 11/CSA expectations.
- Exceptional influence without authority , stakeholder engagement, and written/oral communication skills across technical and non technical audiences.
Preferred qualifications
- Experience participating in or leading workstreams with CDISC , TransCelerate DDF/USDM , HL7/FHIR , DIA , SCDM , or similar communities.
- Familiarity with Veeva Vault (CDMS/CTMS/eTMF), Medidata Rave/CDS , eCOA, and clinical labs data standards/terminology.
- Background with metadata driven SDTM/ADaM automation, code/lineage controls, and validation approaches.
- Practical insight into AI/ML and GenAI for clinical data quality, transformation, and content automation implemented with appropriate guardrails.
- Prior advisory engagement with scaled delivery centers or suppliers in India.
