Job Description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

The role

Lilly is reimagining how clinical data is designed, transformed, and delivered--from our digital trial foundation to modern statistical compute. We're seeking a

Director?level leader

who brings deep

clinical data

and

technology

expertise and a passion for

industry standards

. You will

inform enterprise strategy and project roadmaps

with best practices from across the industry and

actively help shape the standards themselves

(e.g.,

USDM/Digital Data Flow (DDF), CDISC SDTM/ADaM/Define?XML, ICH M11, HL7/FHIR

).

Role Overview:

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.

Work model & travel

Hybrid

work from Hyderabad, India, collaborating across global time zones.

Travel

~10-20% (domestic + international), based on business needs.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.


Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


#WeAreLilly