Associate Director, CTI - Development, Clinical Dev

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

CTI MD Tech@Lilly

Associate Director, CTI - Development, Clinical Dev

Management Level: M1  |  Job Family: Information Technology

About the Organization:

CTI - Development owns the digital capability that patients, sites and study teams meet first: consent and data capture, patient engagement, and the systems that get a study designed, started and set up. The portfolio spans Trial Capabilities, Clinical Experience and patient engagement, and AI & Analytics. The organization is mid-transformation, modernizing platforms and scaling AI and agentic use cases while operating under strict GxP/GCP, data integrity and inspection-readiness requirements.

Job Description:

The Associate Director, CTI - Development, Clinical Dev, leads a team of engineering, product and delivery professionals and owns delivery, technical direction and capability growth across the Trial Capabilities, Clinical Experience and AI & Analytics domains. The role sits where clinical process meets engineering: close enough to the build to lead a design review and challenge an architecture, fluent enough in trial execution to shape how a study team actually works. It owns the demand relationship with clinical development business owners, directs the partner teams delivering a material share of the work, manages allocated budget and contractor capacity against plan, and is expected to set the agenda for AI and agentic adoption rather than wait for direction on it. Hands-on technical experience is expected and non-negotiable: a practitioner who has built and shipped software and integrations directly, and who stays current enough to pressure-test an architecture or a build versus buy call. The role is scoped at the upper end of the band and is expected to grow into responsibility for broader teams as the portfolio expands.

Core Responsibilities :

Delivery Ownership

- Own delivery execution across the portfolio (scope, schedule, quality, dependencies, release readiness, production health) for clinical experience and patient engagement products (eConsent, ePRO/eCOA, patient portals and apps) and study start-up capabilities (site activation, study build, CTMS/eTMF integration).

- Run the standing delivery cadence of operational reviews, backlog grooming, planning cycles (e.g., PI Planning) and release governance as a single portfolio-wide rhythm, and apply product-management rigor to prioritization, scoring business value, technical debt, effort and risk explicitly and agreeing success measures before work starts.

- Define and implement the portfolio metrics framework: release predictability, defect escape, production reliability, study build and site activation cycle time, and adoption by sites, study teams and patients. Instrument it where stakeholders can see it, not inside a backlog tool.

- Identify and solve organizational and operational problems and technical challenges across the portfolio, from resourcing conflicts and scope ambiguity to cross-team dependencies, escalating only what falls outside established guidelines and doing so with a recommendation.

Technical Direction & Engineering Standards

- Set and defend the technical direction of the portfolio; review architecture and design, challenge weak decisions, and own standards for APIs, data contracts, interoperability (CDISC, HL7/FHIR) and reuse across clinical platforms.

- Own the architecture and design decisions for the portfolio's products, approve solution and integration designs, and run a design review cadence that catches problems before a release rather than after one.

- Raise the engineering bar on test automation, CI/CD, observability and the deliberate reduction of technical debt.

- Stay personally current: spend enough time in the code, the integrations and the production systems to judge an estimate, read a pull request and ask the questions only a practitioner asks.

AI & Agentic Transformation

- Define and land a 12 to 24 month vision for AI and agentic capability in study start-up and clinical experience: protocol and document intelligence, automated study build, site and patient-facing assistants. Make the business case for it.

- Find the use cases, prove them quickly at low cost, and take the ones that work through validation into production use with the evaluation, guardrails and human-in-the-loop design that requires.

- Build the team's AI fluency, make AI-assisted engineering the normal way of working, and partner with business owners to redesign clinical process rather than automate around it.

Resource, Budget & Vendor Management

- Forecast resource needs across the portfolio and manage allocated budget and contractor capacity within approved guidelines, including allocation, ramp-up and release decisions.

- Own vendor and partner delivery: define scope, outcomes and acceptance criteria, hold suppliers to the same engineering, quality and GxP standards as internal teams, and manage performance on predictability and quality.

- Own SOW/MSA follow-ups, renewals and scope amendments, shape the sourcing mix for the portfolio, and protect institutional knowledge through documentation, code ownership and cross-training.

Business Stakeholder Engagement

- Act as the technology partner for business owners and study teams: the person they call first, and the person who tells them when an idea will not work. Represent the portfolio externally with platform vendors, sites and industry forums, influencing partner roadmaps toward Lilly's needs.

- Run the demand relationship: capture and challenge incoming requests, agree priorities against capacity, and keep one honest view of the roadmap and what has been traded away. Contribute to the Clinical Dev business-area plan by translating the modernization roadmap into resourced delivery cycles.

- Translate clinical need into technical options, and constraint, risk and cost into language a business owner can act on, with no surprises at release.

People Leadership

- Hold management responsibility for the team, including hiring, onboarding, goal-setting and performance appraisals; hire for the capability the portfolio needs next, such as AI engineering, product thinking and clinical domain depth.

- Coach and develop through specific feedback, honest check-ins and a development plan each person recognises as their own; serve as career advisor and partner with HR on growth plans.

- Grow engineering craft, not only careers: use design and code review as teaching moments, and build shared practice across internal pods and partner teams so good patterns spread.

- Build bench strength and succession, remove single points of failure, and lead through senior engineers, technical leads and partner pod leads as the portfolio grows, setting direction for work executed beyond direct line management.

Quality, Compliance & Process Leadership

- Deliver in a GxP/GCP-regulated environment covering computer system validation, 21 CFR Part 11, data integrity, inspection and audit readiness; design for security and patient data privacy from the start; own incident response and the service levels agreed with study teams.

- Implement and refine a standard framework for backlog management, delivery governance and execution (Agile/Kanban, PI Planning), and own the portfolio-level leadership reporting cadence.

Required Skills and Expertise :

- 10+ years of relevant experience in technology delivery, engineering leadership or product/platform management, including 4+ years of people-leadership experience managing technical teams.

- Deep, current, hands-on engineering background: able to build, review and troubleshoot services, APIs and integrations, not solely credentialed from past roles. Fluency in at least one modern programming language and SQL, with working command of cloud platforms and integration patterns.

- Proven experience taking AI, machine learning or agentic solutions beyond proof of concept into governed production use.

- Experience managing vendor and contractor relationships, including SOW/MSA administration within established commercial guidelines, and forecasting resource needs against an allocated budget.

- Demonstrated success owning a senior business relationship: shaping demand, negotiating priorities and capacity, and holding credibility through difficult delivery news.

- Demonstrated experience defining delivery or product metrics frameworks that stakeholders actually use.

- Demonstrated success building and retaining a technical team: hiring engineers, coaching through design review, and keeping critical talent.

- Experience operating in regulated (GxP) environments, including computer system validation and inspection-readiness practices, with fluency in Agile/Kanban delivery and tooling (Jira, Confluence, ServiceNow or equivalent).

- Strong communication skills, translating technical trade-offs into business, clinical and regulatory language.

Preferred Skills:

- 4+ years supporting clinical development technology: study start-up, site activation, patient- or site-facing systems, or clinical data capture.

- Experience with Veeva Vault Clinical, Medidata or comparable clinical platforms, working knowledge of clinical data standards (CDISC CDASH/SDTM, HL7/FHIR), and exposure to decentralized or hybrid trial designs.

Education & Experience:

- Bachelor's degree in computer science, engineering or a related field (Master's preferred); Agile or PMP certification a plus.

- Demonstrated ownership of delivery for a portfolio or platform, shaping technical direction from direct engineering experience.

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.

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