Purpose: The purpose of the Forward Development Lead role is to own the end-to-end delivery of validated computer system assets across the R&D Quality portfolio, from problem identification through production deployment, adoption, and sustained value realization, and to build a team of Forward Deployed Engineers (FDEs) who do the same. FDEs are hybrid technical practitioners embedded with the business, working at the intersection of software engineering, computer system validation, and customer-facing problem solving. In a GxP-regulated environment, this role uses Computer System Validation (CSV) procedures as a source of speed and business value, shaping scope, risk categorization, and validation strategy so that compliance accelerates outcomes rather than delaying them.
This role collaborates with members of the R&D Quality team, Tech[redacted] delivery partners, Business Quality Assurance (BQA), Computer Systems Quality Assurance (CSQA), and functional leaders across Research & Development at Lilly. The role is accountable for demonstrating value realization across an assigned asset portfolio while developing the next generation of FDEs within Lilly.
Primary Responsibilities- Owns the full lifecycle of an assigned portfolio of quality data and computer system assets, from concept and requirements through deployment, adoption, and sustained business outcomes; no handoffs that diffuse accountability.
- Authors product and system requirements, oversees translation of business problems into technical specifications and defines the measurable success criteria against which delivery is evaluated.
- Operates as a hands-on technical practitioner: reviews code, evaluates architecture decisions, quality-checks technical work, and directs internal and external delivery resources.
- Applies the CSV framework as a delivery accelerator, using GSOP-1201 and related artifacts to shape validation strategy in service of business outcomes.
- Builds and coaches a team of Forward Deployed Engineers, growing the pipeline of technical talent capable of operating at the intersection of business, technology, and quality.
- Tracks and reports value realization against defined metrics; accountable to the Results Management Office for outcome delivery.
- Partners with Tech[redacted], BQA, and CSQA to ensure enterprise alignment, validation compliance, and long-term sustainability of assets.
- Owns user enablement, adoption strategy, and change management coordination in partnership with OCM resources; success is measured by adoption and business outcomes, not deployment completion.
- Escalates and manages complex issues, ensuring they are well researched, understood, and resolved.
- Represents the R&D Quality FDE function in cross-functional forums, influencing technology and quality decisions across the organization.
Basic Qualifications:- Bachelor's degree or above in computer science, data analysis, analytics, informatics, life sciences, engineering, or related field.
- Minimum 5 years of experience in data sciences, product development, computer system delivery, or quality within the pharmaceutical or biotechnology industry, including at least 2 years in a leadership or senior technical capacity.
Additional Preferences:- Advanced degree preferred.
- Demonstrated experience owning products or capabilities end-to-end, from concept through adoption and value realization.
- Hands-on technical fluency: able to write and review code, understand data architectures, and evaluate technical trade-offs.
- Working knowledge of CSA, CSV, GxP requirements, and GAMP5; ability to use procedural frameworks to shape delivery strategy rather than treat them as gates.
- Working knowledge of AI/ML governance in regulated decision-making, including validation, drift, and lifecycle expectations.
- Track record of delivering LLM-based solutions in Clinical, R&D, or regulated Quality settings with measurable business impact (e.g., cycle time, cost, quality, adoption).
- Experience coaching or developing junior technical staff.
- Proficiency in scripting languages such as Python for data manipulation and automation.
- Familiarity with Microsoft Power Platform (Power Apps, Power BI, Power Automate) and enterprise data platforms.
- Experience with change management and user adoption strategies.
- Agile or product management experience.
- Strong ability to communicate technical concepts to both technical and non-technical stakeholders, including senior leadership.
- Prior experience in pharmaceutical R&D quality is a strong asset.
Additional Information:- 10% travel may be required.
- This is an onsite position based in Indianapolis, IN. This is not a remote role.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$126,000 - $204,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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