Senior Director, Applied AI, Design & Innovation

Gilead Sciences•Foster City, CA

12d•Hybrid

About The Position

Design & Innovation is responsible for advancing the clinical trial experience through evidence-based decision-making, human-centered design, advanced analytics, digital capability development, and AI-enabled innovation. These approaches transform how programs and studies are designed, planned, and operationalized. The function supports patient-centric clinical trial design that provide enable more efficient execution through lean designs and less burden for patients and sites. The team has developed an industry leading set of capabilities that enable the organization to reliably predict the enrollment of the portfolio with a high degree of accuracy through modern statistical approaches, and we are developing the next generation platform to further enable even greater efficiency in the design and planning process capabilities. The Sr. Director, Applied AI will be responsible for leading the cross-functional design delivery team and is ultimately accountable for the overall operational strategy and study/site feasibility processes, systems, and people that support the entire portfolio across our three therapeutic areas of Virology, Oncology, and Inflammation. This role is also responsible for project leadership of Development level AI initiatives that aim to continue the development of our AI capabilities within the Design & Innovation scope and beyond to also include priority deliverables for Clinical Operations. This leader will report to and partner closely with the Executive Director to shape strategy, operating frameworks, and delivery models across a portfolio of initiatives within defined budgets and timelines. The role will lead the identification, development, integration, scaling, and value realization of innovative processes, technologies, data assets, and AI-enabled capabilities within Gilead’s clinical development model. This leader will serve as a strategic integrator across Clinical Operations, Clinical Development, Clinical Data Science, Regulatory, Medical Affairs, Commercial, and IT translating complex operational and clinical needs into coherent, realistic, and trackable innovation and AI strategies. The Sr. Director will help shape how innovation and AI capabilities are prioritized, governed, adopted, and scaled across Clinical Operations, with a focus on measurable business, operational, quality, and patient impact.

Requirements

Experience leading strategic and complex scientific, operational, and analytical initiatives that support program and study design including, but not limited to the execution of Bayesian inference models including Poisson-gamma, predictive enrollment scenario modeling, real-time enrollment performance monitoring
Demonstrated experience shaping and advancing AI, analytics, digital, or business transformation initiatives in a regulated environment
Strong understanding of how to evaluate AI and advanced analytics use cases for business impact, feasibility, scalability, adoption, and operational fit
Experience translating business, clinical, and operational needs into scalable technology, analytics, or AI-enabled solutions
Experience defining KPI, value, and ROI frameworks for innovation, digital, or AI initiatives
Experience leading or supporting portfolio governance, prioritization, and value realization for complex cross-functional initiatives
Experience supporting adoption of digital or AI-enabled capabilities through change management, stakeholder engagement, and scalable operating models
Understanding of data, platform, and integration considerations required to deploy digital and AI-enabled capabilities in a complex enterprise environment
High degree of customer focus and collaboration in a cross-functional team environment
Demonstrated planning, organizational, and large-scale budget management skills
Inspirational leadership style with the ability to attract talent, build high-performing teams, and influence across a complex matrix
Strong interpersonal skills, including the ability to lead, coach, and mentor staff and align multifunctional teams around informed risk-taking and data-driven decision-making
Advanced capabilities in change management and business transformation
Experience leading high-complexity cross-functional initiatives in life sciences, including strategic planning, governance, team management, and organizational alignment
Demonstrated ability to solve complex problems requiring strong judgment related to domestic and global regulations, guidelines, investigator interactions, and timelines
Excellent verbal and written communication skills, including experience presenting scientific, operational, and strategic concepts to executive audiences
Experience applying GDPR, HIPAA, information security, privacy, and vendor assessment requirements in the evaluation and implementation of new capabilities and technologies
Bachelor's degree with 14+ years of relevant scientific discipline such as Life Sciences, Information Technology, Computer Science, Pharmacy, Data Science, Business or related field OR 12+ years of relevant experience with an advanced degree or higher in Life Sciences, Information Technology, Computer Science, Medicine, Pharmacy, Data Science, Sociology, Public Health, Industrial Design, Marketing, Business, or related field.
Extensive working knowledge of drug development and global clinical trial conduct, including recent advances in data science, digital solutions, regulatory science, and AI-enabled technologies.
Prior experience leading organizational transformation and designing or executing large global programs and studies in program or clinical project management/clinical operations.
Extensive line management experience, which may include managing other people leaders, and a strong track record of hiring, managing, and developing diverse top talent.
Experience leading AI initiatives across multiple therapeutic areas (Oncology, Virology, Inflammation a plus)
Familiarity with MLOps, CI/CD, and AI Platform Architecture in Regulated (GxP) environments
Prior engagement with FDA, EMA, or industry consortia (e.g., TransCelerate, PhRMA, CDISC) on AI/digital innovation/clinical innovation.
Experience with agentic AI architectures, retrieval-augmented generation, and human-in-the-loop design patterns.
Track record of published thought leadership or external speaking on AI in clinical research.

Nice To Haves

Strategic clarity — you can translate ambiguous scientific and operational needs into a prioritized, measurable AI roadmap and support a team of strategic thinkers for enabling critical portfolio decision making and planning
Builder's mindset — you've stood up teams, capabilities, and platforms from scratch and scaled them
Bias for outcomes — you measure success in trial acceleration, cost reduction, and adoption, not models shipped
Collaborative leadership — you build trust with clinical, scientific, technical, and regulatory partners alike
Patient focus — you understand that every day saved on a trial timeline is a day earlier patients access therapies

Responsibilities

Define and own the multi-year Applied AI roadmap for Clinical Development & Operations, aligned to Gilead's enterprise AI strategy and portfolio priorities.
Build, scale, and lead a center-of-excellence team spanning data science, ML engineering, GenAI product development, and AI delivery management.
Establish governance, prioritization frameworks, KPIs, and ROI/value-realization models that quantify AI's impact at the trial, program, and portfolio level.
Serve as the executive voice of Applied AI to Senior Leadership, R&D governance forums, and external partners.
Lead development of predictive enrollment models that improve forecasting accuracy at the country, site, and study level.
Build real-time enrollment performance monitoring capabilities to enable earlier, more proactive interventions.
Partner with Clinical Operations and Program Management to integrate forecasting outputs into operational planning, resource demand, and budget cycles.
Drive AI/ML-enabled approaches to protocol design optimization , including eligibility criteria simulation, endpoint selection, and protocol complexity scoring.
Develop site selection and feasibility models leveraging internal data, external RWD/RWE, and historical performance signals.
Partner with Biostatistics and Clinical Development teams to embed AI insights into protocol authoring, design tollgates, and study start-up decisions.
Establish, refine, and drive a multi-year AI Innovation strategy aligned to Development and Clinical Operations priorities, operating model evolution, and enterprise AI direction.
Lead functional deliverables across Design & Innovation, design delivery, early and late-stage innovation capability development by providing overall operational excellence.
Lead the Clinical Intelligence team to support a variety of strategic queries and operational benchmarking for the executive Clinical Operations and Development leadership teams.
Shape and manage a portfolio of innovation and AI initiatives aligned to Clinical Operations strategy, business priorities, and value realization goals.
Identify, prioritize, and advance high-value innovation and AI use cases that improve clinical program and study design, operational planning, decision support, workflow efficiency, and stakeholder insight generation.
Champion integration of RWD/RWE into trial design, feasibility, and patient identification workflows.
Build partnerships with external data platforms and evaluate AI start-ups/vendors to access cutting-edge methodologies.
Recommend strategic partnerships, in-licensing, or build-vs-buy decisions to accelerate capability development.
Partner with Clinical Operations, Clinical Data Sciences, Biostatistics, Safety, Regulatory, and Digital to ensure AI solutions are designed for adoption, not just deployment.
Lead change management, training, and enablement to drive scaled adoption across study teams.
Represent Gilead externally with industry consortia, regulators (e.g., FDA), and strategic partners on Applied AI in clinical research.
Translate clinical and operational needs into actionable innovation and AI strategies, delivery plans, business cases, and measurable outcomes.
Partner with Clinical Development, Clinical Operations, Clinical Data Science (AI Research Center, Clinical & Development Systems, Biostatistics), Regulatory, Portfolio Strategy & Analytics, Medical Affairs, IT, Digital, and other stakeholders to translate innovation priorities into scalable capabilities and operating improvements.
Support governance and decision-making processes by preparing strategic recommendations, facilitating prioritization discussions, and communicating proposals, trade-offs, and decision options to senior stakeholder audiences.
Lead the development and governance of frameworks for identifying, testing, validating, integrating, scaling, and monitoring new capabilities across process, technology, data, analytics, and AI.
Define, develop, and track KPIs, value measures, and ROI frameworks to quantify the impact of innovation and AI capabilities at the study, program, and functional levels.
Establish governance standards for business cases, value tracking, adoption measures, scale-up criteria, and stop, pivot, or expand decisions across the innovation portfolio.
Help define fit-for-purpose operating, data, and platform requirements needed to support priority innovation and AI use cases across clinical development and operations.
Partner with Digital, IT, data science, and enterprise technology teams to support scalable architecture, integration, and deployment approaches for new capabilities.
Drive responsible implementation of AI-enabled capabilities with appropriate rigor around business value, adoption, usability, privacy, transparency, bias and risk management, compliance, and human-in-the-loop oversight.
Shape and operationalize an innovation portfolio that balances near-term business impact with longer-term capability building.
Strategically identify emerging external capabilities across start-ups, mid-sized organizations, and enterprise partners to accelerate innovation and create meaningful gains in speed, quality, and value.
Serve as a functional leader and liaison to key Development areas, aligning enterprise needs with practical capability development and deployment.
Act as an integrator across business, technology, and data teams to ensure alignment, visibility, accountability, and successful scale-up of priority capabilities.
Inform and influence corporate and regulatory policies and external guidance related to clinical development innovation, including patient-centricity, diversity, accessibility, decentralization, digital health, real-world evidence, and responsible use of AI.
Lead and support the creation of governance documents, procedural documentation, white papers, abstracts, presentations, manuscripts, and other thought leadership materials.
Promote awareness, adoption, and change management for innovation- and AI-enabled processes across the organization through playbooks, communications, training, and ongoing engagement.
Build organizational capability in innovation, digital, and AI-enabled ways of working by helping teams adopt new tools, practices, and decision models at scale.
Provide functional financial oversight, including latest estimates, resource planning, and communication across clinical and finance stakeholders.
Lead recruitment, development, and performance management for a team of full-time employees, contractors, and external partners.