Executive Director, Clinical Data & Digital Strategy

Exelixis•Alameda, CA

1d•Onsite

About The Position

The Executive Director, Clinical Data & Digital Strategy, manages and develops a high-performing data and digital strategy team of managers and analysts, scaling its capabilities as the organization evolves. The role establishes standards and architectural principles for data modeling, metadata management, semantic interoperability, ontology governance, and FAIR data implementation across Clinical Development. The position oversees data and digital strategy in Development Sciences and partners with IT, Quality, Programming, Governance, biostatistics, and clinical data management teams to define scalable, compliant data standards and digital solutions. It defines the future-state digital ecosystem and leads product vision, roadmaps, investment priorities, business cases, and tradeoff decisions, balancing near-term launch and growth needs with long-term platform, data, integration, and lifecycle strategy. The role also develops roadmaps for scientific data platforms, metadata capabilities, knowledge systems, and AI-ready data assets. As a member of the Digital Strategy, Analytics and Programming leadership team, the Executive Director helps define and implement procedures, guidelines, and policies for good programming practices. The role is responsible for staff goals, performance assessments, mentoring, and professional development; defining training curricula for employees and contractors; complying with FDA regulations for training records, guidelines, and SOPs; and continually improving processes, effectiveness, efficiency, communication, and compliance. The position fosters technical excellence, innovation, and scientific partnership, and communicates progress, milestones, and issues to department management. Other duties may be assigned, and the employee must comply with all policies and standards. The position is based in Alameda, California. The office is described as a modern, collaborative space; equipment provided includes dual monitors and ergonomic chairs. Travel may be required at 5%.

Requirements

BS/BA in a related discipline and at least 18 years of related experience; or MS/MA in a related discipline and at least 16 years of related experience; or PhD in a related discipline and at least 15 years of related experience; or an equivalent combination of education and experience.
Experience in the biotechnology or pharmaceutical industry.
Expertise with Databricks, Spark, Delta Lake, vector databases, and cloud-native data platforms.
Experience writing code in R and Python.
Experience recruiting, hiring, and supervising analysts.
Experience authoring SOPs and work instructions.
Good managerial and organizational skills.
Good written and verbal communication skills.
Knowledge of applicable FDA regulations, industry standards, and guidance documents.
Understanding of the clinical research process, trial designs, and development of protocols and analysis plans.
Proficiency in computer skills relevant to data and digital strategy, data lakes, semantic layers, and analytics platforms.
Knowledge of FDA GxP compliance and qualification.

Nice To Haves

Experience in oncology and Phase I–III studies is highly desirable.
Experience enabling machine learning, generative AI, retrieval architecture, and agentic systems through modern data architecture.

Responsibilities

Oversee all aspects of data and digital strategy in Development Sciences.
Manage and develop a high-performing team of managers and analysts, scaling capabilities as the organization evolves.
Establish standards and architectural principles for data modeling, metadata management, semantic interoperability, ontology governance, and FAIR data implementation across Clinical Development.
Partner with IT, Quality, Programming, and Governance teams to define scalable and compliant data standards and digital solutions.
Define the future-state digital ecosystem and lead product vision, roadmaps, investment priorities, business cases, and tradeoff decisions.
Balance near-term launch and growth needs with long-term platform, data, integration, and lifecycle strategy.
Develop roadmaps for scientific data platforms, metadata capabilities, knowledge systems, and AI-ready data assets.
Set employee goals, conduct performance assessments, mentor staff, and provide professional development opportunities.
As part of the Digital Strategy, Analytics and Programming leadership team, define, develop, and implement procedures, guidelines, and policies for good programming practices.
Adhere to FDA regulations regarding training records, guidelines, and SOPs.
Create or modify processes to improve effectiveness, efficiency, communication, or compliance.
Foster a culture of technical excellence, innovation, and scientific partnership.
Define training curricula for new employees and contractors, particularly departmental programming conventions and standards.
Partner with biostatisticians and clinical data management staff to establish clinical data collection, management, and/or data reporting standards.
Communicate progress, milestones, and issues to department management.
Perform other duties as assigned and comply with all policies and standards.
Directly supervise employees and supervise through subordinate supervisors.

Benefits

401(k) plan with generous company contributions.
Group medical coverage.
Dental coverage.
Vision coverage.
Life insurance.
Disability insurance.
Flexible spending accounts.
Eligibility for a discretionary annual bonus program, or a sales-based incentive plan for field sales staff.
Opportunity to purchase company stock.
Long-term incentives.
15 accrued vacation days in the first year.
17 paid holidays, including a company-wide winter shutdown in December.
Up to 10 sick days throughout the calendar year.