Executive Director, Clinical Data & Digital Strategy

SUMMARY/JOB PURPOSE

Manages a team to build, develop and lead a high performing data and digital strategy 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 the Clinical Development organization.

ESSENTIAL DUTIES/RESPONSIBILITIES

• Responsible for oversight of all aspects of data and digital strategy in Development Sciences.
• Work closely 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 and mentor and provide professional development opportunities for staff.
• 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.
• Seeks continual improvement: creates or modifies processes to improve effectiveness, efficiency, communication or compliance.
• Foster a culture of technical excellence, innovation and scientific partnership.
• Define training curriculum 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.
• Performs other duties as assigned
• Complies with all policies and standards

SUPERVISORY RESPONSIBILITIES

• Directly supervises employee(s) and via other subordinate supervisors.

EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIES

Education

• BS/BA degree in related discipline and a minimum of 18 years of related experience; or,
• MS/MA degree in related discipline and a minimum of 16 years of related experience; or,
• PhD in related discipline and a minimum of 15 years of related experience; or,
• Equivalent combination of education and experience.

Experience

• Experience in the Biotech/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.
• Experience in oncology and study phases I - III studies highly desirable.
• Experience enabling machine learning, generative AI, retrieval architecture and agentic systems through modern data architecture.

Knowledge, Skills and Abilities

Required:

• Good managerial and organizational skills.
• Good written and verbal communication skills.
• Knowledge of appropriate FDA regulations, industry standards, and guidance documents.
• Understand the clinical research process, trial designs, and the development of protocols and analysis plans.
• Proficient in computer skills relevant to data and digital strategy, data lakes, semantic layers, and analytics platforms.
• Knowledge of FDA GxP compliance and qualification.

Travel Requirements

• 5% Some travel may be required

#LI-JP1

Location: Alameda, CA Range for this position: $272,000 - $344,000 The base pay offered will take into account job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

If you have a disability and need an accommodation in relation to the recruiting process, please email us at: [email protected].

WORKING CONDITIONS:

Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

DISCLAIMER: 
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.