Executive Director, Clinical Data & Digital Strategy

Exelixi

Alameda (CA)

On-site

USD 272,000 - 344,000

Full time

3 days ago
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Benefits offered by this job

401k plan with generous companyContrib
Medical, dental and vision coverage
Life and disability insurance
Stock purchase program
Discretionary annual bonus
Vacation days and holidays
Sick days

Job summary

Exelixis in Alameda, CA, seeks a senior leader to manage a team building data and digital strategy across the Clinical Development organization.

You will establish standards for data modeling, metadata, and FAIR data, guiding roadmaps, budgets, and tradeoffs while partnering with IT, QA, and governance teams to ensure scalable, compliant solutions.

Qualifications

  • Experience in Biotech/Pharmaceutical industries.
  • Proven leadership of data and digital strategy teams.
  • Knowledge of FDA GxP compliance and clinical data processes.
  • Expertise with modern data architectures and AI-ready data assets.

Responsibilities

  • Lead a high performing data and digital strategy team.
  • Define standards for data modeling, metadata, and interoperability.
  • Develop roadmaps and business cases for digital solutions.
  • Mentor staff and drive training and SOP development.
  • Partner with statisticians and data managers on standards.

Skills

Team leadership
Mentoring
Performance mgmt
Strong communication
FDA regulations
Data strategy

Education

BS/BA in related field
MS/MA in related field
PhD in related field
Equivalent combination

Tools

Databricks
Spark
Delta Lake
Vector databases
Cloud-native platforms
R
Python

Job description

SUMMARY/JOB PURPOSEManages 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/RESPONSIBILITIESResponsible 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 assignedComplies with all policies and standardsSUPERVISORY RESPONSIBILITIESDirectly supervises employee(s) and via other subordinate supervisors.EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIESEducationBS/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.ExperienceExperience 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 AbilitiesRequired: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 Requirements5% Some travel may be required#LI-JP1Location: 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: ApplicantAccommodations@exelixis.com.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.
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