Executive Director, Clinical Data & Digital Strategy
About The Position
The Executive Director, Clinical Data & Digital Strategy manages and develops a high-performing team of managers and analysts, scaling 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. It oversees data and digital strategy in Development Sciences and works with IT, Quality, Programming, and Governance teams to define scalable, compliant data standards and digital solutions. The position defines the future-state digital ecosystem and leads product vision, roadmaps, investment priorities, business cases, and tradeoff decisions. It balances immediate launch and growth needs with long-term platform, data, integration, and lifecycle strategy, including roadmaps for scientific data platforms, metadata capabilities, knowledge systems, and AI-ready data assets. As part of the Digital Strategy, Analytics and Programming leadership team, it defines and implements procedures, guidelines, and policies for good programming practices. The role supervises employees directly and through subordinate supervisors, setting goals, conducting performance assessments, mentoring staff, and providing professional development. It partners with biostatisticians and clinical data management staff on clinical data collection, management, and reporting standards; defines training curricula; communicates progress and issues to department management; and promotes technical excellence, innovation, and scientific partnership. The role also supports continuous improvement and adherence to FDA regulations, GxP requirements, policies, standards, training records, guidelines, and SOPs.
Requirements
- BS/BA degree in a related discipline and a minimum of 18 years of related experience; or an MS/MA degree and a minimum of 16 years; or a PhD and a minimum of 15 years; 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 appropriate 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 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 Clinical Development.
- Work 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.
- Define, develop, and implement procedures, guidelines, and policies for good programming practices as part of the Digital Strategy, Analytics and Programming leadership team.
- 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 for departmental programming conventions and standards.
- Partner with biostatisticians and clinical data management staff to establish clinical data collection, management, and reporting standards.
- Communicate progress, milestones, and issues to department management.
- Perform other duties as assigned and comply with all policies and standards.
Benefits
- 401(k) plan with generous company contributions
- Group medical coverage
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- Flexible spending accounts
- Discretionary annual bonus program, or 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Executive
