Director, eClinical Solutions & Data Strategy

Exelixis Inc; Alameda (CA); On-site; USD 224,000 - 284,000; Full time

Benefits offered by this job

401k plan

Medical, dental, and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Employee stock purchase plan

Long-term incentives

Vacation days

Paid holidays

Sick leave

Job summary

Exelixis Inc. seeks a senior leader to oversee clinical and operational data systems across DSS, Clinical Operations, and IT. You will own EDC systems, evaluate vendors, and establish governance, ensuring efficient clinical trial execution and data standardization across Phase I–IV.

You will guide data management strategies, mentor staff, and drive process improvements, collaborating with cross-functional stakeholders to optimize automation and AI-enabled workflows.

Qualifications

• Typically requires advanced degree with extensive related experience.
• Experience in Biotech/Pharmaceutical industry is preferred.
• Experience leading major change initiatives and regulatory submissions is required.

Responsibilities

• Oversees and manages clinical and operational data systems and infrastructure-related projects.
• Provides business ownership of EDC systems, evaluates vendors and service providers.
• Leads governance of vendors and data standards, and develops standard eCRFs.
• Leads continuous process improvement in clinical data management.

Skills

Leadership

Data management

Regulatory knowledge

GCP/ICh

Stakeholder management

Education

BS/BA or higher in related discipline

MS/MA in related discipline

PhD in related discipline

Tools

EDC systems

Data standards (CDISC)

Job description

Exelixis Inc. seeks a senior leader to oversee clinical and operational data systems across DSS, Clinical Operations, and IT. You will own EDC systems, evaluate vendors, and establish governance, ensuring efficient clinical trial execution and data standardization across Phase I–IV.

You will guide data management strategies, mentor staff, and drive process improvements, collaborating with cross-functional stakeholders to optimize automation and AI-enabled workflows.