Director, eClinical Solutions & EDC Leadership

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

Benefits offered by this job

401k plan

Medical insurance

Dental insurance

Vision insurance

Annual bonus

Job summary

Exelixis, Inc. in Alameda, CA is seeking a Director, eClinical Solutions (EDC Programming) to oversee and advance clinical data systems for Phase I–IV trials. You will lead governance of EDC vendors, drive data standards, and partner with Clinical Operations, IT and DSS to optimize trial execution.

Responsibilities include shaping strategy for data capture, mentoring staff, and ensuring compliance with GCP/ICH. Strong leadership and change-management experience are essential in this role.

Qualifications

• BS/BA degree in related discipline with extensive relevant experience.
• MS/MA degree in related discipline with substantial experience.
• PhD in related discipline with extensive experience.
• Equivalent combination of education and experience accepted.
• Certification in assigned area may be required.

Responsibilities

• Oversee and manage clinical and operational data systems and infrastructure projects across multiple trials.
• Provide Business Ownership of EDC systems; evaluate and select EDC vendors and service providers; establish governance.
• Develop strategies to transform data capture technologies and leverage AI/ML to optimize resource deployment.
• Support development and governance of Data Standards and standard eCRFs.
• Lead and develop staff; implement Continuous Process Improvement in Clinical Data Management.
• Ensure quality and timely completion of tasks by direct reports and manage multiple projects.

Skills

Leadership

Vendor governance

EDC systems

Data standards

GCP/ICH

Clinical data management

Regulatory submissions

Project management

Education

BS/BA degree in related discipline

MS/MA degree in related discipline

PhD in related discipline

Equivalent combination of education and experience

Certification in assigned area

Tools

CDISC

Job description

Exelixis, Inc. in Alameda, CA is seeking a Director, eClinical Solutions (EDC Programming) to oversee and advance clinical data systems for Phase I–IV trials. You will lead governance of EDC vendors, drive data standards, and partner with Clinical Operations, IT and DSS to optimize trial execution.

Responsibilities include shaping strategy for data capture, mentoring staff, and ensuring compliance with GCP/ICH. Strong leadership and change-management experience are essential in this role.