Director, eClinical Data & Systems

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

Benefits offered by this job

401(k) match with company contribution

Medical, dental, and vision coverage

Life and disability insurance

Flexible spending accounts

Job summary

Exelixis in Alameda, CA, seeks a senior leader to oversee clinical and operational data systems across Phase I–IV trials. You will drive EDC governance, select vendors, and transform data capture technologies to improve trial efficiency.

The role requires extensive Biotech/pharma experience, strong GCP/ICH knowledge, and a track record in guiding regulatory submissions and large-scale data programs.

Qualifications

• Minimum of 13 years of related experience for BS/BA path; 11 years for MS/MA; 8 years for PhD.
• Experience in Biotech/Pharmaceutical industry is required.
• Experience in Oncology clinical trials is preferred.
• Experience leading major change initiatives is required.
• Experience participating in regulatory submissions and inspections is required.

Responsibilities

• Oversee, develops and manages clinical and operational data systems and infrastructure projects.
• Provide governance and oversight of EDC vendors and service providers.
• Lead continuous process improvement in data management and data standards.
• Develop training curricula for data management activities and SOPs.
• Direct supervision of employees with accountability for performance and staffing.

Skills

Clinical data management

Biotech/pharma experience

Oncology trials

GCP/ICH knowledge

EDC systems

Leadership/people management

Regulatory submissions

Education

BS/BA in related discipline

MS/MA in related discipline

PhD in related discipline

Certifications in data management

Tools

EDC platforms

CDISC standards

Job description

Exelixis in Alameda, CA, seeks a senior leader to oversee clinical and operational data systems across Phase I–IV trials. You will drive EDC governance, select vendors, and transform data capture technologies to improve trial efficiency.

The role requires extensive Biotech/pharma experience, strong GCP/ICH knowledge, and a track record in guiding regulatory submissions and large-scale data programs.