Senior Director, eClinical Solutions & Data Platforms

Exelixis

Alameda (CA)

On-site

USD 224,000 - 284,000

Full time

7 days ago
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Benefits offered by this job

401k with company contributions
Medical, dental & vision
Life and disability insurance
Discretionary annual bonus
Stock purchase plan
Paid time off
Holiday pay

Job summary

Exelixis in Alameda, CA seeks a senior leader to oversee, develop, and manage clinical data systems and EDC governance across Phase I–IV trials, collaborating with DSS, Clinical Operations, IT, and CROs. You will drive data standards, vendor governance, and strategic initiatives to optimize trial execution and resource use.

The role leads staff, ensures quality and regulatory compliance (CDISC, GCP/ICH), and guides process improvements with a focus on scalable, AI-enabled data capture and

Qualifications

  • 15+ years in data management or Biotech/Pharma settings.
  • Experience in oncology trials and regulatory submissions.
  • Strong leadership and people-management experience.

Responsibilities

  • Oversees data systems strategy and EDC governance.
  • Manages vendor evaluation, governance, and deployments.
  • Drives process improvements and data standards governance.
  • Ensures compliance with CDISC, GCP and ICH guidelines.

Skills

Leadership
Data Management
EDC Systems
GCP & ICH
CRO Management

Education

BS/BA in related field
MS/MA in related field
PhD in related field
Equivalent education/experience

Job description

Exelixis in Alameda, CA seeks a senior leader to oversee, develop, and manage clinical data systems and EDC governance across Phase I–IV trials, collaborating with DSS, Clinical Operations, IT, and CROs. You will drive data standards, vendor governance, and strategic initiatives to optimize trial execution and resource use.

The role leads staff, ensures quality and regulatory compliance (CDISC, GCP/ICH), and guides process improvements with a focus on scalable, AI-enabled data capture and

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