Associate Clinical Data Management Director

Overview

Lead Oncology Data Management for program‑level or multiple studies from start‑up through regulatory submission. Position located at Exelixis headquarters in Alameda, CA, with full relocation assistance.

• Serve as the primary point of contact for the Study Team and coordinate with cross‑functional members to meet project deliverables on time and to quality standards.
• Plan and execute all data management activities for assigned studies, ensuring development and archiving of Data Management study documents.
• Establish and lead the Data Working Group (DWG) for assigned study.
• Develop and maintain project timelines, tracking progress toward data deliverables through metrics and reporting.
• Identify, evaluate, and mitigate risks to data management deliverables.
• Resolve data‑handling related issues and provide expert guidance on eCRF/database design, data quality, and reporting to project team members and CROs.
• Develop and implement procedures for data quality review and acceptance prior to database lock or data analyses.
• Manage data transfers with CROs and third‑party sources, including SAE/AE reconciliation and MedDRA/WHO‑DD coding.
• Support transfer, locking, and archiving of study databases.
• Coordinate scheduling and time constraints across multiple projects.
• Recommend new or improved data‑management processes and data flow strategies.
• Collaborate with stakeholders to ensure project deliverables and timelines are met.
• Direct and oversee activities of Data Management staff assigned to studies and tasks within projects.
• Perform project‑level resource management in conjunction with CDM management.
• Lead electronic submission activities for data management as appropriate.
• Participate in selecting outsourcing partners, including input to RFPs, proposal reviews, audit participation, scope evaluation, vendor oversight, and training execution.
• Engage in CDM process‑improvement initiatives and advocate for CDM internally and externally.
• Hold junior data managers and data review teams accountable for performance.

• Bachelor’s/MPH or equivalent: minimum 11 years related experience;
  Master’s: minimum 9 years;
  PhD: minimum 5 years.
• Minimum 7 years of clinical data‑management experience in the pharmaceutical or clinical trial industry; at least 4 years in a project‑leadership role.
• Experience with Electronic Data Capture (EDC) required; experience with Interactive Voice or Web Response Systems (IVRS/IWRS) preferred.
• Demonstrated leadership of data‑management teams and project‑management skills.
• Strong problem‑solving, communication, and teamwork abilities.
• Knowledge of GCP, FDA regulations, and electronic data‑capture systems.
• Expertise with CDASH/CDISC standards preferred.
• Ability to develop and execute training, protocols, and procedures for data quality and safety monitoring.

• Base salary range: $163,000 – $231,000 annually (adjustable by geographic region).
• Exelixis Total Rewards program includes 401(k) with company match, group medical/dental/vision coverage, life and disability insurance, flexible spending accounts, discretionary annual bonus, and stock‑purchase opportunities.
• Paid time off: 15 days vacation (first year), 17 paid holidays (including company‑wide winter shutdown), up to 10 sick days per year.

The preceding job description provides a general overview of the role and is not a comprehensive inventory of all duties, responsibilities, and qualifications. Exelixis is an Equal Opportunity Employer and does not discriminate on the basis of race, color, sex, age, national origin, religion, sexual orientation, gender identity, veteran status, or disability. All employees and applicants are treated fairly under federal, state, and local law.