Exelixis · 3 months ago
Executive Director, Clinical Data Acquisition
Alameda, CA
Full-time
Onsite
Director/Executive
$254K/yr - $361K/yr
18+ years expExelixis is a biotechnology company focused on developing innovative cancer therapies. They are seeking an Executive Director, Clinical Data Acquisition to lead a team in managing quality data collection activities across clinical studies, ensuring compliance and efficiency in data management processes.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Responsible for defining, and driving, the vision for optimized data collection that capitalizes on the latest technologies, is compliant with global regulatory requirements & guidances, and results in timely high quality clinical data generation
Ensure end-to-end management of all CDA activities including, but not limited to, company data standards, eCRF development, external data transfers/integration and reconciliation, and appropriately ensuring validation of clinical data systems and data repositories
Provide day-to-day leadership of the CDA team (employees, contractors, functional service providers) to instill a work ethic focused on proactive engagement and thought partnership with other roles in CDM and DSB, Information Technology, Strategic Sourcing & Procurement, Development Operations, Clinical Development, Global Patient Safety, and beyond
Maintain oversight of record retention strategies for clinical data and associated documentation in accordance with all applicable global regulations, company policies & procedures, and study-specific needs. This includes, but is not limited to, archival of clinical data at investigational sites, decommissioning of EDC systems, and contemporaneous storage of documentation in study-specific and/or system-specific document repositories (e.g. eTMF)
At the study and portfolio level, proactively drive quality, efficiency, and innovation to ensure data collection deliverables are met within the established timelines, budget, and quality/compliance standards (e.g. providing input to protocol design, database design, and validation, and data management plans, including data review strategies and data quality assurance)
Establish, and/or provide leadership in, governance structures working with relevant vendors including, but not limited to, data management vendor(s), sample management vendor(s), to ensure effective quality oversight of vendor deliverables and relationships supporting the company portfolio
Lead data standardization initiatives to ensure data collection methods comply with regulatory requirements, industry standards (e.g. CDISC), company policies & procedures, portfolio-level standards, and the practical needs of individual studies
Develop and implement a continuous process improvement strategy by monitoring key performance indicators, metrics, quality, and timeliness of study deliverables across the portfolio
Drives cross-functional senior leadership engagement to develop and deliver solutions for new service capabilities
Contribute to the development of departmental and study budgets, proactively managing budget, including accurate forecasting and cost accruals
Proactively identify and troubleshoot operational problems, issues, and obstacles, that help study teams to remove barriers to execution
Support study teams during submission, inspection, and other regulatory-related activities including, but not limited to, developing oversight processes, creating storyboards, presenting issues and mitigations
Strong customer focus and belief in Exelixis values; creating a positive value-based work environment for the CDA team. Able to lead, inspire and influence team/organization through rapidly changing business challenges
Stay current with regulatory and industry advances through cultivation of a wide external network. Able to represent Exelixis in data management, data strategy and other related capacities. Helps establish and maintain Exelixis CDM as an industry leader
May perform day-to-day tactical responsibilities to ensure successful execution of clinical studies across the company portfolio
Qualification
Required
BS/BA degree in related discipline and a minimum of 18 years of related experience; or
MS/MA degree in related discipline and a minimum of 16 years of related experience; or
PhD in related discipline and a minimum of 15 years of related experience; or
Equivalent combination of education and experience
May require certification in assigned area
Typically requires a minimum of 18 years of related experience and/or a combination of experience and education/training
Experience in Biotech/Pharmaceutical industry required
Demonstrated experience leading global data management and/or technical teams is required
Experience participating in regulatory submissions and inspections is required
A minimum of 12 years of line management experience is required
Excellent understanding of clinical development, quality and regulatory standards (e.g.CDISC) and policies relevant to data management (e.g. GCP, ICH)
Ability to identify, author, maintain and train staff on key data management SOPs and work-practice guidelines
Knowledge of Good Clinical Practices (GCP) is essential
Demonstrated success managing data management activities performed by external vendors
Preferred
Experience in Oncology clinical trials is preferred
Experience leading major change initiatives is preferred
Benefits
401k plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Sales-based incentive plan
Opportunity to purchase company stock
Receive long-term incentives
15 accrued vacation days in their first year
17 paid holidays including a company-wide winter shutdown in December
Up to 10 sick days throughout the calendar year
Company
Exelixis
Exelixis works is focused on discovering, developing and commercializing therapies for the treatment of cancer and other serious diseases.
1001-5000 employees
H1B Sponsorship
Exelixis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (39)
2024 (25)
2023 (25)
2022 (28)
2021 (29)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
$514MKey Investors
Deerfield
2015-07-23Post Ipo Equity· $135M
2012-02-16Post Ipo Equity· $65M
2010-06-03Post Ipo Debt· $160M
Leadership Team
Michael Morrissey
President and CEO
Christopher Senner
Executive Vice President and CFO
Recent News
2026-01-12
The Motley Fool
2026-01-09
Company data provided by crunchbase