Exelixis · 3 months ago
Clinical Data Management Director
Alameda, CA
Full-time
Onsite
Director/Executive
$182K/yr - $258K/yr
15+ years expExelixis is a biotech company focused on developing innovative cancer therapies. The Clinical Data Management Director is responsible for leading CDM activities across oncology clinical studies, ensuring data quality and compliance while overseeing resource allocation and cross-functional collaboration.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Key member of the CDM Team with accountability for delivery of all clinical trials Phase I to IV with a combination of internal FTEs (matrixed), Functional Sourcing Provider (FSP) or fully outsourced resources with a combination of on-shore and off-shore resources
Align with Business, Functional, and TA Heads/teams on key portfolio objectives and priorities to develop and influence the strategy and direction of CDM. Interacts with Produce Development & Medical Affairs colleagues, therapeutic or functional area leaders to execute on the organizational priorities, with a focus on quality CDM/DSB deliverables
Excellent organizational ability to manage CDM workload and ensure appropriate resource allocation is in place for optimal portfolio support. High level of vendor engagement/utilization
Decision-making has direct impact on the direction and effectiveness of the study as well as the portfolio level due to the scope and span of area of responsibility
Provide a leadership role in department process development and optimization of related clinical research activities. Lead or support the initiatives to drive change within CDM/BSD as well as across PDMA from a clinical data perspective
Align processes and priorities across the portfolio to maximize organizational effectiveness; design and implement innovative approaches to enhance productivity and effectiveness. Work with leadership to ensure the department strategy and processes are clear towards all stakeholders with optimal communication and engagement
Contributes to development and analysis of performance metrics and identifies ways to raise standards at the study as well as department level. Responsible for study team adherence to standards and compliance
Strong customer focus and belief in Exelixis values; creates a positive value-based work environment for the CDM department
Qualification
Required
BS/BA degree in related discipline and a minimum of 13 years of related experience; or
MS/MA degree in related discipline and a minimum of 11 years of related experience; or
PhD in related discipline and a minimum of 8 years of related experience, or
Equivalent combination of education and experience
May require certification in assigned area
Typically requires a minimum of 15 years of related experience and/or combination of experience and education/training
Experience in Biotech/Pharmaceutical industry required
Demonstrated experience leading global data management activities is required
Experience participating in regulatory submissions and inspections is required
A minimum of 8 years of leading teams in a highly matrixed organization
Excellent understanding of clinical development, quality and regulatory standards (e.g., CDISC) and policies relevant to Data Management and risk based data management approach of clinical data (e.g., GCP, ICH)
Has extensive experience in relevant industry/profession
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways
Develops technical and/or business solutions to moderate complex problems
Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results
Guides the successful completion of major programs, projects and/or functions
Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing
Has complete understanding and wide application of technical principles, theories, concepts and techniques
Has strong knowledge of other related disciplines
Applies strong analytical and business communication skills
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 of Clinical Research Organizations (CROs)
Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles
Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results
Creates formal networks involving coordination among groups
Preferred
Experience in Oncology clinical trials is preferred
Experience leading 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
The Motley Fool
2026-01-09
2026-01-08
Company data provided by crunchbase