Exelixis · 1 day ago
Associate Clinical Data Management Director (Biotechnology / Oncology)
Alameda, CA
Full-time
Onsite
Director/Executive
$160K/yr - $226K/yr
9+ years expExelixis is a biotechnology company focused on oncology, and they are seeking an Associate Clinical Data Management Director to oversee oncology data management activities at the program level. The role involves collaborating with cross-functional teams and external partners, leading data management activities, and supporting process improvement initiatives.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Jodie Donaldson
Responsibilities
As the main point of contact to Study Team, work collaboratively with cross-functional team members to meet project deliverables with quality and per agreed timelines
Lead the planning and execution of data management activities on assigned studies
Ensure all Data Management study documents are developed and archived
Establish and lead the Data Working Group (DWG) for assigned study
Develop and maintain Data Management timelines
Track and manage progress towards data deliverables through effective metrics tracking, analysis, and reporting
Effectively identify and mitigate risks to Data Management deliverables
Identify and resolve data handling related issues
Provide a high level of expertise in data management to support clinical studies
Provide clear verbal or written information and hands-on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database / data quality status
Develop and execute procedures for data quality review and data acceptance prior to data analyses and/or database lock
Manage data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA /WHO-DD coding
Support the transfer, locking, and archiving of study databases. Manage scheduling and time constraints across multiple projects
Prepare recommendations for new or improved processes for data management and data flow
Work collaboratively with cross-functional stakeholders to ensure project deliverables and timelines are met
Direct and oversees 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 for assigned studies including:
Input to Request for Proposal (RFP)
Review proposals
Participate in evaluation/audits and capabilities presentations
Review project scope of work documentation
Provide oversight of vendors providing Data Management services
Develop and execute study specific training of staff within a project
Lead or participate in CDM process improvement initiatives
Promote and be an advocate for CDM internally and externally
Direct the activities and hold accountable junior data managers and/or data review teams
Qualification
Required
BS/BA degree in related discipline and a minimum of 11 years of related experience; or
MS/MA degree in related discipline and a minimum of 9 years of related experience; or
PhD in related discipline and a minimum of 5 years of related experience; or
Equivalent combination of education and experience
May require certification in assigned area
Typically requires a minimum of 9 years of related experience and/or combination of experience and education/training
A minimum of 7 years of clinical data management experience is also required in the pharmaceutical industry or clinical trials
A minimum of 4 years in a project leadership role
Experience with Electronic Data Capture (EDC) is required
The ability to problem solve and have people/project leadership skills
Knowledge of GCP is essential
General knowledge of FDA regulations that govern the execution of clinical trials and Electronic Data Capture (EDC) systems required
Has extensive experience in relevant industry/profession and area of specialization
Uses professional concepts and company objectives to resolve complex issues in creative and effective ways
Identifies and implements methods and procedures to achieve results
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
Performs a variety of complicated tasks with a wide degree of creativity and latitude
Has complete understanding and wide application of technical principles, theories, concepts, and techniques
Has good general knowledge of other related disciplines
Applies strong analytical and business communication skills
Demonstrated Data Management Project Management skills
Excellent verbal and written communication skills and interpersonal skills are required
Preferred
Experience with Interactive Voice or Web Response Systems (IVRS/IWRS)
Demonstrated experience leading data management teams
Expertise in CDASH/CDISC standards
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
2026-01-07
Investor's Business Daily
2025-12-22
Company data provided by crunchbase