Clinical Data Management Director
Location: United States (On-site, Hybrid, or Remote options based on business needs)
Category: Clinical Data Management | Biometrics | Oncology | Leadership
Exelixis is seeking a Clinical Data Management (CDM) Director to provide strategic, operational, and scientific leadership across all global oncology clinical studies (Phase I–IV). This senior leader is responsible for overseeing CDM activities across diverse resourcing models, ensuring delivery of complete, accurate, and high-quality clinical databases. The role serves as a key contributor to the Data Science & Biometrics (DSB) organization and acts as a cross-functional leader driving clinical data quality, process excellence, and portfolio performance.
This position requires an established CDM expert with a proven track record of delivering global data management programs, driving operational excellence, and ensuring alignment with timelines, budgets, and regulatory expectations.
Lead CDM delivery for all oncology clinical trials across Phases I–IV, utilizing internal teams, functional service providers, and fully outsourced models with global oversight.
Align with Business, Functional, and Therapeutic Area leadership to define CDM strategies that support portfolio objectives.
Serve as a strategic partner to Product Development, Medical Affairs, and functional leaders to ensure high-quality CDM/DSB deliverables.
Manage workload distribution, resource planning, and vendor utilization to support efficient portfolio execution.
Provide strategic decision-making with direct impact on trial execution and program-level outcomes.
Lead or support CDM process optimization initiatives across the organization to enhance quality, productivity, and effectiveness.
Develop, refine, and implement CDM processes, guidelines, and innovative approaches to support evolving organizational needs.
Oversee adherence to data management standards, compliance requirements, and performance metrics across all studies.
Build a high-performing, value-driven environment aligned with Exelixis core values and customer-focused culture.
Required Education:
BS/BA and minimum 13 years relevant experience, or
MS/MA and minimum 11 years relevant experience, or
PhD and minimum 8 years relevant experience, or
Equivalent combination of education and experience.
Experience Required:
Typically 15+ years of clinical data management experience in the biotech or pharmaceutical industry.
Strong background in oncology clinical trials is preferred.
Extensive experience leading global CDM programs across multiple regions.
Experience contributing to regulatory submissions and participating in regulatory inspections.
Minimum 8 years of leadership experience in matrixed, cross-functional environments.
Deep knowledge of CDISC standards, GCP, ICH, and risk-based data management practices.
Proven experience managing CRO performance and data delivery.
Broad expertise in clinical data management principles, industry regulations, and global standards.
Ability to solve complex problems and develop innovative technical or operational solutions.
Strong understanding of clinical development processes and adjacent functions.
Excellent analytical, strategic thinking, and communication skills with the ability to influence stakeholders at all levels.
Ability to develop, maintain, and train teams on data management SOPs and governance frameworks.
Strong leadership capabilities with experience guiding teams toward organizational goals.
Demonstrated ability to build effective networks and drive cross-departmental alignment.
Works on complex, high-impact issues requiring independent judgment and evaluation of multiple variables.
Leads coordination across diverse internal and external groups to ensure unified data strategy and execution.
Responsible for major programs and initiatives with organizational visibility and influence.
Base Salary Range: USD $181,500 – $257,500 annually, adjusted based on geographic region, experience, and internal equity.
Comprehensive Total Rewards package including:
401(k) with company contributions
Medical, dental, and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus eligibility
Employee stock purchase program and long-term incentives
15 vacation days in the first year
17 paid holidays, including a winter shutdown
Up to 10 annual sick days
Exelixis is an Equal Opportunity Employer committed to an inclusive environment and does not discriminate on the basis of race, gender, age, nationality, religion, disability, veteran status or any protected category.
This job description outlines the general nature and level of responsibilities for this role and is not intended to be an exhaustive list of all duties, qualifications, or expectations associated with the position.
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Paris | Lyon |South Africa :
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