Clinical Operations Compliance Director – Biotechnology Oncology

Exelixis

. Ensure oncology clinical research activities comply with ICH GCP, applicable international and local regulations, industry standards, and Exelixis policies and procedures .

Posted 10/16/2026full-timeRemote • United StatesLead💰 $179,500 - $256,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in oncology clinical research compliance, including ICH GCP and biopharmaceutical regulations. Proven ability to lead risk management strategies, oversee CAPAs, and foster a culture of quality and inspection readiness across clinical operations.

Highest-signal resume keywords

Oncology Clinical Research ComplianceRisk Management StrategiesCAPA OversightBiopharmaceutical Industry RegulationsLeadership and Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Operations ComplianceRisk Assessment and MitigationQuality Metrics AnalysisInspection ReadinessProcess ImprovementData AnalysisRegulatory ComplianceCRO ManagementGCP StandardsStrategic Planning

Soft Skills

LeadershipCommunicationCollaborationProblem-SolvingAttention to Detail

Tools & Technologies

Microsoft ExcelMicrosoft WordMicrosoft PowerPointMicrosoft Outlook

Industry Keywords

Biotech IndustryPharmaceutical IndustryClinical TrialsQuality AssuranceRegulatory Inspections

About the role

Key responsibilities & impact

Ensure oncology clinical research activities comply with ICH GCP, applicable international and local regulations, industry standards, and Exelixis policies and procedures
Provide strategic and operational leadership for Clinical Operations compliance activities
Lead and continuously improve the Clinical Operations risk and issue management program
Identify, assess, mitigate and escalate risks affecting clinical trial quality, compliance and execution
Develop and implement functional risk management strategies and annual risk management plans
Review, analyze and communicate compliance trends, quality metrics, key risk indicators and inspection-readiness measures
Oversee CAPAs, including ownership, tracking, timely completion and effectiveness evaluation
Provide Clinical Operations leadership with updates and recommendations on CAPAs, compliance risks, trends and emerging issues
Collaborate with Quality Assurance on internal audits, regulatory inspections, inspection readiness and follow-up actions
Develop, implement and drive adoption of standardized processes, templates and best practices across studies
Facilitate resolution and escalation of significant operational and quality issues through governance structures
Oversee clinical vendors and CRO partnerships for quality and compliance adherence
Use operational and compliance data to identify process improvement and risk reduction opportunities
Serve as subject matter expert and provide guidance, training and consultation on Clinical Operations compliance processes
Foster a culture of quality, inspection readiness and proactive compliance management across R&D
Build standardized GCP and process training curricula, capability programs and quality metrics
Drive inspection readiness, TMF audit readiness, mock inspections, CAPA follow-up and BIMO/health authority inspection responses
Oversee monitoring quality, CRO performance, risk-based monitoring signals and escalation of site and data issues
Perform other duties as assigned and comply with policies and standards

Requirements

What you’ll need

Bachelor's degree in related discipline and a minimum of 13 years of related experience; or Master's degree in related discipline and a minimum of 11 years of related experience; or Doctoral degree in related discipline and a minimum of 8 years of related experience; or equivalent combination of education and experience
Experience in biotech/pharmaceutical industry required
Experience in biotech/pharmaceutical industry involving CROs, R&D outsourcing, purchasing or procurement roles required
Evidence of leadership and management skills in a relevant industry role involving strong engagement with external suppliers
Prior experience leading a team
Current understanding of the relevant external scientific, legal and regulatory environment
In-depth knowledge of biopharmaceutical industry regulations, standards and best practices
Leadership, networking, communication, engagement, partnership, collaboration and influencing skills
Ability to work independently with minimal supervision
Excellent analytical, strategic thinking, problem-solving, time management, change management and organizational skills
Strong interpersonal, verbal and written communication skills
Strong attention to detail
Ability to identify and communicate issues and risks
Excellent presentation skills
Ability to build and maintain strong relationships
Ability to influence without direct authority
Excellent computer skills, including advanced knowledge of Microsoft Excel, Word, PowerPoint and Outlook

Benefits

Comp & perks

401k plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Opportunity to purchase company stock
Long-term incentives
15 accrued vacation days in the first year
17 paid holidays including a company-wide winter shutdown in December
Up to 10 sick days throughout the calendar year
Necessary equipment, including dual monitors and ergonomic chairs
Disability accommodation during the recruiting process