Associate Clinical Operations Compliance Director – Biotechnology Oncology

Exelixis

. Support the risk and issue management process for Clinical Operations .

Posted 10/16/2026full-timeRemote • United StatesLead💰 $168,500 - $238,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in risk and issue management within Clinical Operations, ensuring compliance with biopharmaceutical industry regulations and maintaining inspection readiness. Proficient in building quality metrics and training curricula while fostering collaboration across functional teams.

Highest-signal resume keywords

Risk Management StrategyCAPA ManagementBiopharmaceutical Industry RegulationsQuality Assurance LiaisonInspection Readiness

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Risk ManagementCAPA CompletionQuality Metrics DevelopmentGCP Training CurriculumMonitoring QualityData AnalysisRegulatory ComplianceInspection ResponseChange ManagementStrategic Thinking

Soft Skills

CollaborationProblem-SolvingAttention to DetailCommunication SkillsRelationship Building

Tools & Technologies

Microsoft ExcelMicrosoft WordMicrosoft PowerPointMicrosoft Outlook

Industry Keywords

Clinical OperationsBiotechPharmaceuticalGCPTMFBIMOHealth Authority InspectionsQuality AssuranceRisk-Based MonitoringInspection Readiness

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Support the risk and issue management process for Clinical Operations
Contribute to functional risk/issue management strategy and methodology
Assist in creating the annual functional risk management plan to ensure inspection readiness
Collaborate cross-functionally on risk management activities and escalate issues to appropriate governance
Support Clinical Operations CAPA owners, including owner assignment, follow-up and completion
Assist with updates on CAPA completion data
Act as liaison for Quality Assurance and other functional teams across R&D
Build standardized GCP and process training curriculum
Drive ongoing capability and knowledge sharing
Build and renew quality metrics to track progress and consistency across Clinical Operations
Drive continuous inspection readiness across studies
Keep TMF audit-ready and run mock inspections
Follow up on CAPAs and lead BIMO and health authority inspection response
Oversee monitoring quality and CRO performance
Oversee risk-based monitoring signals and timely escalation of site and data issues
Perform other duties as assigned
Comply with all policies and standards

Requirements

What you’ll need

Bachelor’s degree in related discipline and a minimum of 11 years of related experience; or Master’s degree and a minimum of 9 years; or Doctoral degree and a minimum of 5 years; or equivalent combination of education and experience
Experience in biotech/pharmaceutical industry required
Current understanding of the relevant external scientific, legal and regulatory environment
Strong knowledge of biopharmaceutical industry regulations, standards and best practices
Self-starter, quick learner, strong collaborator and team player
Ability to work independently with minimal supervision
Excellent analytical, strategic thinking, problem-solving, time management, change management and organizational skills
Ability to work in a fast-paced environment and adapt to changing business plans and priorities
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