Senior Director, Clinical Operations Compliance Management – GCP, Biotechnology, Oncology

Exelixis

Senior Director leading clinical operations compliance for Exelixis, a biotechnology company developing cancer medicines. Driving GCP adherence, risk management, CAPA oversight and inspection readiness.

Posted 8/20/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $246,000 - $349,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in clinical research compliance, risk management, and process improvement within the biotech and pharmaceutical industries. Possesses strong leadership and communication skills to effectively manage cross-functional teams and external suppliers.

Highest-signal resume keywords

Clinical Research ComplianceRisk Management StrategyBiotech/Pharmaceutical Industry ExperienceLeadership and Team ManagementAnalytical and Strategic Thinking

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

ICH GCP ComplianceRisk Management MethodologyProcess ImprovementCAPA ManagementRegulatory Knowledge

Soft Skills

LeadershipCommunicationCollaborationProblem-SolvingAttention to Detail

Tools & Technologies

Microsoft ExcelMicrosoft WordMicrosoft PowerPointMicrosoft Outlook

Industry Keywords

Biopharmaceutical RegulationsCRO ExperienceR&D OutsourcingInspection ReadinessProtocol Deviations

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Ensure clinical research activities comply with ICH GCP, international and local regulations, guidelines and Exelixis standards
Lead risk and issue management for Clinical Operations and support compliant study execution
Provide trends and relevant reporting to Process Owners, Clinical Operations and Leadership Teams
Translate trends into process improvements and risk-based decisions
Define functional risk and issue management strategy and methodology
Create an annual functional risk management plan to support inspection readiness
Review risk management and management-monitoring outcomes
Collaborate cross-functionally on risk management activities and escalate issues to appropriate governance
Support Clinical Operations CAPA owners with assignment, follow-up and completion
Provide development leadership with CAPA completion updates
Liaise with Quality Assurance and functional teams across R&D and beyond
Drive a common approach to study conduct, compliance, risk and issue management, and protocol deviations
Support inspection readiness and cross-study consistency in execution and compliance
Streamline and standardize cross-functional processes and templates
Support development and use of Clinical Operations systems
Use internal and external data to identify change drivers and recommend process improvements
Lead, design and drive changes across a complex network of stakeholders and subject matter experts
Embed a risk and issue management framework
May manage direct reports and/or consultants

Requirements

What you’ll need

Bachelor’s degree in related discipline and a minimum of 15 years of related experience; or Master’s degree and a minimum of 13 years; or Doctoral degree and a minimum of 12 years; or equivalent combination of education and experience
Minimum of 15 years of related experience and/or combination of education/training and experience
Experience in the biotech/pharmaceutical industry required
Experience involving CROs, R&D outsourcing, purchasing or procurement roles required
Senior-level leadership and management experience involving external suppliers
Current understanding of the relevant external scientific, legal and regulatory environment
Prior experience leading a team
In-depth knowledge of biopharmaceutical industry regulations, standards and best practices
Leadership, networking, communication, engagement, partnership, collaboration and influencing skills
Strong 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
Ability to work independently with minimal supervision and adapt to changing business plans and priorities
Willingness to travel occasionally, less than 10%

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