Clinical Operations Compliance Director – Biotechnology Oncology

This is a fully remote position, open to applicants in United States.

📋 Description

• Ensure that oncology clinical research initiatives align with ICH GCP, relevant international and local regulations, industry benchmarks, and the policies and procedures of Exelixis.

• Deliver strategic and operational leadership for compliance activities within Clinical Operations.

• Lead and enhance the Clinical Operations risk and issue management program continuously.

• Identify, evaluate, mitigate, and escalate risks that impact the quality, compliance, and execution of clinical trials.

• Formulate and execute functional risk management strategies and annual risk management plans.

• Analyze, review, and communicate compliance trends, quality metrics, key risk indicators, and measures for inspection readiness.

• Supervise CAPAs, including ownership, tracking, timely resolution, and effectiveness assessment.

• Provide updates and recommendations to Clinical Operations leadership regarding CAPAs, compliance risks, trends, and emerging challenges.

• Collaborate with Quality Assurance on internal audits, regulatory inspections, inspection readiness, and follow-up actions.

• Design, implement, and promote standardized processes, templates, and best practices across various studies.

• Facilitate the resolution and escalation of significant operational and quality challenges through governance frameworks.

• Oversee clinical vendors and CRO partnerships to ensure adherence to quality and compliance standards.

• Leverage operational and compliance data to identify opportunities for process improvement and risk reduction.

• Act as a subject matter expert, providing guidance, training, and consultation on Clinical Operations compliance processes.

• Cultivate a culture of quality, inspection readiness, and proactive compliance management within R&D.

• Develop standardized GCP training curricula, capability programs, and quality metrics.

• Drive inspection readiness, TMF audit preparedness, mock inspections, CAPA follow-up, and responses to BIMO/health authority inspections.

• Monitor quality, CRO performance, risk-based monitoring signals, and escalate site and data issues as needed.

• Perform additional duties as assigned and adhere to established policies and standards.

⛳️ Requirements

• Bachelor's degree in a related field with a minimum of 13 years of relevant experience; or a Master's degree in a related field with a minimum of 11 years of relevant experience; or a Doctoral degree in a related field with a minimum of 8 years of relevant experience; or an equivalent combination of education and experience.

• Required experience in the biotech/pharmaceutical industry.

• Required experience in the biotech/pharmaceutical sector involving CROs, R&D outsourcing, purchasing, or procurement roles.

• Demonstrated leadership and management abilities in a relevant industry role with strong engagement with external suppliers.

• Previous experience leading a team is necessary.

• Current knowledge of the pertinent external scientific, legal, and regulatory landscape.

• Comprehensive understanding of biopharmaceutical industry regulations, standards, and best practices.

• Strong skills in leadership, networking, communication, engagement, partnership, collaboration, and influence.

• Ability to work independently with minimal supervision.

• Exceptional analytical, strategic thinking, problem-solving, time management, change management, and organizational skills.

• Strong interpersonal, verbal, and written communication abilities.

• Keen attention to detail.

• Capability to identify and communicate potential issues and risks.

• Excellent presentation skills.

• Ability to forge and maintain strong relationships.

• Ability to influence others without direct authority.

• Proficient computer skills, including advanced knowledge of Microsoft Excel, Word, PowerPoint, and Outlook.

🏝️ Benefits

• 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 recruitment process.