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

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

📋 Description

• Ensure that clinical research activities adhere to ICH GCP, applicable international and local regulations, guidelines, and Exelixis standards.

• Lead the management of risks and issues within Clinical Operations, ensuring compliant execution of studies.

• Provide trend analysis and relevant reporting to Process Owners, Clinical Operations, and Leadership Teams.

• Transform trends into process enhancements and risk-informed decisions.

• Establish a strategy and methodology for functional risk and issue management.

• Develop an annual functional risk management plan to ensure inspection readiness.

• Review outcomes related to risk management and monitoring activities.

• Collaborate across functions on risk management efforts and escalate issues to the appropriate governance bodies.

• Assist Clinical Operations CAPA owners with task assignment, follow-up, and resolution.

• Provide updates on CAPA completion to development leadership.

• Liaise with Quality Assurance and various functional teams throughout R&D and beyond.

• Promote a unified approach to study conduct, compliance, risk and issue management, as well as protocol deviations.

• Support inspection readiness and ensure consistency in execution and compliance across studies.

• Streamline and standardize processes and templates across functions.

• Assist in the development and utilization of Clinical Operations systems.

• Leverage internal and external data to pinpoint change drivers and suggest process improvements.

• Lead, design, and implement changes across a diverse network of stakeholders and subject matter experts.

• Integrate a risk and issue management framework into operations.

• May supervise direct reports and/or consultants.

⛳️ Requirements

• Bachelor’s degree in a related field with at least 15 years of relevant experience; or a Master’s degree with a minimum of 13 years; or a Doctoral degree with at least 12 years; or an equivalent combination of education and experience.

• Minimum of 15 years of relevant experience, with a combination of education, training, and experience.

• Experience within the biotech/pharmaceutical industry is required.

• Experience working with CROs, R&D outsourcing, purchasing, or procurement roles is essential.

• Proven senior-level leadership and management experience with external suppliers.

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

• Previous experience in leading a team.

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

• Strong leadership, networking, communication, engagement, partnership, collaboration, and influencing abilities.

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

• Exceptional interpersonal, verbal, and written communication skills.

• Keen attention to detail.

• Ability to identify and convey issues and risks effectively.

• Proficient presentation skills.

• Capability to build and sustain strong relationships.

• Ability to influence without having direct authority.

• Excellent computer proficiency, particularly in advanced features of Microsoft Excel, Word, PowerPoint, and Outlook.

• Capacity to work independently with minimal supervision and adapt to evolving business priorities.

• Willingness to travel occasionally, less than 10% of the time.

🏝️ Benefits

• 401k plan with generous company contributions.

• Comprehensive 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 available throughout the calendar year.

• Necessary equipment provided, including dual monitors and ergonomic chairs.