Senior Director, Clinical Operations Compliance Management (Biotechnology/Oncology)

Role Summary

The Senior Director, Clinical Operations Compliance Management (COCM) ensures that clinical research activities are conducted in accordance with ICH GCP and applicable regulations and Exelixis standards. The role focuses on risk and issue management, vendor oversight, and site and data monitoring, and collaborates with Quality Assurance and other functions to support inspection readiness and cross-study compliance. The incumbent drives standardized processes, templates, and systems usage within Clinical Operations and uses data to identify improvements and drive change.

Responsibilities

• Leadership of risk and issue management process for Clinical Operations, ensuring compliant study execution.
• Provide trends and reporting to Process Owners and Leadership, translating trends into process improvements and risk-based decisions.
• Define strategy and methodology for functional risk/issue management; create annual risk management plans to ensure inspection readiness; collaborate cross-functionally and escalate as needed.
• Support CAPA owners within Clinical Operations and other supported functions, including assignment, follow-up, and completion.
• Provide development leadership with updates on CAPA completion data (late, near due, due later).
• Collaborate with Quality Assurance and other R&D and functional teams to align on compliance and quality initiatives.

Qualifications

• Education: Bachelor’s degree in a related discipline with a minimum of 15 years of related experience; or Master’s degree with 13 years; or Doctoral degree with 12 years; or an equivalent combination of education and experience.
• Experience: Typically requires a minimum of 15 years of related experience; biotech/pharmaceutical industry experience required; experience with CROs, R&D outsourcing, purchasing or procurement roles preferred; demonstrated leadership of a team at a senior level with external suppliers; knowledge of the external scientific, legal, and regulatory environment; prior team leadership experience.
• Knowledge/Abilities: Leadership and networking; strong communication and engagement; partnership and collaboration; influencing skills for oversight across a supplier landscape; deep knowledge of biopharmaceutical regulations and best practices; robust analytical, strategic thinking, problem-solving, time management, and change management abilities; excellent presentation and relationship-building skills; proficient in Microsoft Office; ability to operate with minimal supervision; ability to travel as needed (less than 10%).

Skills

• Leadership and networking
• Communication and engagement
• Partnership and collaboration
• Influencing across a complex supplier landscape
• Regulatory knowledge and industry best practices
• Executive-level presentation and communication
• Analytical and strategic thinking; problem-solving; time management; change management
• Strong interpersonal, verbal and written communication
• Attention to detail; issue and risk identification and communication
• Excellent computer skills (Excel, Word, PowerPoint, Outlook)

Education

• Bachelor’s degree in related discipline with 15+ years of experience; or Master’s with 13+ years; or Doctoral with 12+ years; or equivalent

Additional Requirements

• Occasional travel to current and/or prospective vendor facilities (< 10%)