Associate Clinical Operations Compliance Director (Biotechnology Oncology)

SUMMARY/JOB PURPOSE

The Associate Clinical Operations Compliance Director will support oncology clinical research activities in accordance with ICH GCP, relevant international and local regulations, requirements and guidelines, as well as Exelixis written standards. Supports the focus on risk management, issue management, vendor oversight and site and data monitoring. The Associate Clinical Operations Compliance Director is a key partner with our Quality Assurance team and other functional groups (including Clinical Development, Data Management, etc.) and will assist in supporting inspection readiness activities, driving cross-study consistency in study execution and compliance with governing functional procedures and processes, and escalation of identified operational issues within development and of identified quality issues to QA.

ESSENTIAL DUTIES/RESPONSIBILITIES

• Support the risk and issue management process for Clinical Operations focusing on compliant delivery of study execution.
• Contribute to strategy and methodology for functional risk/issue management, assist in creating annual functional risk management plan to ensure inspection readiness; collaborate cross-functionally on risk management activities, and escalate to appropriate governance and adapt accordingly.
• Provide support to Clinical Operations (and other functions being supported by embedded compliance role) CAPA owners, including owner assignment, follow-up and completion.
• Assist with updates on CAPA completion data (late, near due, due later).
• Work closely with and act as liaison for Quality Assurance team and other functional teams across R&D and beyond.
• Will be responsible for one or more areas:

• Training, Capability & Analytics - Build a standardized GCP and process training curriculum, drive ongoing capability and knowledge sharing and build and renew quality metrics to track progress and consistency across Clinical Operations.
• BIMO & Inspection Readiness - Drive continuous inspection readiness across studies, keep TMF audit-ready, run mock inspections and CAPA follow-up and lead BIMO and health authority inspection response.
• RBQM/RBM & Monitoring Oversight - Oversight of monitoring quality and CRO performance, risk-based monitoring signals and timely escalation of site and data issues.

• Performs other duties as assigned
• Complies with all policies and standards

SUPERVISORY RESPONSIBILITIES

• None

EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIES

Education

• Bachelor’s degree in related discipline and a minimum of 11 years of related experience; or,
• Master’s degree in related discipline and a minimum of 9 years of related experience; or,
• Doctoral degree in related discipline and a minimum of 5 years of related experience; or,
• Equivalent combination of education and experience.

Experience

• Experience in biotech/pharmaceutical industry required.
• Current understanding of the relevant external scientific, legal and regulatory environment.

Knowledge, Skills and Abilities

Required:

• Strong knowledge of biopharmaceutical industry regulations, standards and best practices.
• Must be a self-starter, quick learner, strong collaborator and team player with ability to work independently with minimal supervision.
• Must have excellent analytical, strategic thinking, problem-solving, time management, change management and organizational skills with demonstrated 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.

Environmental Requirements:

• Our office is a modern, open-plan space that fosters collaboration and creativity.
• Teams work closely together, sharing ideas and solutions in a supportive atmosphere.
• We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

#LI-JD1

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $168,500 - $238,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. …