Associate Clinical Operations Compliance Director (Biotechnology Oncology)

Exelixis Inc.; United States; Remote; USD 190,000 - 241,000; Full time

Benefits offered by this job

401k plan with generous company/conhem

group medical, dental and vision

life and disability insurance

flexible spending accounts

discretionary annual bonus program

stock purchase program

long-term incentives

vacation days and holidays

sick days

Job summary

Exelixis Inc. is seeking an Associate Clinical Operations Compliance Director to enhance oncology clinical research by adhering to ICH GCP and international regulations. You will focus on risk/issue management, vendor oversight, site monitoring, and data integrity while partnering with QA and Clinical Development teams.

This role supports inspection readiness and cross-study consistency across processes. The position emphasizes training, analytics, BIMO/inspection readiness, and RBQM oversight.

Qualifications

• Bachelor’s degree with 11+ years of related experience; Master’s with 9+; Doctoral with 5+; or equivalent combo.
• Experience in biotech/pharmaceutical industry and regulatory environment.
• Strong knowledge of biopharmaceutical industry regulations, standards and best practices.

Responsibilities

• Support risk and issue management for Clinical Operations ensuring compliant study delivery.
• Contribute to risk management strategy and annual functional risk plan for inspection readiness.
• Support CAPA owners with assignments, follow-up and closure.
• Assist updates on CAPA completion data and remediation.
• Act as liaison with QA and other R&D functions; ensure cross-functional collaboration.
• Manage areas: Training & Analytics, Inspection Readiness, RBQM/RBM & Monitoring Oversight.

Skills

GCP compliance knowledge

Risk & issue management

CAPA management

Inspection readiness

Cross-functional collaboration

Vendor oversight

Data monitoring oversight

Executive communication

Excel/Office proficiency

Education

Bachelor’s degree in related discipline

Master’s degree in related discipline

Doctoral degree in related discipline

Equivalent combination of education and experience

Tools

Microsoft Excel

Word

PowerPoint

Job description

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 elevate 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;
• Master’s degree in related discipline and a minimum of 9 years of related experience;
• Doctoral degree in related discipline and a minimum of 5 years of related experience;
• 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

• 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

Location: Remote

Range for this position: $190,000 - $241,000

The base pay offered will take into account job-related knowledge, skills, experience and internal equity, among other factors.

Benefits

• 401k plan with generous company contributions
• group medical, dental and vision coverage
• life and disability insurance
• flexible spending accounts
• discretionary annual bonus program, or if field sales staff, a sales-based incentive plan
• employees the opportunity to purchase company stock
• receive long-term incentives
• 15 accrued vacation days in their first year
• 17 paid holidays including a company-wide winter shutdown in December
• up to 10 sick days throughout the calendar year

Equal Opportunity Employer

Exelixis is an Equal Opportunity Employer. We are committed to fostering an inclusive environment where everyone can thrive. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy (including lactation, childbirth, or related medical conditions), sexual orientation, gender identity, age (40 and over), national origin or ancestry, citizenship or immigration status, physical or mental disability, genetic information (including testing and characteristics), veteran status, uniformed servicemember status, or any other characteristic protected by applicable federal, state, or local law. We are also committed to providing reasonable accommodations to qualified individuals with disabilities, unless undue hardship and/or a direct threat to the health and/or safety of the individual or others would result.

If you have a disability and need an accommodation in relation to the recruiting process, please email us at: [e-mail] .

Exelixis is an E-Verify employer.

Working Conditions

Our office is a modern 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.

Disclaimer

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.