New · posted Nov 1
Exelixis · Biotechnology
Associate Clinical Operations Compliance Director (Biotechnology Oncology)
- Remote, US
- Remote
- Full-time
- Director
The role
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
What you need
Two ways to qualify
Bachelor’s
+ 11+ years of experience
Bachelor’s degree in related discipline and a minimum of 11 years of related experience; or,
- or
Master’s
+ 9+ years of experience
Master’s degree in related discipline and a minimum of 9 years of related experience; or,
EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIES Education
- Doctoral degree in related discipline and a minimum of 5 years of related experience; or,
- Equivalent combination of education and experience.
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.
Experience
- Experience in biotech/pharmaceutical industry required.
- Current understanding of the relevant external scientific, legal and regulatory environment.
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
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. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
If you have a disability and need an accommodation in relation to the recruiting process, please email us at: [email protected].
What you'll do
SUPERVISORY RESPONSIBILITIES
- None
Pay and benefits
$168,500 – $238,500 a year
Employer provided401k plan with company contributions
Medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus
Employee stock purchase and long-term incentives
Equal opportunity, accessibility and legal noticesExelixis's statements, word for word
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.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 1% below the US median for Clinical Regulatory Compliance roles at this level.
This roleEmployer provided
Director roles in the US6 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $168,500 | — | $238,500 |
| All US (middle half) | $204,000 | $205,750 | $215,375 |
This role: Exelixis's own published range. Comparisons: the base pay employers published on open Clinical Regulatory Compliance roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Skills DNA
What this role leans on
How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- GMP and compliance5
- Lab testing and methods3
- Investigations and CAPA3
- Quality systems and risk3
- Data and digital systems2
- Clinical trial conduct2
- Documentation and SOPs1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Exelixis on Regulatory Jobs
- 20
- Open roles
- 20
- Distinct roles
- 2
- Locations
By discipline
- Clinical12 60%
- Quality5 25%
- Regulatory3 15%
By level
- Director15 75%
- Manager2 10%
- VP & Executive1 5%
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Associate Clinical Operations Compliance Director (Biotechnology Oncology) at Exelixis
Open until filled. $169K–$239K a year, employer provided.