SUMMARY/JOB PURPOSE
The Clinical Operations Compliance Director is responsible for ensuring that oncology clinical research activities are conducted in accordance with ICH GCP, applicable international and local regulations, industry standards, and Exelixis policies and procedures. This role provides strategic and operational leadership for compliance related activities within Clinical Operations, with a focus on risk management, issue management, CAPA oversight, vendor oversight, site and data monitoring practices and inspection readiness.
This role serves as a key partner to Quality Assurance and cross-functional stakeholders across Clinical Development, Data Management, Biometrics, Regulatory Affairs and other R&D functions. The Director drives consistency in clinical trial execution, promotes proactive risk identification and mitigation, supports audit and inspection readiness, and enables continuous process improvement through analysis of compliance metrics, trends and operational data.
The Director influences organizational compliance strategy, contributes to the development and implementation of standardized processes and tools, and provides leadership in resolving complex compliance and operational challenges across the clinical development portfolio.
ESSENTIAL DUTIES/RESPONSIBILITIES
- Lead the execution and continuous improvement of the Clinical Operations risk and issue management program to support compliant and efficient study conduct.
- Partner with Clinical Operations leadership and cross-functional stakeholders to identify, assess, mitigate and escalate risks impacting clinical trial quality, compliance and execution.
- Contribute to the development and implementation of functional risk management strategies and annual risk management plans to support inspection readiness.
- Review, analyze and communicate compliance trends, quality metrics, key risk indicators, and inspection readiness measures to functional leadership.
- Support the management and oversight of CAPAs, ensuring appropriate ownership, tracking, timely completion and effectiveness evaluation.
- Provide regular updates and recommendations to Clinical Operations leadership regarding CAPA status, compliance risks, trends and emerging issues.
- Collaborate closely with Quality Assurance to support internal audits, regulatory inspections, inspection readiness activities and follow-up actions.
- Drive cross-study consistency in clinical trial execution through the development, implementation and adoption of standardized processes, templates and best practices.
- Facilitate the identification and resolution of significant operational and quality issues and ensure appropriate escalation through governance structures.
- Support oversight of clinical vendors and CRO partnerships to ensure adherence to quality and compliance expectations.
- Utilize operational and compliance data to identify opportunities for process improvement, risk reduction and enhanced quality management.
- Serve as subject matter expert for Clinical Operations compliance-related processes and provide guidance, training and consultation to functional stakeholders.
- Partner with leadership across R&D to foster a culture of quality, inspection readiness and proactive compliance management.
- 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
EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIES
Education
- Bachelor's degree in related discipline and a minimum of 13 years of related experience; or,
- Master's degree in related discipline and a minimum of 11 years of related experience; or,
- Doctoral degree in related discipline and a minimum of 8 years of related experience; or,
- Equivalent combination of education and experience.
Experience
- Experience in biotech/pharmaceutical industry required.
- Experience in biotech/pharmaceutical industry: CROs, R&D outsourcing, purchasing or procurement roles required.
- Evidence of leadership and management skills in a relevant industry role involving strong engagement with external suppliers.
- Prior experience leading a team.
Knowledge, Skills and Abilities
Required:
- Leadership and networking skills.
- Communication and engagement skills.
- Current understanding of the relevant external scientific, legal and regulatory environment.
- Partnership and collaboration skills.
- Influencing skills to drive robust oversight processes across a complex supplier landscape.
- In-depth knowledge of biopharmaceutical industry regulations, standards and best practices.
- Poise and confidence to provide verbal and written communications and formal presentations to Exelixis' and external vendors' executives, senior management, functional management and individual contributors.
- 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.
#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 $179,500 - $256,000 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: ApplicantAccommodations@exelixis.com.
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.
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.
