Associate Clinical Operations Compliance Director (Biotechnology Oncology)

Exelixis; United States; Vor Ort; USD 169.000 - 239.000; Vollzeit

Benefits dieser Stelle

401k plan

Medical insurance

Dental & Vision

Life & Disability insurance

Flexible spending accounts

Annual bonus program

Stock purchase plan

Long-term incentives

Paid vacation days

Paid holidays

Sick days

Zusammenfassung

Exelixis is seeking an Associate Clinical Operations Compliance Director to support oncology trials in line with ICH GCP and applicable regulations. You will partner with QA and development teams to drive risk management, issue tracking, CAPA oversight and inspection readiness across studies.

Responsibilities include supervising CAPA owners, coordinating with CROs, monitoring RBQM, and ensuring TMF readiness while contributing to strategy and governance in a fast-paced biotech environment.

Qualifikationen

• Bachelor’s degree in related discipline with 11+ years of related experience, or Master’s degree with 9+ years, or Doctoral degree with 5+ years.
• Experience in biotech/pharmaceutical industry required.
• Strong regulatory knowledge and ability to work independently.

Aufgaben

• Support risk and issue management for compliant study delivery.
• Contribute to functional risk management plans and inspection readiness.
• Assist CAPA owners and monitor CAPA completion.
• Collaborate with QA and cross-functional teams across R&D.
• Drive BIMO, inspection readiness and RBQM oversight.

Kenntnisse

Risk management

Issue management

GCP compliance

Regulatory knowledge

Cross-functional collaboration

Data monitoring

Inspection readiness

CAPA process

Vendor oversight

Communication skills

Ausbildung

Bachelor’s degree in life sciences

Master’s degree preferred

Doctoral degree optional

Tools

Excel

Word

PowerPoint

Outlook

Jobbeschreibung

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

• 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

• 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

Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $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: [e-mail].

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.