Associate Clinical Operations Compliance Director – Biotechnology Oncology

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in managing the risk and issue processes within Clinical Operations.

• Contribute to the strategy and methodology for functional risk and issue management.

• Aid in developing the annual functional risk management plan to ensure inspection readiness.

• Work collaboratively across functions on risk management initiatives and elevate issues to governance.

• Support CAPA owners in Clinical Operations with task assignment, follow-up, and finalization.

• Help in updating CAPA completion data.

• Serve as a liaison between Quality Assurance and other teams within R&D.

• Develop standardized training curriculum for GCP and processes.

• Promote capability enhancement and knowledge sharing.

• Establish and refresh quality metrics for Clinical Operations.

• Ensure continuous inspection readiness across various studies.

• Maintain the TMF in an audit-ready state and conduct mock inspections.

• Monitor the progress of CAPAs and lead responses for BIMO and health authority inspections.

• Supervise the quality of monitoring and the performance of CROs.

• Manage risk-based monitoring signals and escalate site and data-related issues.

• Execute other assigned duties as necessary.

• Adhere to all policies and standards.

⛳️ Requirements

• Bachelor’s degree in a relevant field with at least 11 years of related experience; or a Master’s degree with a minimum of 9 years; or a Doctoral degree with at least 5 years; or a suitable combination of education and experience.

• Required experience in the biotech or pharmaceutical industry.

• Up-to-date knowledge of the external scientific, legal, and regulatory landscape.

• Comprehensive understanding of industry regulations, standards, and best practices in biopharmaceuticals.

• Capability to work independently with little supervision.

• Strong analytical skills, strategic thinking, and problem-solving abilities, along with effective time and change management skills.

• Excellent interpersonal, verbal, and written communication skills.

• Great attention to detail.

• Proficient in identifying and articulating issues and risks.

• Exceptional presentation abilities.

• Skillful in building and maintaining robust relationships.

• Capacity to influence others without direct authority.

• Proficient computer skills, with advanced knowledge of Microsoft Excel, Word, PowerPoint, and Outlook.

🏝️ Benefits

• 401k plan with generous contributions from the company.

• Group medical, dental, and vision insurance coverage.

• Life and disability insurance provided.

• Flexible spending accounts available.

• Discretionary annual bonus program.

• Opportunity to acquire company stock.

• Long-term incentives offered.

• 15 accrued vacation days in the first year.

• 17 paid holidays, including a company-wide winter shutdown in December.

• Up to 10 sick days throughout the year.

• Provision of necessary equipment, such as dual monitors and ergonomic chairs.

• Disability accommodations available during the recruitment process.