Associate Clinical Operations Compliance Director – Biotechnology Oncology

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

📋 Description

• Assist in the management of risks and issues within Clinical Operations.

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

• Help develop the annual risk management plan for the function to ensure readiness for inspections.

• Work collaboratively across functions on risk management initiatives and escalate issues to the relevant governance bodies.

• Support the CAPA owners in Clinical Operations, including assignment, follow-up, and completion of tasks.

• Aid in updating CAPA completion statistics.

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

• Develop a standardized curriculum for GCP and process training.

• Foster ongoing capability development and knowledge sharing.

• Establish and update quality metrics to monitor progress and consistency within Clinical Operations.

• Promote continuous inspection readiness across studies.

• Maintain TMF audit-readiness and conduct mock inspections.

• Follow up on CAPAs and lead responses to BIMO and health authority inspections.

• Supervise monitoring quality and the performance of CROs.

• Manage risk-based monitoring signals and ensure timely escalation of site and data issues.

• Perform additional duties as required.

• Adhere to all policies and standards.

⛳️ Requirements

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

• Required experience in the biotech or pharmaceutical industry.

• Current knowledge of the relevant external scientific, legal, and regulatory landscape.

• Strong understanding of regulations, standards, and best practices in the biopharmaceutical industry.

• Self-motivated, quick to learn, and an effective collaborator and team player.

• Capability to work independently with minimal supervision.

• Excellent analytical, strategic thinking, problem-solving, time management, change management, and organizational skills.

• Ability to thrive in a fast-paced environment and adjust to shifting business plans and priorities.

• Strong interpersonal, verbal, and written communication abilities.

• Keen attention to detail.

• Proficient in identifying and communicating issues and risks.

• Excellent presentation skills.

• Ability to build and maintain strong professional relationships.

• Capability to influence others without direct authority.

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

🏝️ Benefits

• 401k plan with generous contributions from the company.

• Medical, dental, and vision insurance coverage.

• Life and disability insurance plans.

• Flexible spending accounts available.

• Discretionary annual bonus program.

• Opportunity to purchase company stock.

• Long-term incentive programs.

• 15 accrued vacation days in the first year.

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

• Up to 10 sick days each calendar year.

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