Senior Manager/Associate Director, Clinical Operations

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

📋 Description

• Accountable for all operational components of designated cell-therapy clinical trial(s) from initiation to the final report.

• Ensure that the designated trials are conducted with high standards of quality, compliance, and efficiency, adhering to regulations, timelines, and budget constraints.

• Facilitate the coordination of various clinical team members' activities (e.g., CRAs, CTAs, Logistics, etc.).

• Supervise CROs, vendors, and consultants.

⛳️ Requirements

• A Bachelor’s Degree or its equivalent from outside the US is required.

• At least 8 years of experience in the clinical research field, with a minimum of 5 years in trial management.

• Significant oncology experience is essential, including early-stage involvement and experience with highly complex cell or gene therapies such as CAR-T.

• Strong analytical and critical thinking abilities to assess complex issues from various angles to actively formulate strategies and make well-informed decisions that support the acceleration of trial timelines and ensure a smoothly run trial.

• Exceptional organizational and time management capabilities, with a keen attention to detail.

• Capability to work autonomously and excel in a dynamic, fast-paced environment.

• Solid understanding of FDA and ICH GCP guidelines.

• Outstanding verbal and written communication skills.

🏝️ Benefits

• Medical insurance

• Dental insurance

• Vision insurance

• Life insurance

• Disability insurance

• Flexible spending account

• Health savings account

• Commuter benefits

• Legal benefits

• 401k plan with employer match

• Stock option grants

• Performance bonus

• Flexible PTO

• Paid sick leave

• Fifteen paid holidays

• Winter shutdown

• Generous paid parental leave policy