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 final reporting.

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

• Coordinate the efforts of various members of the clinical team (e.g., CRAs, CTAs, Logistics, etc.).

• Supervise CROs, vendors, and consultants.

⛳️ Requirements

• A Bachelor’s Degree or 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.

• Strong oncology background is essential, including experience in early-stage trials and complex cell or gene therapies (such as CAR-T).

• Exceptional analytical and critical thinking abilities to assess intricate issues from various angles, actively formulating strategies and making informed decisions to support the acceleration of trial timelines and ensure efficient trial management.

• Outstanding organizational and time management skills, with a keen eye for detail.

• Capable of working autonomously and excelling in a dynamic, fast-paced environment.

• Solid understanding of FDA and ICH GCP guidelines.

• Excellent 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