[Hiring] Senior Manager/Associate Director, Clinical Operations @Outpace Bio

Role Description

The Senior Manager/Associate Director, Clinical Operations, with support and guidance from Clinical leadership, is responsible for all operational aspects of assigned cell-therapy clinical trial(s) from setup through final report. They ensure assigned trials are executed with quality, compliance, and efficiency, in accordance with regulations, timelines, and budget. The candidate will coordinate the activities of several other clinical team members (e.g., CRAs, CTAs, Logistics, etc.), as well as oversee CROs, vendors, and consultants.

Key Responsibilities

• Trial-level oversight and leadership of assigned cell-therapy clinical trial(s) in a cross-functional environment.
• Obtains and maintains in-depth understanding of the trial protocol and related procedures.
• Develops strong vendor and site relationships and ensures continuity of relationships through all phases of the trial.
• Develops recruitment and slot management strategies.
• Leadership of assigned meetings (cross-functional [internal], vendor, and/or investigator).
• Risk identification, mitigation, and management.
• CTMS and eTMF management to ensure compliance/inspection readiness.
• Review of EDC design specifications and participation in user acceptance testing.
• Review clinical data to ensure timely entry and readiness for data review meetings.
• Review clinical monitoring reports to ensure timely completion and identification of issues.
• Complete and maintain internal clinical trial metrics, dashboards, and other internal updates.
• Ensure trials are conducted in accordance with Outpace Bio and ICH/GCP standards.
• Coordinates & manages various tasks in collaboration with other roles to achieve site readiness.
• Other responsibilities as assigned.

Qualifications

• Bachelor’s Degree or ex-US equivalent required.
• Minimum of 8 years of experience in the clinical research industry.
• Minimum of 5 years of trial management experience.
• Robust oncology experience required including early-stage experience and cell or gene therapy (highly complex such as CAR-T).
• Strong analytical and critical thinking skills.
• Excellent organizational and time management skills.
• Ability to work independently and thrive in a fast-paced evolving environment.
• Good understanding of FDA and ICH GCP guidelines.
• Excellent verbal and written communication skills.

Requirements

• $160,000 - $217,000 a year.
• This position is a Senior Manager or Associate Director level position with a compensation range of $160,000-$189,000 for a Senior Manager level and $180,000-$217,000 for an Associate Director level.
• Actual compensation is dependent upon current market data, experience, and pay parity at Outpace.
• LOCATION: Remote - candidates based in CA, OR, or WA will be considered.

Benefits

• Medical, dental, vision, life insurance, disability, flexible spending account, health savings account, commuter benefits, legal benefits, and 401k plan with employer match.
• Stock option grants and performance bonus.
• Flexible PTO and paid sick leave.
• Fifteen paid holidays plus a winter shutdown.
• Generous paid parental leave policy for all regular full-time employees.