Senior Manager/Associate Director, Clinical Operations

Outpacebio; Seattle (WA); On-site; USD 130,000 - 160,000; Full time

Benefits offered by this job

Medical insurance

401(k) plan with employer match

Flexible PTO

Job summary

Outpacebio is seeking a Senior Manager/Associate Director of Clinical Operations to oversee operational aspects of cell-therapy clinical trials. The ideal candidate will have at least 8 years of experience in clinical research, including 5 years in trial management, and robust oncology experience, particularly in CAR-T therapies.

This role requires excellent analytical and organizational skills and the ability to thrive in a fast-paced environment. The position offers full-time benefits, including health, dental, and flexible PTO.

Qualifications

• Minimum of 8 years of experience in the clinical research industry, including at least 5 years of trial management experience.
• Strong analytical and critical thinking skills to evaluate complex issues.
• Good understanding of FDA and ICH GCP guidelines.

Responsibilities

• Oversee all operational aspects of assigned clinical trials.
• Develop strong vendor and site relationships.
• Lead assigned meetings and provide updates on trial status.
• Identify and mitigate risks during trials.
• Ensure compliance with relevant standards.

Skills

Trial management experience

Oncology experience

Analytical skills

Organizational skills

Communication skills

Education

Bachelor’s Degree or U.S. equivalent

Job description

Senior Manager/Associate Director, Clinical Operations

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.), and oversee CROs, vendors and consultants.

• Trial‑level oversight and leadership of assigned cell‑therapy clinical trial(s) in a cross‑functional environment.
• Obtains and maintains an in‑depth understanding of the trial protocol and related procedures to share best practices, make recommendations for continuous improvement and provide training as appropriate.
• Develops strong vendor and site relationships and ensures continuity of relationships through all phases of the trial.
• Develops recruitment and slot management strategies.
• Leads assigned meetings (cross‑functional internal, vendor, and/or investigator) and provides regular updates on trial status (agenda development, minutes curation and filing).
• Idents risks, mitigates and manages them, including timely issue review, escalation and management to support trend analysis and risk prevention.
• Manages CTMS and eTMF to ensure compliance/inspection readiness, support trend analyses and support timelines.
• Reviews EDC design specifications, participates in UAT, and contributes to the development and review of associated plans and completion guidelines.
• Reviews clinical data to ensure timely entry and readiness for data review meetings and supports the data cleaning/query process.
• Reviews clinical monitoring reports to ensure timely completion and identify issues.
• Completes and maintains internal clinical trial metrics, dashboards and other internal updates.
• Ensures trials are conducted in accordance with Outpace Bio and ICH/GCP standards.
• Coordinates and manages various tasks in collaboration with other roles to achieve site readiness, such as trial materials and approval for drug shipping/receipt according to procedure.
• Other responsibilities as assigned.

Qualifications

• Bachelor’s Degree or U.S. equivalent required.
• Minimum of 8 years of experience in the clinical research industry, including at least 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 to evaluate complex issues from multiple perspectives and actively develop strategies to support acceleration of trial timelines and enable a well‑run trial.
• Excellent organizational and time‑management skills, strong attention to detail.
• 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.

The salary range is based on Outpace Bio's reasonable estimate of base salary for this role at the time of posting. Actual base salary will be based on a variety of factors including skills, experience, and other related factors permitted by law.

Outpace Bio Total Rewards

Full‑time employees and their eligible dependents may enroll in Outpace's medical, dental, vision, life insurance, disability, flexible spending account, health savings account, commuter benefits, legal benefits, and 401(k) plan (including an employer match). In addition, employees may receive stock option grants and a performance bonus. Outpace employees enjoy flexible PTO, paid sick leave complying with local requirements, fifteen paid holidays plus a winter shutdown, and a generous paid parental leave policy to all regular full‑time employees.

Outpace Bio is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information, gender identity and expression, veteran status, or other prohibited grounds specified in applicable federal, state and local laws.