Senior Manager/Associate Director, Clinical Operations

About the role

Outpace Bio is pioneering the future of cell therapy for solid tumors by harnessing unrivaled AI-powered protein design. Our mission is to program immune cells for enhanced function inside patients, overcoming key barriers such as poor tumor access, weak survival, antigen escape, and dose-related toxicity. By creating and integrating modular, plug-and-play technology assets, we are developing cell therapies with unprecedented efficacy, transforming how engineered T cells interact with cancer and the immune system to deliver life-changing outcomes. Our multidisciplinary team of scientists, engineers, coders, and cell therapy developers works at the cutting edge of computational protein design, synthetic biology, and immunology. Together, we are reimagining how cells function to unlock novel therapeutic possibilities.

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 in order to contribute strongly to trial team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
• 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) and provision of regular updates on trial status, e.g., agenda development, minutes curation and filing.
• Risk identification, mitigation, and management, including timely issue review, escalation, and management to support trend analysis and risk prevention.
• CTMS and eTMF management to ensure compliance/inspection readiness, support trend analyses and support timelines.
• Review of EDC design specifications, participation in user acceptance testing, and contribution to development and review of associated plans and completion guidelines.
• Review clinical data to ensure timely entry and readiness for data review meetings and support data cleaning/query process.
• Review clinical monitoring reports to ensure timely completion and identification of issues.
• Ensure trials are conducted in accordance with Outpace Bio and ICH/GCP standards.
• Covers coordination & management of 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.

Requirements

• Bachelor’s Degree or ex-US equivalent required.
• Minimum of 8 years of experience in the clinical research industry, including a 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 to evaluate complex issues from multiple perspectives to actively develop strategies and drive smart decision making 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.

Pay

$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.

Schedule

Remote - candidates based in the following states will be considered to align with company operations: CA, OR, or WA.

Benefits

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 401k plan which includes an employer match. In addition, employees may receive stock option grants to be outlined in their offer of employment and a performance bonus.

Total Rewards

Outpace Bio offers an exciting opportunity to contribute to groundbreaking research that has the potential to transform the lives of people around the world. Outpace Bio Total Rewards includes:

• Flexible PTO
• Paid sick leave which complies with local requirements
• Fifteen paid holidays plus a winter shutdown
• A generous paid parental leave policy to all regular full-time employees

EEO Statement

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 or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

Equal Opportunity Employer

Outpace Bio does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Outpace Bio or its employees is strictly prohibited unless contacted directly by Outpace Bio's internal team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Outpace Bio and will not owe any referral or other fees.