Senior Clinical Trial Manager

Outpacebio ā€¢ USA

Company

Outpacebio

Location

USA

Type

Full Time

Job Description

About Outpace Bio
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.Located in Seattleā€™s vibrant biotech hub overlooking scenic Lake Union, Outpace Bio is led by pioneers in computational protein design and engineered cell therapies. Our culture is built on a foundation of respect and inclusion, which are fundamental to how we collaborate to revolutionize cell therapy through groundbreaking innovation rooted in rigorous science.

Our Commitment to Diversity
At Outpace Bio, we believe that the highest performing teams include people from a wide variety of backgrounds and experiences. We are committed to cultivating an open, diverse, and inclusive culture for all employees. Recognizing that the best candidates do not always match all criteria of the job description, we encourage you to apply if you think you would be a good fit for the role and are inspired by our mission to cure disease by pushing the boundaries of biology.

Our Momentum
In August 2024, Outpace Bio secured an oversubscribed $144 million Series B financing, led by RA Capital Management and supported by a premier syndicate of life science investors. This funding accelerates our pipeline of programmed T cell therapies, including our lead candidate OPB-101, a mesothelin-specific chimeric antigen receptor (CAR) T cell enhanced by Outpaceā€™s proprietary OUTSMARTā„¢, OUTLASTā„¢, OUTSPACERā„¢, and OUTSAFEā„¢ technologies. OPB-101 is advancing toward IND clearance and first dosing in 2025 for patients with advanced platinum-resistant ovarian cancers. The Series B investment also supports the expansion of our pipeline, enabling us to develop additional transformative therapies leveraging our innovative plug-and-play technology platform.

The Senior Clinical Trial Manager (Sr CTM), with support and guidance from Clinical Operations leadership, is responsible for all operational aspects of assigned cell-therapy clinical trial(s) from setup through final report.Ā The Sr CTM ensures 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.


Responsibilities (Position responsibilities may include, but are not limited to):
  • 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.
  • 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, such as trial materials and approval for drug shipping/receipt according to procedure.
  • Other responsibilities as assigned.


    • Qualifications (Required):
  • Bachelorā€™s Degree or ex-US equivalent required.
  • Minimum of 6 years of experience in the clinical research industry, including a minimum of 3 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.
    • 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.

    Working at Outpace 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
    Full time employees and their eligible dependents may enroll in Outpace's medical, dental, vision, life insurance, disability, flexible spending account, and 401k plan. In addition, employees may receive stock option grants to be outlined in their offer of employment. Outpace employees enjoy flexible PTO, paid sick leave which complies with local requirements, and fifteen paid holidays plus a winter shutdown. Outpace also offers 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 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.

    Applicants must be authorized to work in the United States. If you are legally authorized to work in the United States now, or in the future without any form of sponsorship, we encourage you to apply.
    Apply Now

    Date Posted

    12/24/2024

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