Associate Director/Director, Translational Sciences
Job Description
Position Overview
Outpace Bio is pioneering the future of cell therapy for solid tumors through AI-powered protein design. We are seeking an experienced Associate Director/Director of Translational Sciences to lead the development and execution of translational strategies for cellular therapies in solid tumor programs. In this role, you will design and implement biomarker strategies to support patient selection, pharmacokinetics, pharmacodynamics, mechanism of action, resistance and toxicity assessments, and contribute to regulatory submissions. The position reports to the Head of Translational Sciences and can be based in Seattle, WA or remote.
Compensation: The salary range is based on Outpace Bio's reasonable estimate of base salary for this role, with actual compensation determined by skills, experience, and other factors.
Key Responsibilities
- Provide strategic, technical, and scientific leadership to advance fit-for-purpose translational strategies for innovative cell therapy programs.
- Design and deliver translational strategies covering patient selection/stratification, pharmacokinetics, pharmacodynamics, mechanism of action, resistance and toxicity, prognostic and predictive biomarker assessments, and support asset differentiation.
- Manage and communicate key biomarker program information, risks, milestones, and data interpretation to asset teams and stakeholders.
- Prepare and review biomarker sections for candidate nomination dossiers, IND packages, Clinical Development Plans, clinical protocols, ICFs, and regulatory documents.
- Engage with cross-functional teams and external collaborators, including scientific KOLs, to support translational goals and operationalize outsourced assay development/validation.
- Oversee vendor management including agreements, work plans, budgets, assay transfer, and validation to ensure high-quality data output for decision-making.
- Contribute to continuous improvement initiatives within the Translational Sciences team to enhance quality, cost-effectiveness, and scalability.
Required Qualifications
- PhD (or equivalent) in Oncology, Immunology, Cell Biology, or a related field.
- 6-8+ years of experience in oncology drug development (industry experience preferred), with recent focus in cell therapy or immune-oncology.
- 6+ years of experience in translational/biomarkers/correlative research, with a track record of independently leading translational biomarker strategies.
- Strong expertise in developing and validating biomarker assays across various platforms (immune profiling, flow cytometry, tumor tissue imaging, transcriptomics, etc.).
- Experience with clinical laboratory regulatory and compliance requirements (GLP, GCP, GCLP, CLIA, CAP).
- Proven experience in authoring translational sections of regulatory documents including IND packages, Clinical Development Plans, and clinical protocols.
- Excellent communication, influencing, and interpersonal skills with the ability to balance multiple priorities in a dynamic environment.
Benefits & Perks
- Total Rewards: Comprehensive medical, dental, vision, life insurance, and disability coverage.
- Flexible spending accounts, health savings accounts, and commuter benefits.
- 401k plan with employer match, stock option grants, and performance bonuses.
- Generous paid time off (flexible PTO), paid sick leave, fifteen paid holidays, and a winter shutdown.
- Inclusive paid parental leave policy for full-time employees.