Job DescriptionOutpace Bio is seeking a highly talented and experienced Associate Director/Director of Translational Sciences to lead the development and execution of translational strategy for assigned cellular therapies in solid tumor programs. The successful candidate will design and implement fit-for-purpose translational/biomarker strategies for clinical programs, focusing on delivering informative and actionable translational data to support clinical development, including patient selection and stratification, pharmacokinetic, pharmacodynamic, mechanism of action, resistance and toxicity, prognostic and predictive biomarkers. This critical role will manage mostly outsourced assay development/validation, support operationalization of the trial with Central and Specialty Labs, and deliver data and interpretation to the asset team and other stakeholders and contribute to asset team strategy and regulatory submissions. The ideal candidate will have expertise in translational strategy design and execution for cell therapies in oncology, with a proven track record of initiating and delivering on translational plans in phase 1 and later stages clinical trials, and experience with patient selection and CDx strategy. This individual will work in a fast-paced, highly dynamic and collaborative environment, in close collaboration with diverse cross-functional teams. The position reports to the Head of Translational Sciences, and may be located in Seattle, WA or remote.Key ResponsibilitiesTranslational, Strategic and Cross-Functional Leadership:Provide strategic, technical and scientific functional leadership and build productive relationships in matrix teams to advance fit-for-purpose translational strategies in support of Outpace’s innovative cell therapy programs.Design and deliver translational strategies including patient selection/stratification, pharmacokinetic, pharmacodynamic, mechanism of action, resistance and toxicity, prognostic and predictive biomarkers, and support indication expansion, and asset differentiation to support programs in all phases of development.Effectively manage and communicate key biomarker program information, risks, milestones, data and interpretation to asset teams and other stakeholders.Responsible for the preparation and review of biomarker sections of candidate nomination, IND package, Clinical Development Plan, clinical protocols, ICFs and regulatory documents.Act as Translational Sciences representative in relevant asset team and/or lead/contribute to translational subteams in collaboration with translational operations, clinical development, clinical operations, research, CMC, regulatory, quality, program management and business developmentProductively engages with external collaborators and scientific KOLs to support translational goals.Contribute to the growth and excellence of the Translational Sciences team, execute continuous improvement initiatives to enhance quality, cost effectiveness, scalability, and long-term implementation of translational initiatives.Outsourced Translational Vendor Management:Responsible for the engagement and management of outsourced Central and Specialty labs to generate high quality data, according to plan and established timelines.Design and implement fit-for-purpose outsourced qualification/validation for clinical biomarker assays to ensure high scientific quality of target expression, patient selection, PK, target engagement / pharmacodynamics, ATA, prognostic, predictive and safety biomarker data to support program decision-making.QualificationsPhD or equivalent in Oncology, Immunology, Cell Biology or relevant related field preferred with: 6-8+ years of experience in oncology drug development in industry, recent experience in cell therapy or immune-oncology preferred, and 6+ years of experience in translational/biomarkers/correlative researchProven experience of independent leadership of translational biomarker strategy for oncology programs, including study design, operational startup and execution, data generation and analysisStrong understanding of translational approaches as applied to clinical trial design and regulatory processes, proof-of-concept studies, and the implementation of biomarkers and diagnosticsExcellent scientific acumen and strong hands-on experience developing and validating biomarker assays and analyzing data including immune profiling and flow cytometry, tumor tissue imaging and analysis, cell therapy monitoring, transcriptomics and genomics assays, and other cell based and soluble biomarkers.Understanding of and experience planning and executing patient selection plans and development of CDx strategies preferredWorking understanding of clinical laboratory regulatory and compliance requirements (GLP, GCP, GCLP, CLIA, CAP)Experience in authoring of translational sections of candidate nomination, IND package, Clinical Development Plan, clinical protocols, ICFs, regulatory documents submitted to Regulatory Agencies and manuscripts/publications/reviews, scientific presentations of translational data.Significant experience with Vendor Management, oversight responsibilities for agreements, work plans, budget and invoices, assay development, transfer, validation and associated reports, sample analyses and associated reports, data transfers and overall data quality.Excellent communication (written and verbal), influencing, and interpersonal skills. Able to convey complex scientific and business issues to devise, reach agreement on, and implement solutionsDemonstrated ability to think strategically and creatively while managing and prioritizing multiple projects effectively and efficiently. Ability to multitask, drive, manage, execute and independently deliver results for complex multi-functional projects according to established timelines.Passionate for excellent science and innovation, inclusive, open-minded, collaborative, forward-thinking and solution-oriented$158,000 - $230,000 a yearThis position is an Associate Director or Director level position with a compensation range of $158,000-$205,000 for an Associate Director level and $191,000-$230,000 for a Director level. Actual compensation is dependent upon current market data, experience, and pay parity at Outpace.LOCATION: Remote - candidates based in the following states will be considered to align with company operations: CA, OR, or WA.Closing DescriptionThe 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 RewardsFull 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. 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.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.
