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Outpace Bio · 2 months ago

Associate Director/Director, Translational Sciences

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$158K/yr - $230K/yr

6+ years exp

Outpace Bio is pioneering the future of cell therapy for solid tumors through AI-powered protein design. The Associate Director/Director of Translational Sciences will lead the development and execution of translational strategies for cellular therapies, focusing on delivering actionable data to support clinical development and managing outsourced assay development.

BiotechnologyHealth CareLife SciencePharmaceutical

No H1B

Responsibilities

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 development

Productively 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

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

Qualification

Translational strategy designBiomarker assay developmentOncology drug developmentPatient selection strategyVendor managementCommunicationCollaborative mindsetStrategic thinking

Required

PhD 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 research

Proven experience of independent leadership of translational biomarker strategy for oncology programs, including study design, operational startup and execution, data generation and analysis

Strong understanding of translational approaches as applied to clinical trial design and regulatory processes, proof-of-concept studies, and the implementation of biomarkers and diagnostics

Excellent 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

Working 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 solutions

Demonstrated 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