Revolutionizing Cell Therapy with Protein Design

Director, Translational Sciences

TranslatorTranslatorFull TimeRemoteTeam 51-200H1B SponsorCompany Site LinkedIn

Location

Washington

Posted

132 days ago

Salary

$158K - $230K / year

Postgraduate Degree6 yrs expEnglishGoogle Cloud Platform

Job Description

• 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.

Job Requirements

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.
Understanding of and experience planning and executing patient selection plans and development of CDx strategies preferred
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

Benefits

Full time employees and their eligible dependents may enroll in Outpace's medical, dental, vision, life insurance, disability, flexible spending account, and 401k plan.
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.