Director, Clinical Biomarker And Bioanalytical Assay

Jounce Therapeutics Cambridge , MA 02138

Posted Yesterday

Role / Responsibilities

We are looking for a highly experienced clinical biomarker professional to pioneer and head up the clinical biomarker/bioanalysis function within Jounce. This person will be a key contributor to the clinical biomarker plan development, and will be responsible for plan implementation including identification of appropriate vendors/platforms, establishment of assays, and oversight of data generation. They will ensure appropriate data analysis and interpretation to support decision-making and reverse translations for Jounce clinical-stage programs. The successful candidate will be responsible for overseeing the scientist(s) responsible for clinical bioanalysis and immunogenicity assays and supporting the development and implementation of fit-for-purpose or GLP-validated non-clinical assays during the IND-enabling stage. The Assay Head will also contribute to the development of companion diagnostic assays, participate in partner selection, and oversee technical performance to ensure that partnered assays are sufficiently validated to meet the necessary regulatory standards and are performed in accordance with those standards. Finally, the individual will serve as a resource for discovery-stage research scientists involved with the identification of potential biomarkers and formulation of early biomarker plans.

Responsibilities:

  • Collaborate cross functionally with nonclinical, translational and clinical functions to create clinical biomarker plans, and then lead implementation of clinical biomarker plans for Jounce clinical-stage programs

  • Identify robust assay platforms and vendors suitable for clinical sample analysis

  • Develop/transfer assays for clinical biomarkers to appropriate vendors and oversee assay development, fit-for-purpose validation, and report generation

  • Oversee the bioanalytical assay scientist(s) and function including assay development, validation and sample testing for generation of pharmacokinetic, toxicokinetic and immunogenicity data at external CROs to support INDs/CTAs and BLAs

  • In collaboration with clinical operations, ensure clinical sample collection and analysis proceeds smoothly, confirm the quality of the data generated, and oversee generation of sample analysis reports in accordance with agreed timelines

  • Collaborate with the subject matter experts, clinical pharmacology, biostatistics, programming and data management to ensure appropriate data analysis, reporting and interpretation of raw biomarker data, PD and PK/PD analyses.

  • Participate in corporate budget development with accountability for IND-enabling and clinical biomarker and bioanalytical assay budgets.

  • Collaborate with discovery, research and translational functions on proactive biomarker planning and generation of IND-enabling non-clinical data for early-stage compounds.

  • Represent Jounce in companion diagnostic or potential companion diagnostic partnerships to ensure that partnered assay validations meet all relevant regulatory requirements.

  • Participate in planning and authoring of regulatory and clinical documents, posters and publications.

  • Serve as a resource for development of biomarker plans and assays for potential and late-stage discovery and early development candidate-stage programs.

Qualifications

  • Advanced degree (PhD, MD or equivalent) in the biological or medical sciences with at least 10 years of experience in biomarkers and clinical biomarker assay development and implementation

  • A background in oncology or immunology is strongly preferred.

  • Knowledge of and experience with common clinical biomarker assay platforms, including ELISA, flow cytometry, other ligand-binding methods and cell-based ex vivo assays

  • Knowledgeable about requirements for fit-for-purpose, GLP-compliant or CLIA-compliant assay validation and experience applying these standards appropriately based on development stage and biomarker status in the program.

  • Familiarity with submission-level reporting and data quality standards

  • Extensive experience in the selection and oversight of assay vendors to support national and global clinical trials

  • Working knowledge of bioanalytical assay methodology and regulatory requirements for GLP bioanalysis of large molecules and immunogenicity assays

  • Familiarity with genomic and pathology assays and methodologies is desired

  • Experience working on companion diagnostics or medical devices is desired but not a requirement for this position.

  • Excellent collaboration skills

  • A passion for mentoring and developing people

  • Demonstrated success working in a cross-functional matrixed setting

  • Experience setting and managing to specific budget and timelines.

Statement

Equal Opportunity Employer

Jounce Therapeutics is an equal opportunity employer and does not discriminate in its employment decisions on the basis of race, color, national origin, age, physical or mental disability, marital status, religion, creed, sex, or political beliefs. We offer a competitive salary and benefits package. All applicants should be legally entitled to work for any employer in the U.S.

Company Summary

Jounce Therapeutics, Inc. is a clinical-stage immunotherapy company dedicated to transforming the treatment of cancer by developing therapies that enable the immune system to attack tumors and provide long-lasting benefits to patients through a biomarker-driven approach. Jounce currently has multiple development stage programs ongoing while simultaneously advancing additional early-stage assets from its robust discovery engine based on its Translational Science Platform. Jounce's most advanced product candidate, vopratelimab, is a monoclonal antibody that binds to and activates ICOS, and is currently being studied in the SELECT Phase 2 trial. JTX-4014 is a PD-1 inhibitor intended for combination use in the SELECT trial and with Jounce's broader pipeline. Jounce's next development stage product candidate, JTX-8064, is a LILRB2 (ILT4) receptor antagonist shown to reprogram immune-suppressive tumor associated macrophages to an anti-tumor state. A Phase 1 trial evaluating JTX-8064 is planned to begin enrollment in the fourth quarter of 2020. Additionally, Jounce exclusively licensed worldwide rights to JTX-1811, a monoclonal antibody targeting CCR8 and designed to selectively deplete T regulatory cells in the tumor microenvironment, to Gilead Sciences, Inc. For more information, please visit www.jouncetx.com.

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