Director, Translational Biology

We are seeking a highly skilled and motivated Director - Translational Biology to support mechanism of action elucidation for rilparencel, our autologous kidney cell therapy currently being evaluated in a Phase 3 clinical study, as well as the development of next-generation cell therapies by leading non-clinical disease model study design, execution, & analysis. This role will be responsible for designing & coordinating in vivo translational studies, managing sample logistics, developing analytical assay strategies, and overseeing CRO and academic medical institute partnerships. The ideal candidate will have deep expertise with in vivo model development, chronic & diabetic kidney disease (CKD & DKD), bioanalytical assay design, and multi-site study coordination to drive mechanism of action elucidation, multi-omic data generation & analysis, biomarker discovery, and translational medicine for cell therapy programs.

Responsibilities

• In Vivo Translational Study Design & Coordination:

• Develop & implement in vivo CKD/DKD translational study designs to evaluate cell therapy mechanism of action, engraftment, persistence, efficacy, and safety.

• Collaborate with cross-functional teams to define biomarker strategies, dosing regimens, and readouts to inform clinical development.

• Oversee study execution across internal and external non-clinical research sites.

• Sample Management & Logistics:

• Establish and manage workflows for sample collection, storage, tracking, and shipping across in vivo

• Ensure sample integrity and compliance with quality control standards and regulatory guidelines.

• Coordinate with internal and external stakeholders to optimize sample management for high-throughput multi-omic and bioanalytical assays.

• In Vivo Sample Analytical Assay Design:

• Lead the design and validation of bioanalytical assays (e.g., molecular assays, clinical chemistry, flow cytometry, Luminex, ELISA) to assess pharmacokinetics, pharmacodynamics, and immune responses.

• Develop strategies for multiplex biomarker assessment, cytokine profiling, and kidney & immune cell characterization in xenogeneic disease animal models for human cell therapy evaluation.

• Work closely with research & development colleagues & biometrics teams to integrate multi-omic data from in vivo

• CRO Study Coordination & Oversight:

• Identify, evaluate, and manage CRO partnerships for in vivo translational studies, ensuring scientific rigor, quality, and adherence to timelines.

• Establish best practices for study outsourcing, protocol development, and data transfer from external partners.

• Act as the primary liaison between internal teams and CROs to drive successful execution of translational studies.

• Leadership & Cross-functional Collaboration:

• Collaborate with research & development, bioanalytical, biometrics, clinical, and regulatory teams to translate non-clinical findings into clinical and potency assay strategies.

• Provide strategic insights to guide biomarker selection, patient stratification approaches, and regulatory submissions.

• Mentor and lead junior scientists in translational research best practices.

Qualifications

• Education/Training: D. in Pharmacology, Translational Sciences, Cell Biology, Immunology, Molecular Biology, Bioengineering, or a related field, with 10+ years of industry experience in chronic and/or diabetic kidney disease in vivo translational research and cell therapy.

• Experience:

• Deep mechanistic understanding of chronic & diabetic kidney disease in humans and rodents

• Expertise with in vivo model development, sample management, analytical study design & execution, and biomarker assay development.

• Experience managing CRO relationships, vendor contracts, and outsourced non-clinical studies.

• Strong knowledge of flow cytometry, molecular assays (e.g., qPCR, NGS), clinical chemistry, and immunoassays (e.g., Luminex, ELISA).

• Working knowledge of scRNA-Seq, spatial transcriptomics, single cell epigenomics, CITE-Seq, metabolomics, proteomics, and multi-omic integration.

• Experience working with primary human cells, including kidney and immune cells

• Familiarity with computational & bioinformatics tools for high-dimensional data generation, analysis, & interpretation

• In vitro functional assays, and non-clinical in vivo models of chronic kidney disease & xenogeneic models for human cell therapy evaluation

• Cell therapy discovery, research, & development

• Translational biology & medicine

• Type 2 diabetes

• Regenerative medicine

• Stem cell-derived therapies

• Knowledge:

• Familiarity with regulatory considerations for translational and biomarker studies

• Chronic kidney disease biology & competitive landscape

• Type 2 diabetes biology & competitive landscape

• State-of-the-art single cell -omics methods for data generation, analysis, visualization, & interpretation

• Skills:

• Excellent leadership, project management, and communication skills

• Ability to work in a fast-paced environment and collaborate across disciplines

• Strong team player

• Goal-oriented mindset

• Ability to focus efforts & complete deliverables on-time and on-budget

Certifications/Licenses: Licenses / Certification welcome, particularly around animal husbandry and non-clinical studies

ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

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