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Director of Translational Medicine

Kali Therapeutics

About Us Kali Therapeutics embodies transformation and renewal, inspired by the Hindu goddess Kali, symbolizing power and rebirth. Focused on groundbreaking advancements in immunotherapy, Kali Therapeutics specializes in T-cell engagers and other innovative therapies that address high unmet medical needs. About The Role Reporting to the Chief Medical Officer, the (Associate/Sr) Director of Translational Medicine is responsible for leading translational and biomarker efforts across therapeutic portfolio with multiple biologics in therapeutic areas including autoimmune and oncology. You will help provide strategic and scientific leadership to define the translational vision, ensure biomarker‑driven clinical development, and integrate deep immunologic understanding into program strategy. You will also manage external vendors (e.g. CROs, biolabs) to ensure biomarkers’ assessments and data delivery from global clinical studies. You will serve as a translational science leader and will partner closely with Clinical Operations, Clinical Development, Drug Discovery, Regulatory, and CMC teams to ensure translational excellence and mechanism‑driven insights across the development lifecycle. You may also collaborate with external partners to develop and align translational strategies for clinical studies. What You'll Do: Lead end to end translational biomarker strategy for clinical programs, ensuring biomarker driven clinical development aligned to program timelines. Oversee development, validation, and implementation of biomarker assays, including immune monitoring, tumor biology assessments, and patient stratification tools. Collaborate with clinical and medical leads to design and execute clinical trial design and biomarker strategies that advance mechanistic understanding and inform dose optimization and patient selection. Act as the primary translational science lead on cross functional development teams, influencing clinical strategy through biomarker and mechanistic insights with clarity and scientific authority. Drive scientific innovation and identify novel biomarker opportunities to support patient stratification, pharmacodynamics, resistance mechanisms, and combination therapy rationale. Prepare and present clear, data driven presentations for internal leadership, key opinion leaders, regulatory authorities, and external collaborators. Manage CROs responsible for assay development and execution, including scope of work, budget planning, audits, quality oversight, and performance management. Oversee central lab operations and biospecimen management, ensuring compliant handling, storage, tracking, and availability of samples for translational analysis. Build and maintain productive relationships with cross functional team members, key opinion leaders, investigators, and external partners, fostering a culture of collaboration, accountability, and scientific rigor. What You'll Bring: PhD, or equivalent in Immunology, Oncology, Translational Medicine, or related discipline. 5+ years of industry experience with increasing responsibility in translational medicine, biomarker development, or related fields. Experienced in managing external CROs and vendors, and leading central lab operations and biospecimen management. Strong working knowledge of GLP/GCP and biomarker related regulatory expectations, including contributions to clinical protocols, investigator brochures (IBs), IND, lab manuals, and clinical study reports (CSRs). Strong data analysis experience with biomarker endpoints and biological datasets, and proficiency with platforms such as Spotfire. Excellent presentation and communication skills with a demonstrated ability to translate complex data into decisive recommendations and engage internal leadership, investigators, and external stakeholders. Proven leadership in matrixed team environments with the ability to influence without authority and align scientific priorities across cross functional teams. Comfortable operating in a fast moving, collaborative biotech environment. Kali is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. At Kali we engage in equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. We take care of our employees with a competitive benefits package that provides medical, dental, and vision coverage for employees and their dependents, as well as 401(k) plans.

Vacancy posted 3 days ago
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