Kyverna Therapeutics, Inc.
Associate Director, Translational Medicine
Kyverna Therapeutics, Inc., Emeryville, California, United States, 94608
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated.Kyverna is seeking a highly motivated Associate Director of Translational Medicine with significant experience in translation medicine to join our team developing innovative engineered T cell-based therapies for autoimmune diseases. The role will report to the VP of Translational Medicine. The Associate Director will work collaboratively across multiple clinical teams, internal and external, to ensure planning, execution, and positive impact of the translational medicine strategy. The essence of this role is to contribute to our goals of navigating what’s next in the treatment of patients with serious autoimmune diseases with state-of-the-art cell therapy while living our core values: Bring Intellectual Rigor, Elevate Each Other, and Stay True To Why.Responsibilities:
Design and develop innovative biomarker strategies to provide proof of biology, a basis for patient and/or disease stratification and an understanding of the drivers of response to therapy.Serve as a subject matter expert and leader of the clinical biomarker research efforts in testing Kyverna cell therapies in neurology indications, including myasthenia gravis, multiple sclerosis and lupus, among others.Drive clinical biomarker research working with relevant internal functions and external collaborators and contract research organizations (CROs).Collaborate with internal and external scientific experts to interpret biomarker data, present findings within Kyverna and the broader scientific community. Leverage this process and associated learnings to identify novel components of the translational medicine strategy.Lead the efforts within clinical development teams to support clinical biomarker development and implementation.Oversee the development, validation and conduct of clinically applicable biomarker assays at partner CROs to ensure the timeliness and quality of biomarker data.Identify, evaluate and implement novel biomarker platforms, technologies and assays to increase applicability and impact of the translational medicine strategy.Provide scientific and strategic inputs to biomarker and clinical operations in support of biomarker sample collection, shipment, and analysis to ensure the quality, integrity and timeliness of biomarker sample analysis. Ensure compliance with GCLP. Where appropriate, champion the collection and analysis of difficult to collect samples such as tissue biopsies and cerebral spinal fluid (CSF).Contribute to drafting, review and delivery of high quality and scientifically rigorous clinical and regulatory documents (including but not limited to study protocols, lab manuals, informed consent forms, investigator brochure, clinical study reports, and IND/BLA documents)Keep current on relevant scientific/technical literature to apply external knowledge to internal clinical research and development programs. Act as a subject-matter expert within the team to critically evaluate the literature regarding the biology of the therapy and disease indications.Maintain timelines for biomarker data related publication through interaction with Medical Communications and Publication teams as needed. Support these and the clinical team more generally with PI engagement efforts at scientific conferences.Provide oversight and direction to direct reports and matrixed collaborators, as applicable.Adhere to all department and company-wide policies regarding conduct, performance and procedures.Requirements:
Position requires a PhD in cell and molecular biology, immunology, neuroscience or a related field, with a minimum of 3 years related laboratory work and 3 years of clinical research experience in the drug development setting.Specific expertise and experience in translational research with demonstrated strong achievements in the academic and/or industry settings.Experience in a small biotech company environment is preferred. Experience in cell therapy development is highly desired.Additional Knowledge and Skills:
Strong knowledge of immunology and cell biology required. Knowledge of neuroscience is a plus.Ability to analyze and interpret complex, high dimensional datasets including those generated by flow cytometry, next-generation sequencing (NGS), epigenetic analysis and / or proteomics in collaboration with bioinformatics colleagues.Excellent oral and written communication skills. Ability to present translational data clearly and compellingly with the appropriate context and interpretation.Strong organizational, planning, and project management skills with the ability to set and meet deadlines.Eagerness to apply immunology and/or neuroscience knowledge and leadership skills to help optimize the treatment of neurological autoimmune disease with cell therapy.Salary:
$190,000 - $205,000 a year
The salary range for candidates residing in California for this position is $190,000 to $205,000 annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation geographic location, individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.#J-18808-Ljbffr
Design and develop innovative biomarker strategies to provide proof of biology, a basis for patient and/or disease stratification and an understanding of the drivers of response to therapy.Serve as a subject matter expert and leader of the clinical biomarker research efforts in testing Kyverna cell therapies in neurology indications, including myasthenia gravis, multiple sclerosis and lupus, among others.Drive clinical biomarker research working with relevant internal functions and external collaborators and contract research organizations (CROs).Collaborate with internal and external scientific experts to interpret biomarker data, present findings within Kyverna and the broader scientific community. Leverage this process and associated learnings to identify novel components of the translational medicine strategy.Lead the efforts within clinical development teams to support clinical biomarker development and implementation.Oversee the development, validation and conduct of clinically applicable biomarker assays at partner CROs to ensure the timeliness and quality of biomarker data.Identify, evaluate and implement novel biomarker platforms, technologies and assays to increase applicability and impact of the translational medicine strategy.Provide scientific and strategic inputs to biomarker and clinical operations in support of biomarker sample collection, shipment, and analysis to ensure the quality, integrity and timeliness of biomarker sample analysis. Ensure compliance with GCLP. Where appropriate, champion the collection and analysis of difficult to collect samples such as tissue biopsies and cerebral spinal fluid (CSF).Contribute to drafting, review and delivery of high quality and scientifically rigorous clinical and regulatory documents (including but not limited to study protocols, lab manuals, informed consent forms, investigator brochure, clinical study reports, and IND/BLA documents)Keep current on relevant scientific/technical literature to apply external knowledge to internal clinical research and development programs. Act as a subject-matter expert within the team to critically evaluate the literature regarding the biology of the therapy and disease indications.Maintain timelines for biomarker data related publication through interaction with Medical Communications and Publication teams as needed. Support these and the clinical team more generally with PI engagement efforts at scientific conferences.Provide oversight and direction to direct reports and matrixed collaborators, as applicable.Adhere to all department and company-wide policies regarding conduct, performance and procedures.Requirements:
Position requires a PhD in cell and molecular biology, immunology, neuroscience or a related field, with a minimum of 3 years related laboratory work and 3 years of clinical research experience in the drug development setting.Specific expertise and experience in translational research with demonstrated strong achievements in the academic and/or industry settings.Experience in a small biotech company environment is preferred. Experience in cell therapy development is highly desired.Additional Knowledge and Skills:
Strong knowledge of immunology and cell biology required. Knowledge of neuroscience is a plus.Ability to analyze and interpret complex, high dimensional datasets including those generated by flow cytometry, next-generation sequencing (NGS), epigenetic analysis and / or proteomics in collaboration with bioinformatics colleagues.Excellent oral and written communication skills. Ability to present translational data clearly and compellingly with the appropriate context and interpretation.Strong organizational, planning, and project management skills with the ability to set and meet deadlines.Eagerness to apply immunology and/or neuroscience knowledge and leadership skills to help optimize the treatment of neurological autoimmune disease with cell therapy.Salary:
$190,000 - $205,000 a year
The salary range for candidates residing in California for this position is $190,000 to $205,000 annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation geographic location, individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.#J-18808-Ljbffr