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Vice President, Clinical Development

Company: Kyverna Therapeutics
Location: Berkeley
Posted on: September 12, 2020

Job Description:

Vice President Clinic Management Jobs in Berkeley, CA

Kyverna is a cell therapy company engineering and developing a new class of curative living medicines for inflammatory and autoimmune diseases. Kyverna reprograms T cells to target, selectively suppress, and eliminate autoreactive immune cells. Using advanced cell engineering techniques, Kyverna designs synthetic cell therapies to treat autoimmune diseases. Located in Berkeley, California, Kyverna is backed by top investors including Westlake Village BioPartners and Vida Ventures. Additionally, Kyverna recently announced an R&D collaboration with Gilead Sciences.. In anticipation of the Company’s growth, Kyverna seeks to recruit a Vice President, Head of Clinical Development. In this role, and in collaboration with the Research organization the incumbent will be responsible for the design, execution and oversight of first-in-human clinical trials in addition to growing the development organization when nearing IND submission. Full understanding of tenets of FIH studies (e.g. dose selection rationale, biomarker plans, ..) and the relevant compliance framework for clinical development activities are essential, as is entrepreneurial drive to help the organization succeed, and passion for science and patients.. Responsibilities. Reporting directly to the CEO, the candidate will:. · Lead clinical science aspects of design, execution, interpretation and reporting of early (first in human) stage clinical trials. · Collaborate with scientists and technical experts to integrate cellular therapy specific aspects of PK/PD, diagnostic, and biomarker plans into the overall clinical development strategy. · Contribute clinical leadership and expertise in the development of study protocols and clinical study reports, study medical monitoring, safety reporting, regulatory documentation and interactions, and other clinical deliverables. · Collaborate with academic scientists, clinical experts, and study investigators. · Represent and advocate for the project in internal and external venues. · Clinical leadership for business development and partnership activities as needed. · Act as a champion for high standards of compliance, ethics and safety, and putting patients first. Requirements. · MD or MD-PhD. Alternately, PhD with relevant clinical development experience will be considered. · 10+ years’ industry clinical development experience leading cross-functional development teams. · Sub-specialization and/or clinical development experience in autoimmune diseases is highly desirable. Candidates with demonstrated experience in other immune-driven diseases (e.g. hematopoietic stem cell transplantation, immuno-oncology) will be considered. · Experience with cell therapy and/or regenerative medicine advanced therapies highly desirable. · Demonstrated capacity to think creatively when addressing complex situations. · Demonstrated excellence and experience in first-in-human clinical development including the design, execution of first in human trial and submission of INDs. · Multi-tasker able to anticipate biometrics, regulatory, clinical operations, development sciences, pharmacovigilance, and other development needs (leveraging internal or external consultant resources) to ensure successful program delivery. · Ability to communicate effectively with clinical, biomarker, biostatistical, and pre-clinical scientists, including peer to peer interactions with academic scientific experts. · Demonstrated success in engaging regulatory agencies. · Drug safety experience is a plus. · This position may require travel up to 15 % of the time. ----. Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets. Get alerts to jobs like this, to your inbox.

Keywords: Kyverna Therapeutics, Berkeley , Vice President, Clinical Development, Other , Berkeley, California

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