Sr. Director, Clinical Research Scientist

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

Title: Sr. Director, Clinical Research Scientist

Reports to: Chief Medical and Development Officer

Location: Emeryville, CA (hybrid twice a week) or Remote with west coast hours

Kyverna is recruiting for a Sr. Director, Clinical Research Scientist will conduct and oversee clinical research studies in accordance with GCP, company policies, and regulations.  The role will develop, lead, and maintain study protocols, informed consent forms, and other study documents through cross-functional collaboration including physicians, biostatisticians, and data managers for successful execution of clinical trials.  In addition, this position will be responsible for mentoring and potentially managing staff members for clinical research processes and procedures.  All this will underpin assessing and improving processes and procedures to ensure the highest quality of clinical research. The ideal candidate will contribute to our goals of navigating what’s next in synthetic biology, immunology and cell engineering while living our core values: bring intellectual rigor, elevate each other, and stay true to why.  

• Clinical Planning:
• Strategically contribute to and participate in the clinical strategy and clinical plans including study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
• Collaborate with clinical research staff in the design, conduct, and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions).
• Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.

• Clinical Research/Trial Execution and Support:
• Plan, collaborate on and review scientific content of clinical documents such as clinical trial protocols, clinical study reports, and BLA submissions (for example, annual reports) according to the agreed-upon project timeline.
• Provide strategic oversight and input into informed consent documents.
• Review and approve risk profiles to ensure appropriate communication of risk to study participants.
• Participate in investigator identification and selection, in conjunction with clinical teams.
• Ensure that the operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with GCP and local laws and requirements.
• Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of deviations and adverse events, in alignment with corporate patient safety policies and procedures.
• Participate in the Publication Steering Committee (PSC), and the DRIVE meetings and review publications, as requested.

• Scientific Data Dissemination/Exchange:
• Participate in reporting clinical trial data in Clinical Trial Registry activities.
• Knowledge and understanding of the medical data generation and dissemination strategies of the portfolio and actively address unsolicited scientific information needs of external healthcare professionals according to the guidelines above.
• Prepare or review scientific information in response to customer questions or media requests.
• Support data analysis and the development of slide sets (through reviewing and/or approval) and publications (abstracts, posters, manuscripts) as well as development of scientific data dissemination, and preparation of final reports and publications as well as preparation of regulatory reports.
• Active membership and participation in advisory committees.

• General:
• Provide strategic guidance and support to the management team, in the preparation and administration of the budget.
• Actively set and meet individual professional development goals and contribute to the development of others and actively participate in recruitment efforts.
• Participate in active coaching by providing timely and constructive feedback to co-workers, and others on the medical team, in the spirit of development, increased team effectiveness, and cohesiveness.
• Stay current with developments in the field of clinical research and incorporate new methodologies and technologies into study design.
• Represent the company at scientific conferences and meetings, and present study results to external audiences.

• Advanced science degree required (PhD, PharmD, MD, RN, NP, PA or equivalent)
• Cell therapy experience.
• 12+ years’ experience within clinical research and trial management.
• 4+ years’ management experience preferred.
• Experience with Investigator Initiated and/or Collaborative research trials
• Ability to deliver scientific and clinical presentations to a variety of audiences.
• Knowledge of and compliance with local laws, regulations, global policies and procedures with respect to data dissemination and interactions with external healthcare professionals. 
• Prior experience in rheumatology, neurology or hematology preferred.
• Excellent verbal, written and interpersonal communication skills.
• Independently manage projects and work well with cross-functional team members to achieve corporate and department objectives.
• Demonstrated positive, collaborative relationships with all internal and external stakeholders.
• Ability to work in a fast-paced and ever-changing environment, as well as the proven track record of working effectively in diverse teams involving multi-functional disciplines
• Proven ability to develop internal relationships in a highly matrixed environment, as well as external relationships with KOL’s and industry experts.
• Must be able and have flexibility to travel all for medical congress coverage, exhibit booth staffing as well as support team with clinical site visits depending on business needs.
• Ability to maintain current licensure and obtain appropriate certifications to allow access to customer site visits, conference attendance and international travel requirements.

The base salary range for this position is $260,000 to $300,000 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 that may include but are not limited to quality and length of experience, education, geographic location and alignment with market data. 

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 identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets