Senior Director, Clinical Research Scientist

Summary

Join Kyverna Therapeutics, a clinical-stage biopharmaceutical company, as a Sr. Director, Clinical Research Scientist. This role involves overseeing clinical research studies, developing study protocols, and collaborating with cross-functional teams. You will mentor staff, assess research processes, and contribute to clinical trial execution. The ideal candidate possesses an advanced science degree, extensive clinical research experience, and strong leadership skills. This position offers a hybrid or remote work option and a competitive salary.

Requirements

• Advanced science degree required (PhD, PharmD, MD, RN, NP, PA or equivalent)
• Cell therapy experience
• 12+ years’ experience within clinical research and trial management
• 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
• 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

Responsibilities

• 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
• 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
• 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
• 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

Preferred Qualifications

• 4+ years’ management experience preferred
• Prior experience in rheumatology, neurology or hematology preferred

Benefits

• $260,000 - $300,000 a year
• Hybrid twice a week or Remote with west coast hours