Director, Clinical Research Scientist
Remote
Clinical /
Full Time /
Remote
Kyverna is seeking a highly motivated Director, Clinical Research Scientist. This position will play a pivotal role in providing scientific, clinical, and operational expertise to support clinical development programs. This position will actively contribute to the strategic design, execution, and monitoring of clinical trials, ensuring scientific rigor and operational excellence. Working as a key member of cross-functional study teams, this role will assist in the interpretation of complex data sets and facilitate the clear communication of findings to internal and external stakeholders. 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.
Title: Director, Clinical Research Scientist
Location: Remote Eligible
Responsibilities
- Clinical Strategy & Program Development
- Lead to the creation of clinical study protocols, ensuring alignment with scientific objectives, regulatory requirements, and operational feasibility.
- Participate in the development and refinement of program-level strategies and clinical development plans for assigned programs.
- Contribute to clinical planning activities, including study start-up meetings, investigator training, and provision of relevant scientific information to site personnel.
- Collaborate with clinical research staff in the design, conduct, and reporting of local and global clinical trials, including sample size determination, patient commitment, timelines, and governance review interactions.
- Regulatory & Scientific Documentation
- Draft, review, and contribute to high-quality scientific and regulatory documents such as IND applications, amendments, Investigator Brochures, clinical study reports, BLAs, and other Health Authority submissions.
- Provide strategic oversight and input into informed consent documents and risk communication to study participants.
- Ensure operational compliance with GCP, corporate policies, and applicable local regulations, including documentation of study initiation and conduct requirements.
- Study Execution, Data Monitoring & Safety Oversight
- Monitor, review, and synthesize safety and efficacy data from ongoing studies, escalating key findings and contributing to data-driven decision-making.
- Oversee patient safety throughout the study, tracking and following up on deviations and adverse events in accordance with corporate safety procedures.
- Participate in investigator identification, selection, and engagement, in collaboration with clinical teams.
- Support operational teams and CRO partners in the execution of clinical trials to ensure quality, compliance, and adherence to timelines.
- Cross-Functional & External Collaboration
- Represent Clinical Development on internal project teams to ensure integration of scientific and clinical perspectives at all stages of drug development.
- Build and maintain strong relationships with external experts, consultants, and key opinion leaders to inform study design, data interpretation, and awareness of emerging trends.
- Serve as a primary liaison for project teams, CROs, Clinical sub-teams, and other internal and external partners.
- Scientific Communication & Data Dissemination
- Serve as the clinical lead for the development of study-related scientific content, including abstracts, posters, oral presentations, and manuscripts for publication.
- Support data analysis, slide set development, final reports, regulatory reports, and clinical trial registry activities.
- Respond to unsolicited scientific information requests from healthcare professionals and media in alignment with corporate guidelines.
- Competitive Intelligence & Scientific Engagement
- Maintain up-to-date knowledge of the competitive landscape, especially assets with similar mechanisms of action and evolving standards of care in relevant therapeutic areas.
- Represent the company at scientific conferences, advisory boards, and external meetings, presenting study results and engaging with the scientific community.
Qualifications
- BS degree in a scientific or life sciences discipline; Advanced degree, Pharm.D. or Ph.D. strongly preferred.
- 10+ years of experience in drug development; alternative, relevant experience.
- Prior experience in CAR-T or Cell/Gene Therapy, neurology, dermatology and/or autoimmune strongly preferred.
- Proven ability to work independently, manage multiple priorities, and thrive in a fast-paced, dynamic environment.
- Exceptional written and oral communication skills, with the ability to translate complex scientific data into clear, actionable
- Lead projects and work well with cross-functional team members to achieve corporate and department objectives.
- 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.
The salary range for this position is from $200,000 to $240,000 USD 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 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.
