Clinical Scientist/Associate Director
Emeryville, CA /
Clinical /
Full Time
/ On-site
Kyverna is a cell therapy company engineering and developing a new class of curative living medicines for inflammatory and autoimmune diseases. Kyverna is navigating what’s next in the synthetic biology, immunology and cell engineering to create a new class of T-cell therapies programmed to target and selectively modulate the underlying causes of autoimmunity. Join the front lines of a cell therapy revolution where scientists, industry veterans and healthcare visionaries are creating a new class of living medicines for autoimmune disease.
The Clinical Scientist is responsible for supporting the medical and scientific rigor in development, conduct and reporting of clinical studies across all stages of drug development. Responsible for medical and scientific quality in the design, planning, initiation and successful completion of clinical trials for therapeutics in all phases of company pipeline in clinical development. The ideal candidate will contribute to our goals of navigating what’s next in clinical development of T-cell therapies while living our core values: Bring Intellectual Rigor, Elevate Each Other, and Stay True To Why.
Responsibilities:
- Support and play a key role in developing clinical research documents, including clinical study synopses, protocols, CRFs, informed consent templates, clinical study reports, feasibility assessments, and site selection strategies, in collaboration with the Medical Lead, Clinical Operations team and study statisticians.
- Work closely with Medical Lead in supporting the design, launch, ongoing conduct, and completion/database lock of studies, including providing general scientific input, supporting data review, etc.
- Provides scientific input to clinical studies with ability to review competitive landscape, comparative trials, and focus study design and other elements to intended objectives of trial.
- Write, edit and review medical and scientific elements of clinical research, operational, and regulatory documents to ensure accuracy, consistency with standard of care, logistical ease, and internal consistency. This may include primary ownership of documents such as clinical trial protocol, synopsis, and associated amendments.
- Ensure validity, accuracy, relevance and completeness of medical and scientific content in clinical research and regulatory documents, such as clinical study reports, investigator’s brochure, etc.
- Establish and maintain quality relationships with leading investigators and clinical sites on assigned protocols in collaboration with Medical Lead and Clinical Operations team.
- Supports operational teams and medical lead with identification and deployment of appropriate measures to maintain speed of recruitment, site enthusiasm and motivation of site staff in collaboration with Clinical Operations team.
- Incorporate relevant recent advances in the field into clinical research.
- Provide medical and scientific advice to the Clinical and Regulatory teams, including literature searches on relevant topics and questions.
- Educate investigators and site teams on the medical and scientific aspects of assigned studies.
- Contribute to the development of global regulatory strategies.
- Participate in development of publication strategies, writing and editing of draft presentations and manuscripts and interface with investigators, in conjunction with medical writing, medical lead, and other team members.
- Establish and maintain communication with prominent clinical investigators relevant to assigned projects. This can include organizing advisory boards (scheduling meetings, identifying ad board members, setting up agenda, slides, etc, in conjunction with medical lead).
- Attend appropriate scientific meetings to maintain awareness of research activities.
- Share scientific knowledge with the organization during continuing education sessions and CRA and vendor trainings, at an adapted level of understanding.
Requirements:
- PhD, PharmD or MD with demonstrated industry experience in clinical research, including protocol design and execution, minimum 5 years preferred, or an equivalent combination of education and experience. Specific expertise and experience in cell therapy/CAR-T trials, as well as studies in autoimmune disease indications is preferred.
- Demonstrated track record of scholarship, independent research funding, publication and membership in scholarly societies OR proven track record of successful protocol development, execution and reporting in industry.
- Excellent interpersonal communication, collaboration, organization, and presentation skills.
- In-depth understanding of the clinical development process and its intricacies.
- Solid understanding of clinical trial design, biostatistics and data analysis.
- Familiarity with ICH and GCP.
- Strong project management skills.
- Ability to produce high quality work in a small company environment.
- Ability to understand, influence, collaborate and lead in a diverse team-based organization.
- Competence with standard office computer software tools.
- Ability to align activities with company objectives.
- “Roll-up-the-sleeves” attitude and ability to rise to challenges in a dynamic, clinical stage biotech company.
The base salary range for candidates residing in California for this position is $135,000 USD to $157,000 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, relevant experience, tenure, skills and abilities, geographic location, 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
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
