Medical Writer
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.
Kyverna is recruiting for a Medical Writer in its Clinical Department to author key scientific and regulatory documents, including protocols, investigator brochures, submission documents, clinical study and safety reports. This individual will work closely across all functions to develop high quality and comprehensive medical and scientific clinical trial documents. 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.
Responsibilities:
- Lead efforts in the planning, writing, reviewing, editing, and finalizing of key clinical study and regulatory documents, including but not limited to protocols, clinical study and safety reports, investigator brochures, clinical regulatory responses, and clinical summaries.
- Provide direction and oversight of activities completed by external/contract medical writers to ensure timely and quality work product.
- Contribute to the strategic planning, authoring, and critical review of scientific data disclosures (e.g., slide presentations, posters and publications).
- Support scientific presentations and publications in peer-reviewed journals.
- Establish, maintain, and build working relationships with all stakeholders collaborating on clinical documentation development (e.g., KOLs and cross-functional colleagues from Clinical, Medical Affairs, GRA, etc.) to ensure quality, accuracy, and timely inputs for scientific publications.
- Utilize best protocol learnings to inform future study design; escalate any recurring protocol issues when necessary.
- Manage protocol amendment process, including authoring and review
Requirements:
- Advanced scientific degree in the life sciences (MS or PhD) with 5+ years or more direct biotechnology or pharmaceutical industry experience in medical writing.
- Experience with preparation of clinical protocols, study reports, IND, IB, NDA/CTD documents or peer-reviewed publications desirable.
- Expert knowledge of US and international guidance and regulations associated with scientific publications.
- Extensive knowledge of drug development process (phase I-IV clinical trials), GCP, CFR, and ICH regulatory requirements and guidelines.
- Ability to interpret scientific content and adapt to varying audiences.
- Ability to manage medical writing for multiple programs with competing timelines and priorities.
- Working knowledge of statistical concepts and techniques
- Adept in working in cross-functional and collaborative settings and foster a learning environment in which colleagues can discuss scientific and medical content.
- Demonstrated problem solving skills, a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
- Able to work both independently and in a team environment.
The salary range for this position is $128,000 USD to $198,000 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.
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
