You haven't searched anything yet.
Kyverna Therapeutics is a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases. The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate the 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.
Kyverna is recruiting a highly motivated Director of Clinical Quality to establish and lead our GCP/GLP/PV quality efforts and advance our mission to free patients from the siege of autoimmune disease. As a Leader in the Quality Function, this individual will build and lead a Quality Unit focusing on clinical quality oversight for our clinical development programs both in the US and internationally, including oversight of contract labs supporting the clinical studies and non-clinical studies, ensuring our adherence to regulatory requirements, and maintaining the highest standards of quality in our clinical operations.
This position will collaborate with internal clinical and nonclinical functions and external parties including consultants, contract auditors, CROs and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for all programs. Additionally, this position will independently manage domestic and international risk-based audits of investigator sites, study documents, databases, vendors, partners, and internal systems in compliance with GCP, GLP, and Company policies and procedures; assess impact of audit findings on subject safety, data integrity, and business operations. The Director will support a culture of sustainable compliance; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready.
The ideal candidate will have deep experience in Clinical Quality oversight of biopharmaceutical products with additional experience in managing trials involving autologous or allogeneic genetically modified cell therapies. They will contribute to our goals while living our core values: Bring Intellectual Rigor, Elevate Each Other, and Stay True to Why.
If you are passionate about transforming the lives of patients and making significant contributions to the field of cell therapy, we invite you to join us; and together we can drive forward innovative treatments and improve the standard of care to tame autoimmune diseases
\nResponsibilities:
The salary range for candidates residing in California for this position is $195,000 USD to $230,000 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
Full Time
$242k-291k (estimate)
07/01/2023
06/25/2024
kyvernatx.com
Emeryville, CA
<25
The job skills required for Director, Clinical Quality include Leadership, Collaboration, Coordination, Quality Improvement, Problem Solving, etc. Having related job skills and expertise will give you an advantage when applying to be a Director, Clinical Quality. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Director, Clinical Quality. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Director, Clinical Quality positions, which can be used as a reference in future career path planning. As a Director, Clinical Quality, it can be promoted into senior positions as a Chief Medical Officer that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Director, Clinical Quality. You can explore the career advancement for a Director, Clinical Quality below and select your interested title to get hiring information.