Kyverna Therapeutics
Director, Regulatory Affairs
Kyverna Therapeutics, Emeryville, California, United States, 94608
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 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 a Director of Regulatory Affairs to help advance its mission to free patients from the siege of autoimmune disease. The ideal candidate will contribute to our goals of navigating what’s next in synthetic biology, immunology, and cell engineering to tame autoimmunity.Reporting to the VP of Global Regulatory Affairs, the candidate will build, drive, and direct the company’s regulatory strategy and operations to successfully introduce cellular therapies for autoimmune diseases in the clinic. The ideal individual should be a motivated and creative leader who has a deep understanding of the various regulations overseeing clinical development and experience to match; this includes prospective thinking and problem-solving to anticipate challenges. Experience should include the creation and filing of INDs/CTAs, BLA/MAAs, briefing packages, orphan drug applications, and various other important regulatory documents and associated designations. Experience interacting with the Office of Therapeutic Products (OTP) and/or agency divisions overseeing autoimmune diseases (e.g. DRTM; Division of Neurology), and equivalent Regulatory Agencies throughout the world, is highly desirable. Critical thinking about study designs, forward-thinking about labeling requirements, manufacturing, and scientific knowledge is needed to ensure the company is working in the best interest of providing investigational cell therapies to patients.Responsibilities:
Oversee all program-related regulatory submissions and interactions, including authorship of critical documents as needed with a keen eye towards applying scientific knowledge and business strategy to create robust messages.Manage and directly contribute to all operational aspects of preparing compliant submissions to Regulatory Agencies.Serve as primary interface with FDA and various other competent authorities.Manage regulatory submission timelines in accordance with project plans. Maintain submission tracking information and inform project teams and management on real-time status of business-critical submissions and risk and timeline management.Provide regulatory support for investigator-initiated trials, including reviewing protocols and providing guidance on regulatory requirements.Track and interpret US and international regulatory developments and communicate the impact on Kyverna's development programs.Review product development and in/out-licensing and partnership opportunities.Develop and maintain regulatory policies and procedures to ensure compliance with applicable regulations and guidelines.As needed, interact and assess regulatory work occurring at CROs.Develop short and long-range regulatory strategies for the Company, working closely with both research and development colleagues, to ensure plans are in place for efficient and expedient drug development.Requirements:
7-10+ years' experience in pharmaceutical regulatory activities.Minimum BS or BA in science/technology or an equivalent combination of education and experience.Excellent communication and collaboration skills, including working closely with internal and external team members.Current and strong working knowledge of electronic document and submission standards and requirements applicable to the US regulatory environment and ICH; EMA and other global agencies preferred.Advanced skills in the use of MS Office and eCTD document publishing tools.Experienced in managing web-based content and document management environments.Proven project management skills to support the planning and coordination of regulatory submissions and appropriate regulatory inspections.Ability to work independently and to be innovative in tackling operational challenges.Demonstrated success leading and scaling teams and proven ability to positively impact company culture and demonstrate flexibility in a fast-paced environment.The salary range for candidates residing in California for this position is $230,000 to $270,000 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 geographic location, 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 the 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 identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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Oversee all program-related regulatory submissions and interactions, including authorship of critical documents as needed with a keen eye towards applying scientific knowledge and business strategy to create robust messages.Manage and directly contribute to all operational aspects of preparing compliant submissions to Regulatory Agencies.Serve as primary interface with FDA and various other competent authorities.Manage regulatory submission timelines in accordance with project plans. Maintain submission tracking information and inform project teams and management on real-time status of business-critical submissions and risk and timeline management.Provide regulatory support for investigator-initiated trials, including reviewing protocols and providing guidance on regulatory requirements.Track and interpret US and international regulatory developments and communicate the impact on Kyverna's development programs.Review product development and in/out-licensing and partnership opportunities.Develop and maintain regulatory policies and procedures to ensure compliance with applicable regulations and guidelines.As needed, interact and assess regulatory work occurring at CROs.Develop short and long-range regulatory strategies for the Company, working closely with both research and development colleagues, to ensure plans are in place for efficient and expedient drug development.Requirements:
7-10+ years' experience in pharmaceutical regulatory activities.Minimum BS or BA in science/technology or an equivalent combination of education and experience.Excellent communication and collaboration skills, including working closely with internal and external team members.Current and strong working knowledge of electronic document and submission standards and requirements applicable to the US regulatory environment and ICH; EMA and other global agencies preferred.Advanced skills in the use of MS Office and eCTD document publishing tools.Experienced in managing web-based content and document management environments.Proven project management skills to support the planning and coordination of regulatory submissions and appropriate regulatory inspections.Ability to work independently and to be innovative in tackling operational challenges.Demonstrated success leading and scaling teams and proven ability to positively impact company culture and demonstrate flexibility in a fast-paced environment.The salary range for candidates residing in California for this position is $230,000 to $270,000 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 geographic location, 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 the 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 identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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