Sr. Director, Technical Program Lead CMC

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate 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

Title: Sr. Director, Technical Program Lead

Reports to: Chief Technology Officer

Location: Emeryville, CA (hybrid twice a week) preferred or Remote with west coast hours

Kyverna is recruiting a highly motivated Technical Program Lead responsible for leading a technical program strategy team and creating the product technical realization road map including development and implementation of the CMC strategy and planning from clinical stage through commercialization. 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.

The Technical Program Lead works closely with all stakeholders, including Research, Clinical Development, Technical Development, Technical Operations, Regulatory, and Quality, to define and execute the development plan for the Program. Leads the Technical Program Strategy Team and represents the technical function on the Program Lifecycle Team. The TPL also ensures adequate information flow between team members, to functional management, and to governance committees to ensure transparency, informed decision making, and optimal alignment of all technical deliverables with the Project Team strategy, Clinical Development and Commercial plan. He/she is accountable for strategic planning of development tasks, risks, opportunities and milestones and prepares and tracks the budget for the Technical Operations in line with the Program strategy.

Responsibilities

• Represents the Technical CMC team on the Program Lifecycle Team; collaborates closely with other Product Lifecycle Team members to define and deliver the project strategy, objectives and plans; ensures that the technical strategy is aligned with the Product Lifecycle Team objectives and corporate goals
• Interacts closely with cross functional technical functions and key stakeholders within the program to ensure alignment
• Provides regular updates to the Product Lifecyle Team and the relevant governance committees; communicates the CMC strategies and activities to external partners as needed
• Ensures the scientific integrity of the technical development process, CMC strategies, and deliverables
• Provides technical oversight and manages the plan for development of key messages and organization of CMC content of regulatory files (IND, IMPD, BLA, MAA, and amendments)
• Compiles and tracks the content, timing and adequacy of responses to Requests for Information
• With the functions, participates in and coordinates activities related to Inspection Readiness making sure the activities and their completion are integrated into the Program plans.
• Participates in Health Authority meetings representing the CMC content and strategy.
• Participates in strategic meetings evaluating capacity planning, launch readiness,
• Ensures the CMC Team is successful in making progress toward its goals, adheres to timelines and milestones, and executes per approved Project Development Plan and in agreement with license partners (if any)
• Supervises team members in a matrix environment as a dotted-line reporting structure
• Establishes effective decision-making and risk management processes. Tracks and communicates these to the Program Lifecycle Team for complete visibility of Program Risks and their remediations.
• Anticipates and identifies issues, develops contingency and risk mitigation plans, and communicates the potential impact to the relevant governance committees and the Program Lifecycle Team.
• Represent the CMC Team in the development and implementation of lifecycle vision, strategic goals, and objectives associated with large molecule combination products
• Partners with functional area management and seeks input from functional area forums and Program Leadership Board (PLB) to ensure that technical expertise is provided and budgeted as necessary
• Contributes to the development of department business initiatives and facilitates their implementation
• Creates and manages CMC program-related budget and accrual
• Supports Corporate Development in due diligence and partnership efforts

Qualifications

• Advanced degree in chemistry, pharmaceutics, chemical engineering or related field or equivalent experience.
• 15+ years’ experience in the pharmaceutical industry with prior experience as a TPL preferred, combined with a strong technical knowledge of small and/or large molecule process development and a sound knowledge of the drug development process
• Deep knowledge of the development of genetically modified cell therapies
• Proven track record of technical accomplishments
• Demonstrated ability to lead cross-functional teams
• Excellent verbal and written communication skills with success in influencing others in cross-functional areas
• Proven ability to provide strategic input and direction to teams
• Strong ability to influence strategy and priorities across multiple functional areas within and outside of the direct area of responsibility.
• Strong collaborative and relationship-building skills
• Proven ability to work proactively, think strategically and translate strategies into actionable plans
• Strong decision-making skills and strategic thinking ability
• Excellent organizational skills, detail oriented and ability to coordinate and advance multiple project timelines, simultaneously
• Strong initiative and desire to work in a fast paced, team-oriented, dynamic environment, with minimal administrative support

The base salary range for candidates residing in the Northern California Area for this position is $240,000 to $285,000 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 that may include but are not limited to quality and length of experience, education, geographic location and alignment with market data.

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