Senior Director, Technical Program Lead CMC

Summary

Join Kyverna Therapeutics, a clinical-stage biopharmaceutical company, as their Sr. Director, Technical Program Lead. This role involves leading a technical program strategy team, creating product technical realization roadmaps, and implementing CMC strategies from clinical stages to commercialization. The ideal candidate will possess extensive experience in the pharmaceutical industry, specifically with cell therapies, and will collaborate with various stakeholders to ensure successful project execution. The position offers a hybrid or remote work option and a competitive salary.

Requirements

• Advanced degree in chemistry, pharmaceutics, chemical engineering or related field or equivalent experience
• 15+ years’ experience in the pharmaceutical industry
• 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

Responsibilities

• Represent the Technical CMC team on the Program Lifecycle Team; collaborate closely with other Product Lifecycle Team members to define and deliver the project strategy, objectives and plans; ensure that the technical strategy is aligned with the Product Lifecycle Team objectives and corporate goals
• Interact closely with cross-functional technical functions and key stakeholders within the program to ensure alignment
• Provide regular updates to the Product Lifecyle Team and the relevant governance committees; communicate the CMC strategies and activities to external partners as needed
• Ensure the scientific integrity of the technical development process, CMC strategies, and deliverables
• Provide technical oversight and manage the plan for development of key messages and organization of CMC content of regulatory files (IND, IMPD, BLA, MAA, and amendments)
• Compile and track the content, timing and adequacy of responses to Requests for Information
• With the functions, participate in and coordinate activities related to Inspection Readiness making sure the activities and their completion are integrated into the Program plans
• Participate in Health Authority meetings representing the CMC content and strategy
• Participate in strategic meetings evaluating capacity planning, launch readiness
• Ensure 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)
• Supervise team members in a matrix environment as a dotted-line reporting structure
• Establish effective decision-making and risk management processes. Track and communicate these to the Program Lifecycle Team for complete visibility of Program Risks and their remediations
• Anticipate and identify issues, develop contingency and risk mitigation plans, and communicate 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
• Partner with functional area management and seek input from functional area forums and Program Leadership Board (PLB) to ensure that technical expertise is provided and budgeted as necessary
• Contribute to the development of department business initiatives and facilitate their implementation
• Create and manage CMC program-related budget and accrual
• Support Corporate Development in due diligence and partnership efforts

Preferred Qualifications

Prior experience as a TPL

Benefits

• $240,000 - $295,000 a year
• Hybrid or remote work option (with West Coast hours preferred)