Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine whatâs possible.
Title: Sr. Director, CMC Program Management
Reports to: SVP, Clinical and Development Operations
Location: Remote with up to 20% travel
Summary
The Sr. Director of CMC Program Management will support our CMC and technical operations teams by providing program and project management expertise for a candidate cell therapy, guiding activities supporting the program through late phases of drug development including activities to support product licensure. This is a cross-functional role that will integrate all CMC aspects of a cell therapy program, including Technical Development, Manufacturing, Quality, Supply Chain, CMC Regulatory, and others.
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Responsibilities- Oversee highly complex early and late phase CMC programs and high-profile partnerships critical to the success of the company.
- Develop and manage highly complex integrated CMC program plans, identify critical path activities and ensure milestones are identified and timeline risk is managed.
- Provide oversight and accountability for the team member responsible for managing one or more external suppliers of LVV or Cell Drug Product, ensuring effective execution and alignment with Technical Team priorities.
- Create and leverage appropriate project management tools to focus teams, facilitate decision making, manage risk, and ensure risks are tracked and communicated clearly within teams, to external stakeholders, and TechOps and Program leadership.
- Partner with TechOps Leadership and finance to develop and manage highly complex program budgets, perform detailed budget analysis, and guide resourcing decisions.
- Ensure effective communication and stakeholder management at all levels of the organization, including project teams, external CDMO partners, and TechOps and Program leadership.
- Lead the interfaces between functional areas and with external partners to ensure effective handoff and communication between functional teams both internally and with partners to execute on important program milestones.
- Ensure on time and in full delivery of CMC activities to support all regulatory milestones including CMC deliverables for drug licensure application. Effectively communicate with project team members, program management colleagues, Senior Leadership Team, Functional Heads, and key stakeholders.
- Help the program management team improve PM tools for project governance and program timelines, as well as the communication of program KPIs, risks, and achievements.
- Facilitate and improve program governance with the Senior Technical Leadership Team through dashboards, agendas, and clear communication
- Drive efficiency and prioritization by helping TechOps balance workload across program teams, strategic initiatives, and routine operations.
- Manage one or more direct reports, with the potential for more. Mentor junior project manager(s) to ensure commitment, collaboration and professional development
- Provides leadership to the CMC program team and functional areas to anticipate and identify sophisticated program issues, which pose a challenge to achieving strategic goals. Implements plan to resolve such issues.
- Identifies and anticipates CMC-related risks/constraints to timing and resources and proactively communicates/escalates
Requirements- Bachelorâs degree and 15+ years of program or project management experience supporting drug development is required.
- An advanced degree such as a PhD, MS, or MD and/or formal project management certification (e.g., PMP) is preferred.
- Program/Project management supporting drug development is required.
- Direct experience working with in a Technical Operations or CMC Program Management team is required.
- Exceptional communication skills (in person and written word) and the ability to interact with a diverse group of individuals.
- Extensive experience managing and partnering with Contract Development and Manufacturing Organizations in the Cell and Gene Therapy space. Must have experience working on the sponsor side in Cell and Gene Therapy organizations; prior experience on the supplier side is considered a strong plus.
- Experience with gene or cell therapy development programs required.
- Experience applying the principles, concepts, practices, and standards of project management for drug development.
- The ability to understand and communicate scientific and business elements associated with Kyvernaâs engineered T cell therapies is a must.
- Strong skills in management of external stakeholders and ability to influence and guide them toward decisions and outcomes that support Kyvernaâs goals.
- Excellent interpersonal skills, ability to develop relationships with key stakeholders, good conflict management skills.
- Proven ability to proactively identify risks and drive resolution of issues.
- Proven track record for delivering projects on time and in full including release of product and regulatory milestones (i.e new drug and biologics licensure applications)
- Results and detail-oriented; self-motivated, ability to work with minimal supervision.
- Ability to perform and be adaptive in a fast-paced environment under tight deadlines.
- Strong analytical and problem-solving capabilities.
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The national base salary range for this position is $235K-$270K annually. This salary range is an estimate of what we reasonably expect to pay for this 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. This position is also eligible for bonus, benefits, and participation in the companyâs stock plan.
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