Senior Director, Clinical Program Management

🕒 5 days ago

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Kyverna Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $85M Series B on 2022-01

Biotechnology • Pharmaceuticals • Science

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The company is pioneering CAR T-cell therapies, leveraging the transformational power of T cells to potentially provide sustained, treatment-free remission for autoimmune conditions. Kyverna's lead CAR T-cell therapy candidate, KYV-101, is advancing through clinical trials targeting various autoimmune diseases, including multiple sclerosis, myasthenia gravis, systemic sclerosis, and lupus nephritis. Their pipeline features innovative chimeric antigen receptor (CAR) T-cell therapies in both autologous and allogeneic formats aimed at B cell-driven autoimmune diseases.

📋 Description

• Translate program strategy into integrated timelines, milestones, and deliverables, ensuring coordination across all contributing functions • Provide Project Management expertise and support to advance Kyverna’s novel engineered T cell therapy programs • Manage one or more highly complex R&D programs and/or high-profile partnerships • Results-oriented accountability for achievement of program timeline and deliverables • Effectively communicate with project team members, Senior Leadership Team, Functional Heads, and key stakeholders • Track and monitor key milestones and decision points to drive delivery of project objectives • Contribute to PMO LT to develop tools for project governance and program timelines, as well as the communication of program KPIs, risks and achievements • Manage the interfaces between functional areas and ensure effective handoff and communication between department functions to execute on important project milestones • Lead cross-functional program management activities supporting autoimmune clinical development programs. • Develop and maintain integrated clinical development plans, timelines, milestones, budgets, and risk management strategies across multiple functional areas. • Drive execution and alignment across Clinical Development, Clinical Operations, Medical Affairs, Biometrics, Safety/Pharmacovigilance, Regulatory Affairs, Manufacturing, and Quality. • Partner with Clinical and Medical leadership to support development strategy, indication prioritization, and lifecycle planning for assigned programs. • Ensure program activities support regulatory milestones including INDs, protocol amendments, global health authority interactions, and potential BLA/MAA submissions. • Partner with Clinical Operations to proactively identify enrollment, operational, and site-performance risks and implement mitigation strategies. • Ensure seamless coordination between clinical and CMC activities supporting cell therapy manufacturing, supply planning, patient scheduling, and treatment logistics. • Facilitate governance meetings, cross-functional team meetings, and executive program reviews. • Collaborate with Clinical Research Scientists and Medical Directors on protocol strategy, clinical endpoints, efficacy measures, biomarkers, and patient-reported outcomes relevant to autoimmune studies. • Support competitive intelligence activities and maintain awareness of evolving autoimmune treatment landscapes, clinical trial designs, and emerging therapies. • Partner with Regulatory and Medical Writing teams to support preparation of briefing documents, regulatory submissions, investigator brochures, and clinical study reports. • Establish and maintain program dashboards, KPIs, risk registers, and governance frameworks to ensure transparency and accountability. • Drive continuous improvement of program management processes, tools, and reporting capabilities. • Support budget forecasting, scenario planning, and resource prioritization across clinical programs. • Mentor and develop program management staff and contribute to building scalable development operations infrastructure.

🎯 Requirements

• A minimum of a BA/BS and 15+ yrs in a Program/Project management supporting drug development is required, and an advanced degree (Ph.D., MS, MD) and/or PM Certification is preferred. • 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 Kyverna’s 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 Kyverna’s 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.

🏖️ Benefits

• Bonus • Benefits • Participation in the company’s stock plan