Develop and execute strategic account plans across health systems, IDNs, and treatment centers.
Lead treatment center activation, onboarding, contracting, operational readiness, and site certification.
Serve as the primary customer contact for CAR-T/cell therapy operations, logistics, and order management.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients with autoimmune diseases. The company is guided by core values and is committed to transforming the future of treatment for autoimmune disease.
Lead operational execution of cell therapy trials from startup through close-out, managing timelines, budgets, and vendor oversight.
Ensure compliance with regulatory standards including FDA, EMA, and ICH-GCP, and contribute to protocol development and study documents.
Collaborate cross-functionally with clinical operations, data management, regulatory, and manufacturing teams to drive study success.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. They are guided by core values of collaboration and innovation, fostering a culture of ownership and clarity.
Shape and advance the enterprise training strategy and multi-year roadmap for medical and scientific capability building across the Global Development Organization.
Partner with senior and executive leaders to translate organizational priorities into scalable, measurable training programs that strengthen role readiness and scientific excellence.
Provide strategic oversight of learning architecture, certification frameworks, and training effectiveness, ensuring alignment with Medical Affairs strategy and adult learning principles.
Ultragenyx is a biopharmaceutical company dedicated to leading the future of rare disease medicine by challenging the status quo and creating a new model to bring life-changing treatments to patients. The company fosters a supportive and inclusive culture of profound learning and growth, committed to employee well-being and professional development.
Lead all operational and lifecycle management aspects of Regulatory CMC submissions supporting cell therapy development programs.
Develop and execute global regulatory CMC strategies aligned with program objectives and regulatory requirements.
Serve as Regulatory CMC lead on cross-functional program teams, providing strategic regulatory guidance for cell therapy development.
BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases. We are a small, mission-driven company with a rapidly growing, dynamic environment.
Lead end-to-end TMF strategy, including transition from outsourced to in-house operations.
Ensure TMF health and inspection readiness through governance, quality control, and metrics.
Serve as TMF subject matter expert and partner cross-functionally for document flow and compliance.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. The company is guided by core values of collaboration, innovation, and ownership, and is committed to transforming treatment for autoimmune disease.
Lead integrated asset strategy across the full lifecycle, including research, clinical development, and commercialization.
Drive strategic planning for emerging therapeutic platform technologies and evaluate portfolio opportunities.
Ensure alignment across Clinical Development, Manufacturing, Quality, Regulatory, and Commercial teams for late-stage development and launch planning.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by core values like 'Stay True to Why' and 'Collaborate to Accelerate,' they are a committed team transforming autoimmune disease treatment.
Provide sponsor oversight of CMO QC labs and maintain control strategies for investigational cell therapy products.
Manage validation of analytical methods and stability programs to support clinical trials.
Investigate laboratory deviations and ensure risks are managed to resolution.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. Guided by core values of innovation and collaboration, they are a growing company committed to transforming treatment for autoimmune disease.
Develop and manage relationships with Authorized Treatment Centers, driving appropriate utilization of CAR T therapies.
Coordinate cross-functional activities and ensure a seamless customer experience at each account.
Maintain clinical expertise in hematology/oncology and educate stakeholders on Autolus therapies.
Autolus is a biopharmaceutical company advancing innovative T cell therapies for cancer and autoimmune diseases. The company fosters a flexible, diverse, and dynamic environment that promotes creativity, leadership, and teamwork.
Serve as a subject matter expert in stem cell transplantation and cell therapy, fostering deep scientific relationships with key opinion leaders and healthcare providers.
Prepare and manage a territory plan, engage with field team members to support treatment center authorization and adverse event reporting.
Gather and communicate actionable scientific insights from congresses and stakeholder interactions to inform medical strategy and evidence generation.
Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to improve outcomes for blood cancer patients undergoing stem cell transplants. It maintains a start-up culture of camaraderie, leadership by example, and a passion for science and compassion for patients.
Develop and implement global CMC regulatory strategies for biologic and combination products.
Prepare and manage CMC submissions, briefing documents, and health authority meeting packages.
Serve as the CMC Regulatory lead on cross-functional project teams and support health authority interactions.
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. The company is a small, dynamic organization with a collaborative culture and a strong focus on regulatory excellence.