The Accounts Payable Specialist will manage the full invoice lifecycle, including vendor onboarding, invoice processing, and discrepancy resolution within the Coupa platform. They will also support month-end close activities, reconcile accounts, and ensure compliance with tax regulations and company policies.
The Director of Training will design and lead a comprehensive global training strategy for Medical and Commercial field teams focused on cell therapy assets. This role involves building scalable onboarding, certification, and continuous learning programs while ensuring compliance with regulatory standards.
The Senior Manager will independently author and finalize complex regulatory documents to support clinical development programs and FDA interactions. They will collaborate with cross-functional teams to ensure scientific accuracy and compliance with regulatory standards.
The Executive Director, Lifecycle Lead is responsible for driving integrated asset strategies across the full product lifecycle, from early research through commercial launch. This role coordinates cross-functional teams to ensure alignment in clinical development, manufacturing, regulatory, and commercial objectives.
Develop and lead the enterprise compliance program to transition the company from clinical to commercial stage. Establish the vision, strategy, and governance to manage regulatory and ethical risks across the organization.
Lead the strategy and execution of transitioning the Trial Master File function from an outsourced to an in-house model. Ensure all study TMFs are inspection-ready and aligned with global regulatory expectations through governance and quality control.
Lead the company's technology strategy and transition from a development-stage biotech to a commercial organization. Oversee enterprise applications, cybersecurity, infrastructure, and GxP validation while partnering with cross-functional business leaders.
Lead global regulatory strategy for cell therapy programs from early development through commercial launch and post-approval lifecycle management. Serve as the primary interface with health authorities like the FDA and EMA to negotiate labeling and ensure regulatory compliance.
Lead the development and execution of the U.S. commercial sales and go-to-market strategy for CAR-T therapies for autoimmune diseases. Build and scale a high-performing specialty sales organization focused on treatment center activation and market penetration.
Develop and execute commercial channel infrastructure and strategies to support the delivery of CAR T therapies. Lead partnerships with 3PLs and specialty pharmacies while optimizing gross-to-net performance and ensuring regulatory compliance.
The MSL serves as a field-based scientific expert engaging with healthcare professionals and KOLs to communicate clinical data regarding CAR-T therapy programs. They are responsible for executing territory strategies, supporting clinical trial enrollment, and gathering medical insights to inform internal development.
Serve as the physician lead for CAR T-cell therapy clinical trials in autoimmune disease indications. Oversee medical monitoring of clinical trials and partner with cross-functional teams to ensure alignment on strategy and execution.
