The Sr. Manager will lead the design, qualification, and technology transfer of clinical and commercial packaging and labeling configurations across a global CDMO network. They are responsible for ensuring regulatory compliance, maintaining chain of identity, and overseeing validation strategies for temperature-controlled systems.
The Associate Director leads the design and implementation of a risk-based Quality Management System aligned with ICH GCP E6(R3) standards. They are responsible for overseeing controlled documentation, vendor quality, TMF health, and ensuring inspection readiness across GxP functions.
The Associate Director will lead the planning, execution, and oversight of global clinical trials while managing CROs and cross-functional teams. They are responsible for ensuring study quality, compliance with regulatory standards, and effective budget and resource management throughout the clinical development lifecycle.
The Senior In-House Clinical Research Associate supports the planning, execution, and oversight of clinical trials while serving as a key partner to clinical sites and vendors. Responsibilities include monitoring oversight, study documentation development, and ensuring compliance with regulatory standards and SOPs.
The Senior Director will provide strategic and operational leadership for global apheresis activities supporting clinical and commercial cell therapy programs. They are responsible for building a high-performing team and establishing a network of qualified collection centers to ensure regulatory compliance and manufacturing demand.
The Logistics Coordinator manages the booking, tracking, and communication of patient and manufacturing material shipments across the supply chain. This role acts as a central point of contact to ensure compliant and timely delivery while escalating potential risks to patient treatment schedules.
The Associate Director, GxP Auditor is responsible for planning and conducting quality audits of internal operations, CDMOs, and clinical sites. They also act as a subject matter expert to manage quality projects, lead investigations, and ensure compliance with regulatory requirements.
The manager will oversee the generation and quality control of clinical and regulatory documentation to ensure compliance with global standards. They will also mentor team members on technical writing best practices and manage document preparation timelines across various clinical programs.
The Associate Director will provide end-to-end leadership for clinical data management across assigned studies, from protocol review through database lock and regulatory submission. They will oversee CROs and vendors while ensuring high-quality, analysis-ready data in compliance with GCP and regulatory standards.
The Senior Vice President will lead the Sales and Marketing organization to prepare for the commercial launch of rese-cel in dermatomyositis. This role involves developing commercial strategies, building high-performing teams, and ensuring operational readiness across all functional areas.
The Director of Validation leads the strategic development and implementation of laboratory validation programs for equipment and computerized systems to ensure GxP compliance. This role oversees the transition from clinical-stage development to commercial launch, ensuring inspection-readiness for BLA submissions.
Responsible for maintaining GLP compliance across laboratory operations and developing quality control processes to ensure data integrity. The role involves conducting internal audits, managing controlled documentation, and supporting regulatory inspections.
The role is responsible for defining and managing the product pipeline and research strategy to address unmet medical needs and market opportunities. It also supports the Chief Business Officer in executing business development transactions, including licensing and research collaborations.
Provide operational oversight of key suppliers and CDMOs to ensure the steady supply of products and services for patients. Manage supplier governance, track KPIs, and lead cross-functional teams to resolve operational issues and implement CAPAs.
Coordinate end-to-end international shipments of patient materials and ensure strict compliance with trade regulations and chain-of-custody requirements. Manage relationships with logistics providers and CDMOs to support the global vein-to-vein supply chain.
Manage end-to-end supply planning for cell and gene therapy, including 36-month supply plans and biorepository forecasting. Coordinate with CDMOs and internal stakeholders to optimize supply chain efficiency and support the S&OP cycle.
Lead the development and execution of the company's investor relations and external communications strategy to shape the corporate narrative. Partner with executive leadership to translate scientific progress and clinical milestones into compelling messaging for the investment community.
Lead the strategic development and execution of the field medical organization to support cell therapies for autoimmune diseases. This includes building and mentoring an MSL team, managing KOL relationships, and aligning field insights with broader medical and commercial strategies.
Manage day-to-day clinical sample activities, ensuring accurate tracking, handling, and documentation throughout the study lifecycle. Collaborate with clinical teams and external vendors to maintain sample integrity and compliance with regulatory requirements.
The Director, Clinical Scientist will lead the clinical development of CAR-T cell therapy programs by overseeing study design, execution, and data interpretation. They will also manage regulatory documentation and collaborate with cross-functional teams to ensure scientific integrity and program success.
The Vice President of Regulatory Affairs will lead the global regulatory strategy and execution for an advanced cell therapy product development program, ensuring compliance and guiding interactions with global health authorities like the FDA and EMA. This role involves overseeing the preparation and submission of key regulatory documents such as INDs, CTAs, and BLAs/MAAs, while serving as a primary regulatory advisor to executive leadership.
The Senior In-House CRA supports the planning, execution, and oversight of clinical trials, acting as a key operational partner to clinical sites, CROs, and vendors. This role ensures high-quality trial conduct, strong external relationships, and inspection-ready documentation throughout the study lifecycle.
This physician leader will provide medical oversight and leadership for cell therapy programs in autoimmune diseases, collaborating across clinical operations, regulatory, and manufacturing functions while liaising with investigators and Health Authorities. Key duties include formulating study designs, leading protocol development, ensuring operational efficiency through CRO/vendor management, and participating hands-on in all aspects of clinical study conduct, data review, and reporting.
This role involves serving as the Regulatory Lead for the pivotal program leading to BLA submission, responsible for developing and executing regulatory strategies to support the development and commercialization of cell therapy products. Key duties include managing all regulatory aspects through pivotal studies, preparing applications, managing health authority meetings, and ensuring compliance across global agencies like the FDA and EMA.
This role involves managing the end-to-end process for scientific publication planning, ensuring compliance, and collaborating with cross-functional teams to develop manuscripts, abstracts, and presentations. Responsibilities also include managing external vendor execution, budget oversight, and developing comprehensive scientific engagement and congress plans.
