CART Scientific Operations Lead

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Supply Chain Manufacturing Job Sub Function: Manufacturing Assembly Job Category: Business Enablement/Support All Job Posting Locations: Toronto, Ontario, Canada Job Description: Janssen Pharmaceuticals, Inc., part of the Johnson & Johnson Family of Companies, is recruiting for a (Bilingual English/French) CAR-T Scientific Operations Lead. The Cell Therapy Scientific Advisor & Operations Lead is a hybrid Medical Affairs role dedicated to supporting CAR-T and cell therapy in Canada. The role combines strategic scientific advising with operational leadership by providing expert scientific and medical support for the therapeutic area, establishing trusted peer-to-peer relationships with KOLs and external experts, contributing to evidence generation and medical strategy, and supporting balanced scientific communication. The role also serves as the primary operational point of contact for CAR-T treatment centres on matters related to the provision of JJIM CAR-T products, connecting medical, commercial operations, supply chain, treatment site, and cross-functional stakeholders to enable a best-in-class customer and patient experience across the end-to-end CAR-T journey. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Essential duties and responsibilities: · Establish and maintain trusted peer-to-peer relationships with KOLs and external experts to collaborate on scientific projects, share balanced scientific data as needed, and support the development of clinical publications in accordance with company policies, applicable laws, regulations, and ethical standards. · Provide strategic scientific support to key stakeholders, including Medical Education, Marketing, Access, Communications, Regulatory Affairs, Medical Affairs, and field-based medical teams. · Contribute to study design, protocol development, interpretation of results, post-hoc analyses, publication planning, and local company-sponsored evidence generation studies within the therapeutic area. · Lead or support execution of the Medical Sciences head office strategy, local clinical trial initiatives, Medical Sciences strategic planning, and yearly business planning activities in partnership with the Medical Director. · Identify emerging scientific and development trends likely to impact the business, develop action plans to address scientific gaps, and identify key opinion leaders for new disease areas aligned to the pipeline. · Lead the development and review of balanced and credible scientific communication materials, including slide presentations for internal and external use, advisory boards, workshops, and post-congress evidence dissemination. · Develop and deliver scientific training for internal partners and the MSL team, including education on CAR-T, cell therapy, clinical evidence, and relevant therapeutic area updates. · Review, analyze, and disseminate medical voice of customer insights to derive strategic implications and develop action plans that support delivery of the medical strategy. · Serve as a rapid deployment medical resource for critical events and special medical projects requiring significant cross-functional integration, and participate in or represent Medical Sciences on special projects as agreed with the Medical Director. · Serve as the primary point of contact for Canadian CAR-T treatment centres for matters related to the provision of JJIM CAR-T products, acting as the connection between commercial operations and medical matters within the local CAR-T medical team. · Manage end-to-end site set-up, certification, qualification, and lifecycle maintenance activities to ensure treatment site and staff readiness to successfully manage cell therapy orders. · Deliver and coordinate upfront and ongoing education and training for treatment centres on systems, protocols, policies, order fulfillment processes, technology utilization, and Health Canada-aligned training materials. · Support treatment centre onboarding to the order management IT platform, assist with case management, verify completeness of intake information, and ensure appropriate stakeholders receive timely and accurate patient safety information. · Inform and support order tracking and operations coordination after order placement, including communication of cell journey status, order fulfillment milestones, pickup, transport, delivery, and timelines with internal and external stakeholders. · Coordinate with site stakeholders, including CAR-T coordinators, apheresis teams, physicians, pharmacists, research coordinators, and vein-to-vein teams, to synchronize the patient and cell journey and support clinically appropriate slot allocation and utilization. · Assess severity and urgency of unforeseen issues related to ordering, manufacturing, rescheduling, cancellations, returns, and other exceptions; escalate and facilitate timely resolution of customer inquiries in accordance with company policies. · Act as the key liaison between internal stakeholders, including batch advocate, local release team, CAR-T Medical Director, local medical leadership, Supply Chain, and the healthcare facility in the event of an out-of-spec product. · Ensure operational performance and compliance with local and regional regulations, SOPs, data protection, advertising rules, pharmacovigilance requirements, labeling, documentation obligations, and audit or inspection readiness. Special requirements: · Field-based role with domestic travel to Canadian CAR-T treatment centres for business purposes; treatment centres may be located in different provinces and require both air and ground travel. · Occasional travel to conferences and the Toronto office may be required; overall travel may be approximately 25-50% depending on business needs. · Ability to work across Canadian time zones and provide after-hours support for treatment sites that may extend up to two hours beyond normal working hours. · Bilingual French and English is required. Other features of the job: Role features · Hybrid field-based role requiring collaboration with treatment centres, internal medical stakeholders, commercial operations, supply chain, and cross-functional partners. · Requires frequent use of order management and internal IT platforms, timely documentation, and sustained attention to operational details across the patient and cell journey. · Requires ability to manage uncertainty, urgent operational issues, challenging conversations, and timely handover or escalation with internal and external stakeholders. · Requires strong customer ex