Enable America Jobs

Cell Therapy Operations Lead - 2406171034W

Description

Janssen Inc., a Johnson & Johnson company, is recruiting for a Cell Therapy Operations Lead, located in Toronto, Canada.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Inc., is part of the Janssen Pharmaceutical Companies. Please visit www.janssen.com/canada/ for more information.

The CTOL is the primary point of contact for CAR-T treatment centres for all matters related to the provision of JJIM CAR-T products. CTOL provides the connection between commercial operations and medical matters as a member of the local CAR-T medical team. Its field-related activities include:

• Managing end-to-end site set-up & certification activities and site lifecycle maintenance requirements to ensure site and staff readiness to successfully manage cell therapy orders; Updating training material in accordance with Health Canada requirements;

• Delivering and supporting the coordination of up-front and ongoing education and training of sites for systems, protocol, and policies that support order fulfillment based on site readiness (e.g., modify training requirements for existing clinical sites); including in-person order and technology utilization support with accompanying educational materials;

• Informing and supporting order tracking and operations coordination post-order placement and communicates cell journey status with the appropriate internal and external stakeholders; supporting the end-to-end JJIM CAR-T utilization experience for sites; identifying process improvement opportunities based on customer feedback on order journey, policies and procedures;

• Ensures operational performance and compliance with obligations, understands key supply chain processes such as planning, delivery and activation, and confirms labeling and documentation obligations. Coordinates apheresis nurses, CAR-T coordinators, research coordinators and vein-to-vein team to communicate site requirements regarding production, space availability, ensures the right information and support is provided for adverse event reporting, and tracking; Managing site performance data and activity (including slot allocation and utilization), and customer feedback data and funnel up to larger team;

• Assess severity and urgency of unforeseen issues related to the ordering and manufacturing of the CAR-T product; manage issue resolution for orders in a timely manner (e.g., rescheduling, cancellations, returns, and all other exceptions); escalate and facilitate timely closure for all customer inquiries; assisting the communication between various internal and external stakeholders in the event of an out-of-spec product; supporting the treatment centre in administering the OOS product through either clinical trial or Open Label Individual Protocol;

• Stay up-to-date with technical, medical, and compliance-related training on CAR-T and the CAR-T related therapeutic area(s).

• Act in full compliance with relevant local and regional regulations and SOPs, in particular: Data Protection, Advertising Rules, Corporate SOPs, PV; ready to support any audit or inspection by local health authorities.

• Acting as the key person liaison person between the various internal stakeholders (e.g. batch advocate, local medical director, local release team) in the event of an out-of-spec product.

• Working across different Canadian time zones; ready to provide after-hour support for treatment sites that can extend 2 hours beyond the normal working hours.

The CTOL is a local role dedicated to CAR-T, helping to deliver a best-in-class customer experience through the CAR-T process. Provides training to the healthcare facility during the qualification process.

Acting as the primary contact for the healthcare facility on all matters related to the provision of JJIM CAR-T product(s). Assisting treatment centers with case management, supporting treatment site onboarding on the order management IT platform, and ensuring the right stakeholders receive the right information. Works with site stakeholders, especially the CAR-T coordinator, apheresis team, physician, and pharmacist to coordinate all CAR-T-related operations. Hosts regular meetings with qualified healthcare facilities on available manufacturing slots to ensure clinically appropriate allocation and maximal utilization.

Supports patient intake by verifying the completeness of the information, as well as the process of ordering, cell processing, cell transport, and delivery. Collaborates with internal stakeholders to resolve issues with ordering or manufacturing in accordance with company policies. Supports rescheduling and cancellations as needed, proactively communicates with treatment centers, uses the IT platform, and responds to their requests.

Enables synchronization of patient and cell journey, proactively checks and facilitates order fulfillment by collaborating with JJIM stakeholders, coordinates cell pickup and delivery based on location preferences in collaboration with the Supply Chain department. Communicates regularly about cell status location and timelines.

Acts as the primary liaison person between the various internal stakeholders (e.g. batch advocate, local release team, CAR-T medical director) and the healthcare facility in the event of an out-of-spec product. Ensures appropriate information is communicated and uploaded to the various internal systems in a timely manner. Escalates to the appropriate stakeholders if experiencing delays.

Provides a positive customer experience, understands customer preferences, and adapts to ways of working, such as the type and frequency of communication (e.g., in person, by phone, or email). Collects and communicates issues and queries from customers, coordinates the search and resolution of issues related to day-to-day site operations, IT platform, patient journey, or other factors. Acts as a point of contact for any logistical or operational issues of the site, contributing additional resources until the issue is resolved. Identifies process improvement opportunities based on customer feedback on order journey, policies and procedures.

CTOL will require an extensive skillset, including knowledge of the product and the entire CAR-T manufacturing process, abilities to handle uncertainties, challenging conversations with internal and external stakeholders (including our customers), excellent insight and relationships with cross-functional partners to allow timely and appropriate handover and escalation, and the individual would also require to have a basic understanding of supply chain, logistics and potentially PO management. Stay up-to-date with technical, medical, and compliance-related training on CAR-T and their related therapeutic area. Supports Cell Therapy Strategic Lead and CAR-T Medical Director in the healthcare facility qualification process by providing medical and clinical expertise on matters related to the delivery of CAR-T therapy locally.

Qualifications

Required Minimum Education:

• Degree natural sciences (Bachelor's or Master's)

Required Years of Related Experience:

• 3 years of experience in a customer-facing role, ideally in a hospital (e.g., coordinating patient care) or working with hospitals (e.g., customer service or local study management), experience working with multiple internal stakeholders

• Fluency in English

• Experience with hospital logistics/operations, hospital systems, order management platforms, and in customer experience and project management

Deep understanding of available patient services

• Solutions- and detail-oriented mindset

Travel on the Job: Yes

• Domestic travel to Canadian CAR-T treatment centres for business purposes up to two days a week on average. These treatment centres may be located in different provinces and both air and ground travel maybe required. Travel 1-2 days per week to office in Toronto.

Percentage Traveled: 50%

Preferred Area of Study:

Nursing, malignancy hematology, cellular therapy

Preferred Related Industry Experience:

Previous clinical experience as a CAR-T coordinator in a hospital

Previous pharmaceutical industry experience in a similar role:

Experience in a transplant department, cell therapy experience, or supply chain experience is an advantage

Preferred Knowledge, Skills and Abilities:

• Fluency in French is an asset

• Experience as a Nurse Manager is an asset

• Experience with quality of experience and business quality is preferred.

Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

ERADICATECANCER

Primary Location NA-CA-Ontario-Toronto

Organization Janssen Inc. (7710)

Job Function Medical Affairs & Marketed Products

Req ID: 2406171034W