CART Scientific Operations Lead

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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 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 experience orientation and ability to adapt communication style channel and cadence to treatment centre preferences.

Key working relationships:

Internal

Strong collaboration with Medical Affairs CAR-T Medical Director Cell Therapy Strategic Lead Medical Education Marketing Access Communications Regulatory Affairs Pharmacovigilance Quality Commercial Operations Supply Chain local release team batch advocate and other internal business partners to execute scientific strategy evidence generation clinical trial initiatives and operational priorities.

External

Trusted peer-to-peer relationships with KOLs external experts CAR-T treatment centres and site stakeholders including CAR-T coordinators apheresis teams physicians pharmacists research coordinators and healthcare facility operations teams.

Responsive scientific educational medical and operational support to enable evidence generation site readiness order fulfillment and a positive cell therapy customer experience.

Job location:

Field-based role located in Canada with travel to Canadian CAR-T treatment centres and regular presence in the Toronto office as required.

Essential knowledge and skills:

Terminal Degree in natural sciences is required (MD PhD PharmD) with advanced scientific or clinical training in cellular therapy strongly preferred.

Minimum 3 years of relevant experience in a customer-facing role ideally in a hospital patient care coordination local study management pharmaceutical industry or role working directly with hospitals and multiple internal stakeholders.

Minimum 2 years of prior Medical Science Liaison (MSL) experience is required with demonstrated capabilities in scientific communication external expert engagement and development of trusted KOL relationships.

Demonstrated experience contributing to medical strategy evidence generation clinical trial initiatives protocol development scientific material review advisory boards workshops publications and cross-functional medical projects.

Experience with hospital logistics and operations hospital systems order management platforms customer experience and project management.

Strong understanding of CAR-T biology the end-to-end manufacturing process patient services supply chain processes logistics and order fulfillment requirements.

Previous clinical experience as a CAR-T coordinator experience in a transplant department cell therapy experience supply chain experience is an asset.

Fluency in French and English is required; ability to communicate effectively with healthcare facilities and internal stakeholders across Canada.

Solutions- and detail-oriented mindset with strong planning organizational presentation facilitation and project management skills.

Ability to manage multiple priorities operational ambiguity urgent escalations and challenging conversations while maintaining customer focus and compliance.

Good knowledge of GCP SOPs pharmacovigilance data protection advertising rules documentation standards and audit or inspection of readiness expectations.

Demonstrated leadership behaviours and ability to work effectively in a matrix environment with medical commercial supply chain quality regulatory and treatment site partners.

Core competencies required for this role:

Scientific acumen and strategic mindset

Proactive stakeholder engagement

Operational excellence

Cross functional leadership

Insight generation

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request accommodation please contact us via or contact AskGS to be directed to your accommodation resource.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment as well as get a parents consent for the background check.

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