Sumitomo Pharma
Director, Patient & HUB Operations, Rare Disease
Sumitomo Pharma, Trenton, New Jersey, us, 08628
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website and follow us on LinkedIn.
Overview
Job Overview: We are seeking a dynamic, highly motivated, and experienced individual for the position of
Director, Patient & HUB Operations, Rare Disease . The Director will lead the strategy, development, and operation of the RETHYMIC CONNECT patient support program and HUB operations supporting rare disease products. The role will design and execute program operations, systems, metrics, and HUB vendor network, and work closely with Brand Franchise, Finance, Regulatory, Legal, Supply Chain, Manufacturing, and HUB vendors. The Director will support S&OP meetings and establish cross-functional collaboration with Manufacturing and Supply Chain to ensure capacity planning, slot allocation, scheduling, and logistics. This role is integral to the development of commercial operations for SMPA rare disease assets and includes management of all patient service operations while promoting transparency, collaboration, and growth. Job Duties and Responsibilities
Oversee RETHYMIC CONNECT program operational strategy, execution, and cross-functional integration supporting rare disease product(s). Manage and lead HUB service team including patient support specialists, operations coordinators, and account liaisons ensuring delivery of high-quality services to patients, healthcare providers and network partners. Monitor and assess the performance of external patient support and logistics service partners, ensuring they perform in accordance with contracts and program requirements; implement corrective measures and monitor CAPA completion as required. Develop and maintain performance dashboards to monitor execution and drive program optimization and operational excellence. Develop program enhancements to optimize patient/caregiver experience and share brand insights with commercial leadership to refine strategy based on new insights. Develop and execute RETHYMIC CONNECT strategic imperatives and initiatives aligned with brand strategy, goals, and objectives. Lead new product launch HUB services strategy, planning, and implementation, including HUB services, educational support, treatment center/office support and onboarding, and logistics and orchestration operations. Lead development of IT system user requirements, data elements, and user interface design for CRM and orchestration ecosystem; serve as business lead for CRM and orchestration systems. Lead process mapping and development of patient journey/experience assessments on matrix teams; develop project plans, set priorities, and provide input on timing, resources, and budget projections. Support S&OP model and establish cross-functional collaboration with Finance, Supply Chain, and Manufacturing to ensure robust communication and alignment for capacity planning, slot allocation, and scheduling. Support development of a commercial capacity model and expansion of source and treatment center operations. Lead assessment and selection of distribution channel models and vendors. Monitor sales orders and facilitate distribution partner processing prior to invoicing; monitor ERP sales order operations. Negotiate and execute complex contracts/SOWs for services supporting end-to-end operations for complex therapies. Develop and maintain program materials, including call guides, SOPs, work instructions, and training resources per legal, medical, and regulatory approval processes. Support development and regulatory correspondence and serve as SME during regulatory discussions or inspections regarding HUB operations. Key Core Competencies
Detail-oriented with the ability to break down complex challenges and develop solutions and execution plans. Collaborative team-player who leads with integrity and values inclusive collaboration to achieve the best outcomes. Excellent verbal and visual communication skills; ability to communicate across all levels of an organization. Process-oriented with ability to create process maps and workflows. Project management skills including breaking initiatives into detailed steps with meaningful timelines and schedules. Strong leadership skills as both a people leader and individual contributor; ability to lead cross-functional teams and strategically partner to drive positive outcomes across a large organization. Data-driven; prioritizes data elements in process and system design. Adaptive and creative approach to problems. High degree of organizational awareness and ability to understand interdependencies and the big picture. Education and Experience
Bachelor's or master’s degree in business, scientific or related field (experience in case management a plus). Demonstrated experience developing and managing manufacturer HUB operations for cell and gene therapy products requiring complex end-to-end orchestration. Minimum of 8 years commercial or operations experience in biotech/pharmaceuticals with at least 5+ years leading HUB operating teams; experience with Cell, Gene and/or Tissue Therapies preferred. Able to build HUB and patient access services and critical systems; development and implementation of SOPs, business rules and training. In-depth knowledge of pharmaceutical manufacturer compliance, patient confidentiality, product reimbursement and product access requirements. Knowledge of regulations governing protection of patient identifying information and CMS policies pertaining to access services. Strategic business acumen and a data-driven mindset. Ability to align with brand priorities, customer needs and translate into design direction for patient support programs. Experience in reimbursement and payer pull-through. Experience implementing distribution channels and managing Sales Operations and distributor operations for cell & gene therapy products. Experience managing multiple patient service, reimbursement, and co-pay vendors. Recent rare disease product launch experience desired. Strong track record of cross-functional leadership. Proven ability to use Excel, PowerPoint and Word and the Microsoft suite. Compensation and Benefits
The base salary range for this role is $184,400 to $230,500. Base salary is part of our total rewards package which also includes merit-based salary increases, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances, and leaves in line with your work state. Our time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a year-end shutdown, and 80 hours of paid sick time upon hire and each year thereafter. Total compensation will depend on candidate experience, skills, education, and other factors permitted by law. Disclaimer: The above statements describe the general nature and level of work. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Compliance and Equal Opportunity
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital or domestic partnership status, sex, gender, sexual orientation, disability, veteran or military status, or any other characteristic protected by law.
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Job Overview: We are seeking a dynamic, highly motivated, and experienced individual for the position of
Director, Patient & HUB Operations, Rare Disease . The Director will lead the strategy, development, and operation of the RETHYMIC CONNECT patient support program and HUB operations supporting rare disease products. The role will design and execute program operations, systems, metrics, and HUB vendor network, and work closely with Brand Franchise, Finance, Regulatory, Legal, Supply Chain, Manufacturing, and HUB vendors. The Director will support S&OP meetings and establish cross-functional collaboration with Manufacturing and Supply Chain to ensure capacity planning, slot allocation, scheduling, and logistics. This role is integral to the development of commercial operations for SMPA rare disease assets and includes management of all patient service operations while promoting transparency, collaboration, and growth. Job Duties and Responsibilities
Oversee RETHYMIC CONNECT program operational strategy, execution, and cross-functional integration supporting rare disease product(s). Manage and lead HUB service team including patient support specialists, operations coordinators, and account liaisons ensuring delivery of high-quality services to patients, healthcare providers and network partners. Monitor and assess the performance of external patient support and logistics service partners, ensuring they perform in accordance with contracts and program requirements; implement corrective measures and monitor CAPA completion as required. Develop and maintain performance dashboards to monitor execution and drive program optimization and operational excellence. Develop program enhancements to optimize patient/caregiver experience and share brand insights with commercial leadership to refine strategy based on new insights. Develop and execute RETHYMIC CONNECT strategic imperatives and initiatives aligned with brand strategy, goals, and objectives. Lead new product launch HUB services strategy, planning, and implementation, including HUB services, educational support, treatment center/office support and onboarding, and logistics and orchestration operations. Lead development of IT system user requirements, data elements, and user interface design for CRM and orchestration ecosystem; serve as business lead for CRM and orchestration systems. Lead process mapping and development of patient journey/experience assessments on matrix teams; develop project plans, set priorities, and provide input on timing, resources, and budget projections. Support S&OP model and establish cross-functional collaboration with Finance, Supply Chain, and Manufacturing to ensure robust communication and alignment for capacity planning, slot allocation, and scheduling. Support development of a commercial capacity model and expansion of source and treatment center operations. Lead assessment and selection of distribution channel models and vendors. Monitor sales orders and facilitate distribution partner processing prior to invoicing; monitor ERP sales order operations. Negotiate and execute complex contracts/SOWs for services supporting end-to-end operations for complex therapies. Develop and maintain program materials, including call guides, SOPs, work instructions, and training resources per legal, medical, and regulatory approval processes. Support development and regulatory correspondence and serve as SME during regulatory discussions or inspections regarding HUB operations. Key Core Competencies
Detail-oriented with the ability to break down complex challenges and develop solutions and execution plans. Collaborative team-player who leads with integrity and values inclusive collaboration to achieve the best outcomes. Excellent verbal and visual communication skills; ability to communicate across all levels of an organization. Process-oriented with ability to create process maps and workflows. Project management skills including breaking initiatives into detailed steps with meaningful timelines and schedules. Strong leadership skills as both a people leader and individual contributor; ability to lead cross-functional teams and strategically partner to drive positive outcomes across a large organization. Data-driven; prioritizes data elements in process and system design. Adaptive and creative approach to problems. High degree of organizational awareness and ability to understand interdependencies and the big picture. Education and Experience
Bachelor's or master’s degree in business, scientific or related field (experience in case management a plus). Demonstrated experience developing and managing manufacturer HUB operations for cell and gene therapy products requiring complex end-to-end orchestration. Minimum of 8 years commercial or operations experience in biotech/pharmaceuticals with at least 5+ years leading HUB operating teams; experience with Cell, Gene and/or Tissue Therapies preferred. Able to build HUB and patient access services and critical systems; development and implementation of SOPs, business rules and training. In-depth knowledge of pharmaceutical manufacturer compliance, patient confidentiality, product reimbursement and product access requirements. Knowledge of regulations governing protection of patient identifying information and CMS policies pertaining to access services. Strategic business acumen and a data-driven mindset. Ability to align with brand priorities, customer needs and translate into design direction for patient support programs. Experience in reimbursement and payer pull-through. Experience implementing distribution channels and managing Sales Operations and distributor operations for cell & gene therapy products. Experience managing multiple patient service, reimbursement, and co-pay vendors. Recent rare disease product launch experience desired. Strong track record of cross-functional leadership. Proven ability to use Excel, PowerPoint and Word and the Microsoft suite. Compensation and Benefits
The base salary range for this role is $184,400 to $230,500. Base salary is part of our total rewards package which also includes merit-based salary increases, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances, and leaves in line with your work state. Our time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a year-end shutdown, and 80 hours of paid sick time upon hire and each year thereafter. Total compensation will depend on candidate experience, skills, education, and other factors permitted by law. Disclaimer: The above statements describe the general nature and level of work. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Compliance and Equal Opportunity
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital or domestic partnership status, sex, gender, sexual orientation, disability, veteran or military status, or any other characteristic protected by law.
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