Sumitomo Pharma
Director, Patient & HUB Operations, Rare Disease
Sumitomo Pharma, Denver, Colorado, United States, 80285
Overview
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\u2019s 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 https://www.us.sumitomo-pharma.com and follow us on LinkedIn.
Job Overview
We are currently 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 the rare disease product(s). The Director leads the design and execution of program operations, systems, metrics, and HUB vendor network. The role involves collaboration with key stakeholders including the Brand Franchise team, Finance, Regulatory, Legal, Supply Chain, and Manufacturing, as well as critical HUB vendors. The Director will support S&OP meetings and establish a cross-functional collaboration model with Manufacturing and Supply Chain to ensure robust communication and alignment for capacity planning, slot allocation, scheduling, and logistics. This role plays an integral part in the development of commercial operations for SMPA rare disease assets and manages all patient service operations while fostering 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 to ensure high-quality services to patients, healthcare providers and network partners. Monitor and assess the performance of external patient support and logistics service partners; ensure adherence to contracts and program requirements; implement corrective measures and CAPAs 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 relevant brand insights with commercial leadership to refine strategy and execution based on new insights. Develop and execute RETHYMIC CONNECT program 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; 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 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 invoice; monitor ERP sales order operations. Negotiate and execute complex contracts/SOWs for services supporting end-to-end operations for complex therapies. Develop and maintain all program materials, including call guides, SOPs, work instructions and training resources per SMPA legal, medical, and regulatory approval process. Support development and regulatory correspondence and act 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 the ability to create process maps and flows. Project management skills including the ability to break down initiatives into detailed steps with timelines and schedules. Strong leadership skills as both a people leader and individual contributor; ability to lead cross-functional teams and partner to drive positive outcomes. Data-oriented; 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\u2019s or master\u2019s 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 and laws 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/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 general Microsoft suite software. 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, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. 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 for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, gender, sexual orientation, disability, veteran or military status, or any other characteristic protected by law. Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S., Canada and Europe focused on oncology, urology, women\u2019s health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products and a diverse pipeline, we aim to accelerate discovery and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com and follow us on LinkedIn.
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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\u2019s 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 https://www.us.sumitomo-pharma.com and follow us on LinkedIn.
Job Overview
We are currently 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 the rare disease product(s). The Director leads the design and execution of program operations, systems, metrics, and HUB vendor network. The role involves collaboration with key stakeholders including the Brand Franchise team, Finance, Regulatory, Legal, Supply Chain, and Manufacturing, as well as critical HUB vendors. The Director will support S&OP meetings and establish a cross-functional collaboration model with Manufacturing and Supply Chain to ensure robust communication and alignment for capacity planning, slot allocation, scheduling, and logistics. This role plays an integral part in the development of commercial operations for SMPA rare disease assets and manages all patient service operations while fostering 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 to ensure high-quality services to patients, healthcare providers and network partners. Monitor and assess the performance of external patient support and logistics service partners; ensure adherence to contracts and program requirements; implement corrective measures and CAPAs 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 relevant brand insights with commercial leadership to refine strategy and execution based on new insights. Develop and execute RETHYMIC CONNECT program 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; 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 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 invoice; monitor ERP sales order operations. Negotiate and execute complex contracts/SOWs for services supporting end-to-end operations for complex therapies. Develop and maintain all program materials, including call guides, SOPs, work instructions and training resources per SMPA legal, medical, and regulatory approval process. Support development and regulatory correspondence and act 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 the ability to create process maps and flows. Project management skills including the ability to break down initiatives into detailed steps with timelines and schedules. Strong leadership skills as both a people leader and individual contributor; ability to lead cross-functional teams and partner to drive positive outcomes. Data-oriented; 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\u2019s or master\u2019s 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 and laws 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/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 general Microsoft suite software. 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, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. 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 for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, gender, sexual orientation, disability, veteran or military status, or any other characteristic protected by law. Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S., Canada and Europe focused on oncology, urology, women\u2019s health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products and a diverse pipeline, we aim to accelerate discovery and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com and follow us on LinkedIn.
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