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, Patient & HUB Operations, Rare Disease will lead the strategy, development, and operation of the RETHYMIC CONNECT® patient support program & 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 Director will work closely 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 the 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. This role also manages all patient service operations while supporting a culture of 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 agreed upon contracts and program requirements; implement corrective measures and monitor completion of CAPAs as required.
• Develop and maintain performance dashboards to monitor execution and drive program optimization and operational excellence.
• Develop program enhancements that will optimize patient/caregiver experience and share relevant brand insights and updates with commercial leadership to refine the program strategy and execution based upon 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 but not limited to HUB services, educational support, treatment center/office support & onboarding, and logistics and orchestration operations.
• Lead development of IT system user requirements, data elements, and user interface design for CRM and orchestration ecosystem supporting complex end-to-end product operations. Serves as business lead for CRM and orchestration systems.
• Lead process mapping and development of patient journey/experience assessments on matrix teams for complex projects, develop of project plans, set project priorities, and provide input on timing, resources, and budget projections
• Support S&OP model and establish cross-functional collaboration with the Finance, Supply Chain, and Manufacturing units 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 invoice. Monitor ERP sales order operations.
• Negotiate and execute complex contracts/SOWs for desired services supporting the end-to-end operations for complex therapies.
• Develop and maintain all program materials, including call guides, SOPs, work instructions and training resources per the SMPA legal, medical, and regulatory approval process
• 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 recognizes the value of inclusive collaboration to achieve the best outcomes.
• Excellent verbal and visual communication skills; ability to communicate across all levels of an organization.
• Process-oriented, ability to create process maps and flows.
• Project management skills including the ability to break down initiatives into detailed steps with meaningful timelines and schedules.
• Strong leadership skills as both a people leader and individual contributor; able to lead cross-functional teams and strategically partner to drive positive outcomes across a large organization.
• Data-oriented; prioritizes data elements in process and system design
• Adaptable and creative approach to problems
• High degree of organizational awareness, ability to connect the dots to understand all the interdependency and 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 and laws governing the 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

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 the opportunity for 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.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

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, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.