Patient Operations Lead for Cell & Gene Therapy Industrialization
Genentech
Kaiseraugst, Switzerland
vor 3 Tg.
source : Experteer

Purpose Roche Pharma Global Technical Operations (PT) desires to develop an Industrialization Concept for future Cell & Gene Therapy (CGT) Products.

Along with this new class of CGT products, new innovative cell and genetic engineering technologies are introduced into PT, framed by new quality standards and regulations.

Efforts are ongoing to build capabilities that serve as enablers to success with new molecular modalities (reprogrammed cells, neo-epitope targeted therapies, viral vector based gene therapy etc.

where supply to patients needs to be swift, reliable, and sometimes fully individualized. In this context, Roche has identified Patient Operations that is focused on managing the interface of manufacturing and supply with specialty pharmacies / treatment centers, patients and care caseworkers, as a core enabling capability for the successful management of the development and commercialization of Cell and Gene Therapy products.

The Patient Operations Lead for Cell & Gene Therapy Industrialization will develop the patient operations function in Pharma Technical in close collaboration with partners in the commercial organization (RD recognition partners, local and global access teams, medical affairs), and clinical operations.

Initially, the Patient Operations Lead will create and lead a workstream that is part of the CGT Industrialization program to charter the team and define the scope and interfaces of the Patient Operations group, develop the project and implementation plan for the Patient Operations platform, and manage communication across stakeholders to ensure good integration of patient operations with program teams.

Additionally, the Patient Operations Lead will determine the structure of an organization responsible for performing the patient operations function going forward, including the size of the organization, the scope of the duties and responsibilities, and the capabilities required.

This position has a high potential to be the leader of the future function.Key Responsibilities / TasksAnalyze current as-is capabilities Assess existing ordering and supply processes, order-to-cash concepts and processes, and inventory / evaluate the efforts on-going to supply direct-to-patient products.

Assess the options and potential of existing efforts to address requirements for follow-up of patients and potential Pay for Performance reimbursement models Understand the unique requirements / needs for make-to-order (made for a single patient) and off-the-shelf (made for multiple patients) Cell and Gene Therapy products and the service level options to manage the interface between supply and receipt of product for patient administration that will create value by supporting and securing end-to-end security of supply (CoI / CoC where applicable) and reduce patient uncertainty.

Identify connections to existing efforts / teams / workstreams needed to appropriately design patient operations to eliminate redundant and unnecessary hand-overs, incorporate the needs of the patient / pharmacy / treatment center for order visibility and reduced uncertainty, and to support the design and implementation of an orchestration concept currently under developmentFacilitate sprints and pilots with cross-functional teams and stakeholders to define the needs that drive valueUnderstanding of capability gaps Survey the field of Cell and Gene Therapy and rare disease treatments to collect insights from the external landscape about patient operationsExplore the emerging interface needs with treatment centers, pharmacies and pathology labs, as well as other non-traditional value chain members relevant to Cell and Gene Therapy products.

Understand the dynamics of the interface between facility accreditation and GMP controls with a view to simplification / standardization of the interactions that would improve the connections at these steps .

Gain insight and create value through development of value creating operations which facilitate a seamless transition across business processes and provide robust and transparent patient-centric supply solutions to the expanded value chain for Cell and Gene Therapy products Connect with other workstreams and teams to collect and define input, needs, and interface requirements both for patient ops and from patient ops for other work streams, e.

g. orchestration and logistics, so that PT s systems and processes are appropriately designed at the treatment center / pharmacy / tissue lab interfaceDeliver an operational concept and design for patient operations, develop the team, charter, road map, project plan and the associated budgetIdentify and appoint team members from a broad range of disciplines and backgrounds to co-create the Patient Operations capabilityInvolve stakeholders from the wider organization in the design and development of the platform capability for Patient Operations with a consideration for where differences in applicability are warranted between Make-to-Order therapies and Make-to-Stock therapies.

Clarify the linkages between traditional manufacturing and supply functions (manufacturing, quality, supply, order-to-cash) and other stakeholder groups involved in medical care and support of the patients such as RD recognition partners, local and global access teams, and medical affairs, to ensure a sustainable and comprehensive delivery that creates value for patients by providing predictable and tailored product supply, support and accessConvey a passion for developing simple solutions that keep the patient in focusDevelop and deliver a proposed operation and the organizational set-up needed to support the successful operation.

Build and maintain strong linkage between Patient Ops, Orchestration, and Data Informatics workstreams to provide seamless operations across these platform capabilities.

Education and ExperienceBachelors or advanced degree in science or business administration10+ years working experience in pharma, specialty pharmacy or patient care with a focus on supply chain, medical case management or patient access / reimbursementExperienced individual who has worked for a pharmaceutical company on a global scale.

Proven track record of translating complex problems into innovative solutions and transforming organizational mindset and capability to capture value through optimizing the patient experience.

Experienced individual in global project management (Agile Project Management incl Team Sprints, Scrum) Experience leading matrixed teams of senior experts to deliver creative solutions for complex problems Knowledge / Skills / CompetenciesCreative problem solving skills fueled by a high level of curiosity Excellent leadership skills and experience leading matrixed teamsHighly collaborative and able to influence, understand and align with stakeholders at all levels across the organizationAnalytical strengthExcellent communication skills with the ability to engage stakeholders with diverse backgroundsAbility to think out of the box and bring in innovative conceptsAbility to interact with senior leaders, build relationshipsAble to add value immediatelyAbility to travel internationally as required by business needs (up to25%)?Full time

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