Cell & Gene Therapy Digital Value Chain Delivery Lead

The Position

Roche Pharma Global Technical Operations (PT) delivers a fast evolving portfolio of new Cell & Gene Therapy (CGT) products to bring new curative treatments to patients. This portfolio of new products comes with the great promise to bring unprecedented medical advances to patients but also presents unique challenges: living products (e.g. cells) need to be delivered to patients in highly personalized supply chain models, which meet fast turn-around-times at a zero-error quality level.

Efforts are ongoing to build CGT capabilities that serve as enablers to success with new molecular modalities (reprogrammed cells, neo-epitope targeted therapies, viral vector based gene therapy etc.). These new CGT capabilities are designed within the context of new, patient centric value chains that facilitate a seamless transition of products, a safe exchange of personalized health data and enables a successful patient journey.

As the CGT Digital Value Chain Delivery Lead you will be responsible to build new patient-centric CGT value chains, foster cross-functional collaboration in developing new capabilities and drive the implementation within time and budget. This includes the design and build of a new digital infrastructure through a program of digital value chain delivery projects.

A successful new digital infrastructure for CGT needs to enable direct order management and product supply between PT and Treatment Centers in a fast and safe manner so that chain of custody and identity is maintained. At the same time new digital capabilities need to be integrated into the new ERP architecture in PT which is rolled out as part of the Aspire program.

Your role as CGT Digital Value Chain Delivery Lead will be to integrate the different digital value chain delivery projects in CGT into an End-To-End program in close collaboration with the broader PT digital transformation.

You will bring your many skills to the table including senior leadership, strategic thinking, program management, and stakeholder management and agile project management delivery.

Your key responsibilities

Your general accountability is defined by the Roche corporate directives, guidelines and operating principles, as well as by the company’s core values and behaviors (please refer to www.roche.com for more details). In the particular role you will have the following major responsibilities:

Regarding Project leadership you will:

• Lead design and implementation efforts to deliver the End-to-End Value Chain Digital Infrastructure for Cell & Gene Therapies (ITCT & GT) in collaboration with value chain design leads, CGT chapters and functions (eg Product Owner, SMEs) . This will include owning the E2E readiness and governance, creation of technology-enabled, streamlined processes and technology configuration trade-off choices.
• Develop comprehensive strategies and integrated E2E plans, as well as, monitor and direct the implementation of value chain delivery projects. CGT presents a highly innovative CMC portfolio with highly volatile CMC timelines which needs to be reflected in a corresponding project plan which independently and proactively adapts to changing requirements.
• Responsible for achieving the project goal as a contribution to higher level division goals, solves problems and makes decisions independently. Proactively coordinates within cross-functional interfaces with relevant stakeholders, including, preparation of information, project status updates, alignment, conflict resolution and development of recommendation and proposals.
• Secure the internal and external talent required to mobilize and execute the portfolio of initiatives. Decide on final team composition and assembly of sub-team structures.

As a strategic partner, you will:

• Co-lead the internal and external facing steering teams for E2E Value Chain Digital Projects together with the responsible IT Program Manager and represent the “voice of the business” in external vendor negotiations
• Partner with CGT chapter and/or capability leads to create technology-enabled products & services which includes management of cross-product owner/ cross platform design topics, leading the work to realize our strategies.
• Act as the Value Chain delivery liaison for selected product teams (eg TDT, TPT, etc..) which rely on the successful build of a digital infrastructure to launch clinical and commercial CGT products.

Who You Are

We have high expectations around end-to-end thinking and cross functional collaboration in a global network by taking ownership and delegating decisions to the appropriate level. We value an entrepreneurial mindset with the ability to constantly change or adapt in a dynamic environment. We expect you to focus on the most impactful and value adding work by prioritizing your efforts with a clear focus on creating value for the patient. You will be willing to explore new opportunities, be comfortable with ambiguity and taking smart risks, while complying with the latest regulations. In addition you bring:

• A profound history of prior business experience with increasing responsibilities in the biotechnology, pharmaceutical arena, and CGT therapies, is required
• Background and experience in value chain management and digital implementations of CGT therapies
• Deep experience in designing and implementing CGT patient-centric value chain, including building of new digital infrastructure and integration with legacy infrastructure
• At least 10 years program management experience, with exposure to the design and administration of business strategy development and execution
• Experience of leading large cross functional agile programs with a substantial validated enabling technology element in a highly regulated industry, with agile methodologies (e.g. SAFe, SCRUM, KANBAN)
• Knowledge of regulations and guidelines related to CGT pharma compliance of computerized systems (relevant elements of ATMP regulations, GxP, GxP for ATMPs, relevant CFR) and data (GDPR, HIPAA, local regulations)

Position requires up to 25% international travel.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.