About Oncode Accelerator Foundation

The Oncode Accelerator Foundation is a non-profit organization, founded in 2022 to coordinate the central activities in the Oncode Accelerator-program and to act as the coordinator for the program.

The Oncode Accelerator Foundation is located in Utrecht and consists of a highly motivated group of professionals including program managers, business developers and project managers who support the Oncode Accelerator program together with the financial team and the communication team. It is a fastmoving, dynamic organization with an open and transparent culture that will grow considerably in the coming years.

Oncode Accelerator innovates the preclinical development process by harnessing the power of three innovation platforms: Well-Defined Patient Cohorts, Organoid Models and Artificial Intelligence. This will enable better prediction of the safety and efficacy of new therapies for specific patient populations. To ensure that these innovative methodologies are adopted and implemented for the validation of new therapies, the Oncode Accelerator program has established a Regulatory Innovation workstream to align the Program’s activities closely with regulatory authorities. The Regulatory Innovation workstream will conduct regulatory studies on the Oncode Accelerator innovation platforms, assess their impact and readiness, and establish interactive tools for the dissemination of regulatory information. To ensure the acceptability of the pipeline and the innovations, the workstream will be in continuous interaction and collaboration with regulatory authorities such as the European Medicines Agency and the Dutch Medicines Evaluation Board, through joint workshops and trainings, as well as through formal interactions. To support these activities, the Oncode Accelerator Foundation is looking for a Program Manager Regulatory Innovation.

Candidate

A successful Regulatory Innovation Programme Manager will interact with and manoeuvre between different parties and work with the Oncode Accelerator network to create and maintain the conditions necessary to achieve the objectives and deliverables of the Regulatory Innovation workstream. The professional will help to establish a structure for ongoing regulatory dialogue, training and interaction with regulators and other downstream organisations throughout the duration of the program. In addition to knowledge of regulatory sciences, the position requires a broad understanding of preclinical drug discovery and development, (pre-) clinical development strategies and the current landscape of pharmaceutical clinical trials and marketed drugs, preferably within the field of Oncology.

Main duties and responsibilities:

• Preparing and coordinating multi-stakeholder expert meetings on regulatory innovation including briefing and debriefing partners, recruiting experts for stakeholder meetings, ensuring quality and consistency on regulatory innovation activities throughout the Oncode Accelerator program.
• Monitor the progress of all regulatory innovation activities against timelines and available budget and provide ideas to increase the efficiency of monitoring and reporting.
• Act as liaison with various internal and external partners to ensure their continued engagement and to develop the strategy for regulatory acceptance of the novel methodologies.
• Ensure high quality of all activities and deliverables by liaising with program managers, communications, finance, business development colleagues and external content experts to ensure the project meets its objectives
• Take ownership of assigned tasks and processes and provide ideas to improve efficiency, cohesiveness and effectiveness.
• Organize activities in accordance with the mission and goals of the organization.

• 3+ years of professional experience (or a PhD) in a relevant field, preferably in regulatory science, medical technology or health policy.
• Familiarity with preclinical drug discovery & development and pharmaceutical clinical trials.
• Knowledge of regulatory policies and procedures for obtaining marketing authorization
• Preferably, but not necessarily, a good understanding of the Dutch healthcare system, for example through one or more years professional experience in a relevant organization
• Excellent organizational, planning and execution skills, preferably with experience of using project management tools
• Structured, results-oriented, punctual with a desire to excel in operational quality
• Strong work ethic with the ability to work both independently and as part of a team
• Proactive and flexible, not afraid to “jump in” when needed
• Excellent interpersonal communication skills; fluent in both Dutch and English

What will you get in return?

• Being member of an agile, diverse and international team of professionals
• Being part of a large community of oncology R&D professionals from academia, academic medical centers and biotech/pharma companies
• Building an international network of regulatory professionals
• Opportunity to make a positive impact in the field of oncology drug development 
• Competitive remuneration package including a gross montlhy salary of € 5.000 - € 7.000 based on a full-time employment

Oncode Accelerator is a national growth fund program that aims to innovate the preclinical development process for cancer therapy so that drugs are developed faster with a higher chance of success. We do this by putting the patient at the center of the development process by making use of patient data, patient-specific models and artificial intelligence. It is Oncode Accelerator’s mission to outsmart cancer and impact lives.