Medical Office & Regulatory Science Strategy Director

Role and Responsibilities

Dassault Systèmes, "The 3DEXPERIENCE Company", is a scientific company that addresses innovation challenges in three strategic sectors of the economy: Manufacturing Industries, Infrastructure and Cities, as well as Life Sciences and Healthcare. The purpose of the company is to offer business & people virtual universes capable of harmonizing the product, nature and life.

Driven by an entrepreneurial spirit of more than 24,000 employees and serving nearly 310,000 companies located in nearly 140 countries, Dassault Systèmes is a European based company that operates and has an impact throughout the world.

Reporting directly to the Senior Vice-President Corporate Research and Sciences, we are creating a Medical Office position for Regulatory Science Strategy Director to define, implement and execute a new strategy related to healthcare affairs with respect to regulatory, clinical development and market access domains.

This position is based in any Dassault Systèmes office in the United States – San Diego, New York, Seattle...

Your mission

Dassault Systèmes has been investing in the Life Sciences and Healthcare sector for more than 15 years extending its offer in three major segments: medical devices, pharmaceutical and biotech companies and medical care. The paradigm of Virtual Twin Experiences offers unprecedented opportunities for business transformations, innovation in treatment, care delivery, and ultimately patient outcomes.

With science as our core DNA, we are convinced that Virtual Twin Experiences embody a new and disruptive approach for life sciences industries, practitioners, regulators and payers, benefitting the health of individuals. As Virtual Twin Experiences enter the healthcare domain, new practices will emerge that will require new frameworks, guidelines, value creation pipelines, certifications, standardizations and access. These will affect all stakeholders, from medical devices manufacturers to new therapeutics manufacturers to healthcare providers.

As our Regulatory Science Strategy Director, your mission will be to define the global strategy for the development of Dassault Systèmes’ virtual twins for life sciences and healthcare and to operate them in collaboration with science and business organizations.

Your future challenges

• Formulate and frame a global approach for virtual twins for medical practices as well as self-care.
• Define and develop strategies, positioning and pathways for twin’s deployment, usage, certification and/or approval for our selected therapeutic areas and fields of businesses (and recommendation with respect to SaMD or other equivalent regulations)
• Provide proposals for clinical development frameworks, for designing study protocols and overseeing their execution of candidate twin solutions
• Propose and execute a strategy for Medical Twin Experiences market access assessment, advocating the product's value to health system stakeholders, including payers, nations and hospitals.
• Propose and execute a strategy for regulatory affairs conduct, spearheading the assessment of twin experiences quality, benefits and associated risks throughout their development, deployment and maintenance in both clinical and real-world/post-market settings.
• Ensure the relevance of alliances considering political, sectoral, geographical, and technological dimensions concerning Medical Twins Experiences adoption and authorizations
• Propose Dassault Systèmes’ leadership and medical impact through existing partnerships or new approaches
• Strengthen and expand the reputation and medical image of Dassault Systèmes as well as its representation among medical communities
• Represent Dassault Systèmes in public/private alliances at the intersection of academic and industrial medical hubs, in conjunction with different stakeholders (key clients, industries, universities, leading laboratories, agencies, etc.)

The total expected compensation range for this role is between $225,000 - $280 000. In determining the pay range, we take into consideration experience, pay of employees in similar positions, and other job-related factors.