Role and Responsibilities

Dassault Systemes, "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 Systemes 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 Systemes office in the United States - San Diego, New York, Seattle...

Your mission

Dassault Systemes 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 Systemes' 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 Systemes' leadership and medical impact through existing partnerships or new approaches
• Strengthen and expand the reputation and medical image of Dassault Systemes as well as its representation among medical communities
• Represent Dassault Systemes 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.)

Qualifications

• Proven professional experience of at least 10 years, part of which is in the development and management of medical innovation, regulatory science, networks and communities
• Experience leading large-scale projects and working with multidisciplinary teams, based in different regions around the world
• Knowledge of Regulatory agencies, medical devices and pharmaceutical industries worldwide
• Experience working, developing or supervising projects in the technology space related to SaMD
• Ability to analyze, summarize and simplify complex information to present it in a way that is easy to understand and to help make strategic decisions
• Excellent communication, public speaking, interpersonal relationship management and facilitation skills (interacting with C-Level executives internationally)
• Ability to understand and work in a matrix environment, both corporate, functional and geographical - ability to work transversally with other organizations within Dassault Systemes
• Experience in a large group/international level research organization

As a game-changer in sustainable technology and innovation, Dassault Systemes is striving to build more inclusive and diverse teams across the globe. We believe that our people are our number one asset and we want all employees to feel empowered to bring their whole selves to work every day. It is our goal that our people feel a sense of pride and a passion for belonging. As a company leading change, it's our responsibility to foster opportunities for all people to participate in a harmonized Workforce of the Future.

Dassault Systemes offers an excellent salary with potential for bonus, commensurate with experience. Benefits include a choice of plans providing comprehensive coverage for medical, dental, vision care for employee & dependents as well as employee life, short & long term disability, tuition reimbursement, immediate 401K enrollment, 401K match (50 cents on the dollar, up to the first 8% of your eligible compensation that you contribute based on match eligibility criteria), flexible time off policy, and 10 paid holidays.

In order to provide equal employment and advancement opportunities to all individuals, employment decisions at 3DS are based on merit, qualifications and abilities. 3DS is committed to a policy of non-discrimination and equal opportunity for all employees and qualified applicants without regard to race, color, religion, gender, sex (including pregnancy, childbirth or medical or common conditions related to pregnancy or childbirth), sexual orientation, gender identity, gender expression, marital status, familial status, national origin, ancestry, age (40 and above), disability, veteran status, military service, application for military service, genetic information, receipt of free medical care, or any other characteristic protected under applicable law. 3DS will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.