Medical Office & Regulatory Science Strategy Director

United States, NY, New York
Regular
1/29/2024
537540

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 being to offer business & people virtual universes capable of harmonizing the product, nature and life.

Driven by an entrepreneurial spirit of more than 20,000 employees and serving nearly 310,000 companies located in nearly 140 countries, Dassault Systèmes is a European company that operates and has an impact throughout the world.

Reporting directly to the Senior Vice-President Corporate Research & Sciences, we are creating a Medical Office and a 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 will be based in Washington DC and with potential relocation in Dassault Systemes US sites. 

Your mission

Dassault Systèmes has been investing in the Life Sciences & Healthcare sector for more than 15 years extending its offer in 3 major segments: medical devices, pharmaceutical & biotech companies and medical care. The paradigm of Virtual Twin Experiences offers unprecedented opportunities for businesses transformations, cure innovation, care delivery and ultimately patient treatments.

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

As Regulatory Science Strategy Director, your mission will be to define the global strategy for the development of Dassault Systemes virtual twins for life sciences & healthcare, and to operate them in collaboration with science & 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 & pathways for twins deployment, usage, certification a/o approval for company’s selected therapeutic areas and fields of businesses (and recommendation with respect to SAMD or other equivalent regulations)
  • Provide proposal 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, to advocate the product's value to health system stakeholders, including payors, 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 taking into account political, sectoral, geographical, and technological dimensions when it comes to Medical Twins Experiences adoption and authorizations
  • Propose Dassault Systemes leadership and medical impact through existing partnerships or new approaches
  • Strengthen and expand the notoriety 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

  • Solid 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 the agencies, medical devices & pharmaceutical industries world
  • Very good technical sense, ability to analyze and synthesize
  • Excellent communication, public speaking, interpersonal relationship management and facilitation skills (C-Level interactions, 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 in network management

Diversity statement

As a game-changer in sustainable technology and innovation, Dassault Systèmes 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.

Compensation & Benefits

Dassault Systèmes 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.

Equal opportunity

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.
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Join Dassault Systèmes, The 3DEXPERIENCE Company Everything becomes possible with Dassault Systèmes’ 3DEXPERIENCE virtual universes! Serving 230,000 customers in 11 industries, from high-tech to life sciences, fashion to transportation, we help businesses and people around the world to create sustainable innovations for today and tomorrow. Get on board a leading and fast-growing company of 20,000 talented professionals.