Head of Regulatory Post-Market Research

Be a part of a revolutionary change At PMI, we’ve chosen to do something incredible. We’re totally transforming our business and building our future on one clear purpose – to deliver a smoke-free future. With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions. Our success depends on people who are committed to our purpose and have an appetite for progress. We are excited that our US headquarters in NYC has moved to Stamford, Connecticut as of November 2022. Our beautiful new location is just steps away from the Stamford Metro-North Train Station and easily accessible from NYC. The Head of Regulatory Post-Market Research has three main purposes: i) establish the strategic approach and then deploy the post-marketing research plans as requested by the FDA in the U.S. and to support regulatory efforts in the Rest of the World (RoW); ii) lead the required periodic reporting activities concerning consumers' related topics and sections to the FDA; iii) support the strategy and lead the stakeholders engagement in the U.S. with respect to pre amd post-market consumer data, in order to build societal support around PMI’s vision of a smoke-free world. Your ‘day to day’: • Define the strategy and oversight post-marketing regulatory studies, including design, execution and interpretation of results, and adopting recognized scientific standards in the U.S and the RoW, in order to fulfil regulatory requirements (e.g., U.S. FDA) and to provide data on the effect of smoke-free products on the whole population. • Lead FDA related periodic reporting activities in U.S., with respect to consumers data, in order to fulfil regulatory requirements to maintain our smoke-free products in the U.S. market. • Lead the external engagement with key stakeholders and regulators in the U.S. to support our smoke-free vision with internal and independent data on the effect of smoke-free products on intended and unintended audiences. • Oversight consumer related regulatory submissions input on the post-market sections in order to obtain the ability to commercialize smoke-free products. • Contribute to PMI’s scientific visibility, communication, and influence by developing and publishing of scientific manuscripts in recognized external journals as well as of oral or poster presentations for scientific conferences. • Lead the team in charge of post-market studies, by coordinating also coordinating interpretation and dissemination of results in order to maximize internal stakeholders' knowledge and alignment. • Ensure the coordination with the Commercial Insights function in the U.S. in order to maximize knowledge exchange and usability of post-market commercial data in the U.S. regulatory context. • Promote and direct the identification or the development of post-market standards/methods for research aimed at stakeholders and/or regulatory engagement in order to advance the quality and scientific progress, acceptance, and impact of PMI’s studies. • Directly interact with key internal stakeholders including senior managers from Regulatory Affairs, External Affairs, Scientific Engagement, Consumer Insights and U.S. Leadership Team. Who we’re looking for: • Bachelors or Advanced degree preferably in a healthcare, psychology, social, behavioral, statistics, epidemiology, research science field. • Minimum of 10 years experience applying scientific and epidemiological practices, procedures and theory related to pre and post-market studies, within a pharmaceutical, tobacco, consumer goods, clinical research or governmental agency environment. • Technical expertise in design, development and implementation of pre and post-market studies in social science, health services, epidemiology, pharmaceutical or tobacco. • Strong statistical and analytical skills. Knowledge of specialized statistical software (e.g. SPSS, SAS) will be a plus. • Confirmed leadership skills, results-oriented, ability to work in a collaborative set-up, stakeholder and team management . Sound oral and written communications skills, ability to summarize and disseminate analyses. Fluent in English, both written and spoken. • Authorized to work in the US. Annual Base Salary Range: $188,000-$258,500 What we offer • We offer a competitive base salary, annual bonus (applicable based on level of position), great medical, dental and vision coverage, 401k with a generous company match, incredible wellness benefits, commuter benefits, pet insurance, generous PTO, and much more! • We have implemented Smart Work, a hybrid model of working that promotes flexibility in the workplace. • Seize the freedom to define your future and ours. We’ll empower you to take risks, experiment and explore. • Be part of an inclusive, diverse culture where everyone’s contribution is respected; Collaborate with some of the world’s best people and feel like you belong. • Pursue your ambitions and develop your skills with a global business – our staggering size and scale provides endless opportunities to progress. • Take pride in delivering our promise to society: To improve the lives of a billion smokers. #LI-Hybrid PMI is an Equal Opportunity Employer PMI Global Services Inc. and PM Global Brands Inc. are a subsidiary of Philip Morris International Inc. Philip Morris International (PMI) is leading a transformation in the tobacco industry to create a smoke-free future and ultimately replace cigarettes with smoke-free products to the benefit of adults who would otherwise continue to smoke, society, the company, its shareholders and its other stakeholders. PMI is a leading international tobacco company engaged in the manufacture and sale of cigarettes, as well as smoke-free products, associated electronic devices and accessories, and other nicotine-containing products in markets outside the U.S. In addition, PMI ships versions of its IQOS Platform 1 device and consumables to Altria Group, Inc. for sale under license in the U.S., where these products have received marketing authorizations from the U.S. Food and Drug Administration (FDA) under the premarket tobacco product application (PMTA) pathway; the FDA has also authorized the marketing of a version of IQOS and its consumables as a Modified Risk Tobacco Product (MRTP), finding that an exposure modification order for these products is appropriate to promote the public health. PMI is building a future on a new category of smoke-free products that, while not risk-free, are a much better choice than continuing to smoke. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, PMI aims to ensure that its smoke-free products meet adult consumer preferences and rigorous regulatory requirements. PMI's smoke-free product portfolio includes heat-not-burn and nicotine-containing vapor products. As of September 30, 2022, PMI's smoke-free products are available for sale in 70 markets in key cities or nationwide, and PMI estimates that approximately 13.5 million adults around the world, excluding Russia and Ukraine have already switched to IQOS and stopped smoking. For more information, please visit www.pmi.com and www.pmiscience.com.