Senior Clinical Scientist – Neuchatel, Switzerland 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 smoke-free products with the power to improve the lives of a billion smokers worldwide. 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. It’s so rare in R&D that everything aligns to create the ideal conditions for outstanding work. Right now, at PMI, that’s exactly what’s happening. R&D is the driving force for our bold new vision: to replace cigarettes with a revolutionary portfolio of alternative products. Join us and you’ll have the resources, support and technology you need to break new ground and see ideas come to life. You’ll be surrounded by some of the brightest scientists in their fields, with fast access to subject experts and commercial decision-makers. If you’re creative, courageous and ready to take risks, you can make a huge impact and propel your career in an endless number of directions. Ultimately, by delivering our smoke-free future, your work could change the lives of a billion smokers. Your ‘day to day’ As a Senior Clinical Scientist you will act as the scientific leader for clinical studies and projects according to study planning, within the Clinical Science & Epidemiology (CSE) department, being also responsible to develop and review documents in line with ICH/GCP, provide scientific/clinical input and expertise to the team and support the clinical operations. More specifically, you'll • Lead the development of clinical study documents (protocol and amendments, summaries, fact sheets and reports) including drafting and review process until approval. Provide input to study documents with scientific content: Inform Consent Form, Statistical Analysis Plan (SAP), Case Report Form, laboratory and analytical documentations. Review study data in line with Data Review Plan and clinical results: tables, figures, listings (TFLs) according to the SAP. • Ensure that the study documentation is developed following ICH-GCP, with respect to subject assessment of eligibility, enrollment, clinical safety (adverse events, serious adverse events), data consistency, as well as the quality management system (QMS) applicable to the PMI R&D environment. • Participate to clinical operations activities requiring scientific input (internal and external meetings, investigator meetings, discussions with CRO/vendors/third parties). Contribute to the clinical assessment team activities (assessment plans, presentations, publications and literature searches), interact with other functions, external partners and 3rd parties. Collaborate with the clinical study, regulatory, quality and safety teams for the resolution of issues and crises. • Raise relevant information, ensure feedback is sought and a solution is achieved with no delay. Collaborate to write, review and update of SOPs/WKIs related to assessment activities. Work on the registration and publication of clinical studies/results on ClinicalTrials.gov and prepare the publication of results in peer-reviewed journals. Who we’re looking for • MD, PharmD or PhD (preferred) or equivalent skills through demonstrated experience. • Substantial experience in clinical research (academic, pharmaceuticals, medical devices, CRO), in planning, execution and reporting of studies. Thorough knowledge of clinical research, ICH/GCP, trial documents, design and regulatory processes. • Good understanding of statistics. Proficient in performing literature review and familiar with document storage/systems, working according to a QMS • Proficient in MS Word, PowerPoint and Excel • Fluent in English, both written and spoken. What we offer Our success depends on the men and women who come to work every single day with a sense of purpose and an appetite for progress. Join PMI and you too can: • 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. As with many countries, Switzerland has immigration restrictions which will impact the possibility for non-nationals to work in the country. Profiles required for this position may not being specific enough to justify the recruitment of a person outside of Switzerland or countries having agreed upon free movement with Switzerland, please note that in this case a valid Swiss work permit or Swiss or EU-25 EFTA citizenship is required to apply for this position. Senior Clinical Scientist – Neuchatel, Switzerland 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 smoke-free products with the power to improve the lives of a billion smokers worldwide. 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. It’s so rare in R&D that everything aligns to create the ideal conditions for outstanding work. Right now, at PMI, that’s exactly what’s happening. R&D is the driving force for our bold new vision: to replace cigarettes with a revolutionary portfolio of alternative products. Join us and you’ll have the resources, support and technology you need to break new ground and see ideas come to life. You’ll be surrounded by some of the brightest scientists in their fields, with fast access to subject experts and commercial decision-makers. If you’re creative, courageous and ready to take risks, you can make a huge impact and propel your career in an endless number of directions. Ultimately, by delivering our smoke-free future, your work could change the lives of a billion smokers. Your ‘day to day’ As a Senior Clinical Scientist you will act as the scientific leader for clinical studies and projects according to study planning, within the Clinical Science & Epidemiology (CSE) department, being also responsible to develop and review documents in line with ICH/GCP, provide scientific/clinical input and expertise to the team and support the clinical operations. We are conducting GCP clinical studies and now also focusing on consumers’ needs and interests; you will design “out-of-the-box” studies / work on research to support consumer’s claims. More specifically, you'll • Lead the development of clinical study documents (protocol and amendments, summaries, fact sheets and reports) including drafting and review process until approval. Provide input to study documents with scientific content: Inform Consent Form, Statistical Analysis Plan (SAP), Case Report Form, laboratory and analytical documentations. Review study data in line with Data Review Plan and clinical results: tables, figures, listings (TFLs) according to the SAP. • Ensure that the study documentation is developed following ICH-GCP, with respect to subject assessment of eligibility, enrollment, clinical safety (adverse events, serious adverse events), data consistency, as well as the quality management system (QMS) applicable to the PMI R&D environment. • Participate to clinical operations activities requiring scientific input (internal and external meetings, investigator meetings, discussions with CRO/vendors/third parties). Contribute to the clinical assessment team activities (assessment plans, presentations, publications and literature searches), interact with other functions, external partners and 3rd parties. Collaborate with the clinical study, regulatory, quality and safety teams for the resolution of issues and crises. • Raise relevant information, ensure feedback is sought and a solution is achieved with no delay. Collaborate to write, review and update of SOPs/WKIs related to assessment activities. Work on the registration and publication of clinical studies/results on ClinicalTrials.gov and prepare the publication of results in peer-reviewed journals. Who we’re looking for • MD, PharmD or PhD (preferred) or equivalent skills through demonstrated experience. • Substantial experience in clinical research (academic, pharmaceuticals, medical devices, CRO), in planning, execution and reporting of studies. Thorough knowledge of clinical research, ICH/GCP, trial documents, design and regulatory processes. • Experience in consumer’s research and claims in fields such as, for example, wellbeing or cosmetics, would be a great added value. • Good understanding of statistics. Proficient in performing literature review and familiar with document storage/systems, working according to a QMS. • Proficient in MS Word, PowerPoint and Excel • Fluent in English, both written and spoken. What we offer Our success depends on the men and women who come to work every single day with a sense of purpose and an appetite for progress. Join PMI and you too can: • 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. As with many countries, Switzerland has immigration restrictions which will impact the possibility for non-nationals to work in the country. Profiles required for this position may not being specific enough to justify the recruitment of a person outside of Switzerland or countries having agreed upon free movement with Switzerland, please note that in this case a valid Swiss work permit or Swiss or EU-25 EFTA citizenship is required to apply for this position. # LIJobs

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