Details

Contract

Full-Time

Location

Neuchatel, Switzerland

Department

Life Sciences

Openings

1

Job ID

44385865

Senior Clinical Pharmacologist – 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. We’re also exploring new categories, looking beyond nicotine to develop a new portfolio of innovative products. 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 and beyond nicotine future, your work could change the lives of millions. Your ‘day to day’ As a Senior Clinical Pharmacologist you will provide strategic input for early phase clinical studies within a cross functional team and lead the clinical development programs of new therapeutic business opportunities to achieve target product profile in various therapeutic indications, contribute to the communications with global regulatory agencies, perform dose selection, design and interpretation of all translational phase I studies, define the relationship between drug exposure and efficacy outcomes, and identify populations that may be at risk of increased toxicity or decreased tolerability. Be responsible for scientific aspects of therapeutics GCP clinical studies, write key clinical sections of regulatory documents and reports to upper management. More specifically, you'll • Supervise the design of early phase translational pharmacology studies for therapeutics across multiple disease areas to advise next phases of drug development. Critically evaluate relevant pharmacokinetics/pharmacodynamics data across in vitro, in vivo, and drug metabolism studies for clinical study design to be part of the clinical development program. Identify relationship between drug exposure and efficacy outcomes and select the efficient dose & dosing intervals from review and interpretation of PK/PD data. • Lead the selection, design, development/review of core clinical study documents and interpretation of data from early phase. Be responsible for the scientific aspects of studies and be the point of contact for CROs and investigators in day-to-day needs. Review and provide input to internal and external documents with scientific content, participate in data review process according the Data Review Plan and review results. • Actively support the clinical team activities when necessary requiring scientific input, as well as ensuring interactions with regulatory, quality, legal departments, contribute to the resolution of issues and crises, keep effective communication among peers, ensure that issues, or relevant information, are raised and that feedback is sought, where needed, and a solution to open actions is achieved. • Ensure that the clinical study documentation is developed following standard clinical research practices (ICH-GCP) as well as the quality management system applicable, participate in the writing, review, and update of SOPs and WKIs related to clinical assessment activities. • Conduct data analyses including non-compartmental analyses, modelling and simulations, literature data analyses. Investigate, identify, develop, and optimize new methodologies and techniques in PK/PD field. Lead the writing of regulatory documents for clinical pharmacology sections. Contribute to provide scientific information for the registration / publication of results on ClinicalTrials.gov and in peer-reviewed journals. Who we’re looking for • Scientific degree (PharmD or PhD). • Substantial experience in a Translation medicine, PK, population PK (PBPK), PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters, clinical pharmacology and Modeling & Simulation (M&S), in GCP studies phase I&II, within the pharmaceutical, food, life sciences industry. • Familiarity with quantitative approaches in drug development, good understanding of relevant modeling software (e.g. NONMEM, ADAPTII, WinNonlin, Berkeley Madonna, R, S-Plus, SimCYP, GastroPlus). Understanding of basic statistical methodologies, proficiency in performing literature review, familiarity with document storage and systems, expertise in working according to a quality management system and GCP. • Proficient with Excel, PowerPoint, and Word. • 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. #LIJobs

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