Sr Clinical Scientist / Clinical Development

Conteúdo do emprego

Sr Clinical Scientist / Clinical Development – Neuchatel, SwitzerlandBe 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 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 ‘day to day’As a Sr Clinical Scientist / Clinical Development, you will act as the scientific leader for assigned clinical studies and clinical projects according to study planning within the Scientific and Medical Affairs department, be accountable for the development and review of clinical documents in line with ICH/GCP and provide scientific/clinical input and expertise of study design to the study team and supports the clinical operations and Scientific and Medical Affairs in a timely manner.More specifically, you’ll

• Work according to the clinical development plan as approved, to lead the development of core clinical study documents including protocol summaries, study protocols, study fact sheets, protocol amendments, and study reports; this encompasses drafting and reviewing process until final documents approval.
• Review and provide input to internal and external clinical study documents with scientific content, including among others, Informed Consent Form, Statistical Analysis Plan (SAP), Case Report Forms, laboratory, and analytical documentations.
• Participate in the review of clinical study data according to the Data Review Plan (DRP) and in the review of the clinical results such as tables, figures, listings (TFLs) and other analyses according to the SAP.
• Ensure that the study documentation is developed following standard clinical research practices (ICH-GCP), in particular with respect to subject assessment of eligibility, enrollment, clinical safety (adverse events, serious adverse events), data consistency, as well as the quality management system applicable to the PMI R&D environment.
• Support and actively participate in clinical operations activities requiring scientific input such as internal and external meetings including Investigator meetings, discussions with CRO/vendors/third parties, etc., actively contribute to the clinical assessment team activities (e.g. assessment plans, presentations, publications, literature searches), duties, interactions with other functions, externally and/or 3rd parties, support the clinical study team and other functions (regulatory, quality, safety) for the resolution of issues and/or crises.
• Keep effective communication among peers, ensure that issues, or relevant information, are raised and that feedback is sought, where needed, and a resolution to open actions is achieved with no undue delay.
• Participate in the writing, review and update of SOPs and WIKIs related to clinical assessment activities according to the function and role.
• Strive to keep the highest scientific standards, to keep timelines respected, and, promptly flag any potential timeline delays, keep deliverables quality as close as possible to standards required, prioritize tasks and react efficiently within tight timelines in a matrix environment.
• Work collaboratively cross functionally and with external – investigators
• Present study proposals and study programs and results internally and externally

Who we’re looking for

• Degree MD, MD/PhD, or PhD in Clinical Sciences/ Life Sciences
• Expertise and experience in clinical research development (in Academic, Pharmaceutical/Biotech CROs).
• Extensive knowledge of clinical trial design; basic statistics. Demonstrated experience in all aspects of the clinical development process. Sound knowledge of GCP and ICH. Understanding of regulatory requirements.
• Sound experience in medical or technical writing and study report preparation. Extensive medical/scientific and clinical research knowledge, including proficiency in literature review. Good knowledge of protocol development, implementation and proficient at data interpretation.
• Ability to work in a cross functional environment and effectively communicate in a global environment. Excellent interpersonal, communication, and presentation skills in English (written and verbal).
• Proficient in Microsoft Word, Excel, PowerPoint; Microsoft Project is a plus. Demonstrated experience working with electronic data capture systems.
• Travel required.

What we offerOur success depends on the people 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 a smoke-free future.