Head of Medical Clinical Science
Vor 3 Tagen
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 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 Head Medical Clinical Science, you will act as the medical and scientific leader for clinical studies and projects according to study planning, within the Chief Medical Officer and Clinical Research department, being also responsible to develop and review documents in line with ICH/GCP, provide medical/scientific/clinical input and expertise to the team and support the clinical operations. We are conducting GCP clinical studies in diseased populations and are now also focusing on consumers’ needs and interests; you will build a creative clinical development plan and design “out-of-the-box” studies / work on research to support consumer’s and/or regulatory claims.
More specifically, you'll- Co-build, with the Global Head of Clinical Development and Operations, with your team, with a cross-functional input, the Clinical Development Plans of the different products.
- Lead, efficaciously and efficiently, the development of impactful clinical studies.
- Lead, manage and ensure medical and scientific inputs in the key documents (protocols and amendments, summaries, fact sheets and reports) including drafting and review process until approval. Provide input to study documents with scientific content: Investigator Brochures, Informed 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, enrolment, 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, selection and 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. Work on a cross functional plan for regular scientific and projects updates and data sharing to train and bridge between the teams.
- 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 quickly and efficiently. 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. Contribute to the writing of regulatory dossiers (e.g., investigator's brochures, modified risk tobacco product application, pre-market tobacco product application).
- MD, PharmD or PhD
- Having experience in a specific tobacco-induced disease area, or a Harm Reduction study, could be a plus.
- Substantial experience in cross functional project management in clinical research (academic, pharmaceuticals, medical devices, CRO), in planning, execution and reporting of studies. Thorough knowledge of clinical research, medical review, ICH/GCP, trial documents, design and regulatory processes.
- Good understanding of statistics.
- Proficient in performing literature review.
- Familiar with document storage/systems (e.g. trial master files), working according to a QMS.
- Proficient in MS Word, PowerPoint, Excel, citation manager (e.g. Endnote).
- Fluent in English, both written and spoken.
Our 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.
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