Clinical Research Scientist
- Date de publication
Our partner company, a market leader in Life science sector, is currently looking for a Clinical Research Scientist.
Clinical Research Scientist
Your mission ?
• Serve as clinical research representative for specific R&D categories to develop mid-to-long term strategic clinical plan by designing and delivering brand- & ingredient-specific clinical studies under specific clinical plan.
• Independently design/write scientific content of study protocol and other key study documents in collaboration with statistician, data manager, medical director, clinical project manager (CPM) and other key stakeholders, and timely trial registration.
• Select study site/investigator and vendor in terms of medical/scientific/research credibility; Create scientific presentation materials and provide protocol, medical and safety training to them.
• Provide clinical / scientific review and approval of clinical trial database, statistical analysis plan, and statistical report; Responsible of clinical data review, interpretation and topline data rollout to R&D and broader multidisciplinary teams; Independently author R&D study reports used for regulatory filings.
• Present clinical study results at scientific conferences and symposia; Author publications (including abstracts and manuscripts) and/or critically review and approve manuscripts developed by external medical writer; Develop publication strategic plan for the responsible categories.
• Work independently and cross-functionally for the development of study concept and methodology for obtaining Group approval, and to ensure R&D and business alignment and scientific rigor in market initiated studies; Oversee the medical / safety design and execution of study in compliance with GCP/ICH, Company policies and applicable local regulations.
• Provide scientific/medical content for clinical messaging development; Apply strong clinical and Life science knowledge and clear understanding of business need to identify research trends/gaps, market opportunities, solutions and novel technologies, and contribute to innovation/renovation ideation, IP generation, and R&D development work.
• Develop effective partnership with global & regional scientific and medical experts; Reach and engage external experts in the field to identify, pursue and develop research collaborations; Partner with Clinical Operations, external CROs, and laboratory vendors to ensure best practice in executing and delivering clinical trials on time, on budget, and with high quality results.
Your Profile :
• PhD degree life sciences or equivalent
• At least 3 years of proven experience in designing and delivering clinical studies, protocol development, research methodology and clinical data interpretation combined with solid publication record
• Proven ability to provide in-depth scientific input into the development of clinical research portfolio strategy
• Proven ability to interpret and synthesize clinical data / statistical results in study summary report, write scientific abstracts and manuscripts, and present study results to internal R&D & business teams as well as to external scientific community
• Experience planning, executing, and managing global clinical trials
• Fluency in English and in French
Vous reconnaissez-vous ?
If you are interested in this opportunity, please feel free to apply online. Looking forward to hearing from you soon.