Clinical Scientific Expert
Our client, a growing biopharma start up are currently recruiting for a Clinical Scientific Expert to join their Clinical Science team on a permanent basis. As Clinical Scientific Expert you will support the design and execution of clinical studies and development plans while meeting standards of excellence for ethics, scientific merit and regulatory compliance. This includes protocol design, outsourcing partner management, oversight of operational activities, results reporting, analysis and interpretation. This role can offer hybrid working.

Responsibilities:

• Support the development of clinical study synopses/protocols for early and late-stage clinical development studies
• Medical and safety monitoring of clinical trials to current scientific, ethical, and regulatory standards
• Ensuring study integrity and that all aspects of the protocol are implemented consistently across the study
• Hands on reporting, analysis and interpretation of clinical study data
• Interacting and seeking input from external partners/experts
• Contributing to the development of study-level documents including clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers
• Support and present at study level meetings (Investigator Meetings, Data Monitoring Committee (DMC) meetings or others), as required

Requirements

• MD or PhD in pharmaceutical sciences/clinical pharmacology or PharmD with proven academic excellence – experience with clinical pharmacology studies is preferable
• Several years of scientific, strategic, and operational experience in planning, executing, reporting, and publishing clinical studies in CNS pharma, ideally within depression
• Experience as a medical expert performing medical and safety monitoring
• Excellent understanding of ICH GCP and up-to date on regulatory requirements
• Hands-on s and a preference for staying close to clinical execution while also being able to bring a scientific and strategic perspective
• Demonstrates good medical / scientific writing skills
• Knowledge of principles of clinical data collection and reporting; ability to use systems and tools (e.g., EDC systems, Excel, etc.) for data collection, analysis, and reporting
• Experience in the management of outsourced development programmes
• A blend of conventional pharma plus biotech experience and the attitude and ability to be effective in a lean, small company environment
• Experience in working and influencing cross-functionally
• Proven aptitude in continuously developing own scientific and medical knowledge including strong analytic capability
• Flexible, able to adjust, embrace and drive change
• An entrepreneurial, business-oriented mindset team and willing to “roll their sleeves up”
• Resilient, energetic and enthusiastic

For more information please contact Sinéad Cullen on +353879500821 or sinead.cullen@lifescience.ie