Medical Officer, Centralised and Clinical Trials Licensing
The Medical Officer (MO) delivers clinical assessments, including an end-to-end benefit-risk analysis, for products authorised through the centralised EU mechanism and for clinical trials. This involves making informed decisions from complex scientific data (efficacy, safety, pharmacology, quality, and non-clinical data) on the overall benefit-risk analysis of a medicine and clinical trials. The main therapeutic areas the MO will focus on will be Respiratory, Dermatology, Ophthalmology, Oncology for clinical trials as well as ATMPs and rare diseases. A third level degree (NFQ level 8) in Medicine registerable with the Medical Council of Ireland is essential for this role.

Responsibilities

• Lead the assessment of efficacy and safety data for marketing authorisation, variations, or renewals, compiling detailed assessment reports
• Lead the analysis of risk-benefit profiles and make recommendations for approval/rejection
• Lead the development of internal guidelines and standards in one or more therapeutic focus areas
• Provide peer review of clinical assessment reports. Assist in ensuring assessment procedures remain up-to-date with National, European, and International regulations
• Collaborate with multi-disciplinary assessors (pharmacokinetic/pharmacodynamic, statistical, non-clinical, quality)
• Conduct technical liaison with applicants, regulatory authorities, and healthcare professionals
• Represent the organisation on national and international bodies
• Proactively contribute to the identification, development, and implementation of capability requirements for clinical assessment, including upskilling in benefit-risk analytical principles

• A 3rd level degree (NFQ level 8) in Medicine registerable with the Medical Council of Ireland
• A minimum of 5 years of clinical experience (after becoming entitled to full registration)
• Professional membership examinations awarded in any specialty or discipline
• An additional undergraduate or post-graduate qualification (NFQ levels 7-10) in a relevant scientific or related discipline

• Strong clinical research experience (design, conduct, and interpretation of clinical studies)
• Excellent critical appraisal and data analysis abilities in medical science
• Experience in conducting literature reviews
• Experience with risk-benefit analysis, risk assessment, and risk minimisation analysis
• Demonstrated ability for technical scientific report writing, presentation, and communication
• Strong problem-solving, decision-making, and time management skills

• Experience with the evaluation of medicines in the pharmaceutical industry, regulatory, government authority, academic, or clinical situation
• Published clinical research in the academic or clinical area
• Clinical pharmacology and drug development knowledge
• Good understanding of methodology and biostatistics in pharmaceutical medicine
• Experience of representing an organisation at National and/or European level