Clinical Evaluator

About the Role

The Clinical Evaluator will be responsible for evaluating the efficacy and safety of medicines based on clinical trial results and scientific literature, with the aim of making them available to patients (clinical trials, Compassionate Access/Early Access, Marketing Authorization) in the cardiology department.

The job holder will work with a range of medicines, including those used in intensive care, antidotes, and other cardiologic treatments. The distribution of these medicines may vary depending on the department's attributions, urgent tasks, and inter-departmental mutualization.

Main Responsibilities

• Evaluate the efficacy data of clinical trials submitted in the context of Marketing Authorization or variations to Marketing Authorization, in European procedures (centralized procedures in French, rapporteur or co-rapporteur; MRP-DCP), or national procedures, to assess the benefit-risk ratio of a specialty
• Evaluate clinical trial protocols and their modifications in the context of their authorization request, for national and European trials, to ensure patient safety and the absence of therapeutic loss
• Evaluate and instruct requests for Compassionate Access (CA), Early Access (EA), and Compassionate Prescription Framework (CPF)
• Exchange with the European Medicines Agency, competent authorities of EU member states
• Evaluate the indispensable nature of medicines in the event of a potential stock rupture. Elaborate recommendations or updates as needed
• Participate in ANSM working group meetings (cardiovascular stock management with CDP) with scientific societies or external experts, the European Agency, and institutional meetings

Secondary Responsibilities

• Develop responses to requests from other ANSM departments, public health institutions, patient associations, pharmaceutical companies
• Manage relationships with external experts, analyze Declarations of Interest, and prevent potential conflicts of interest
• Participate in scientific advisory boards requested by pharmaceutical companies on the clinical development of their molecule
• Write and/or validate scientific content for information support intended for regulatory authorities, other health authorities, healthcare professionals, and the general public (preparation of letters to healthcare professionals, press releases, articles)
• Mutualize therapeutic ranges between ANSM departments based on activity

Requirements

• Education/Qualification: Minimum Bachelor's degree + 5 years
• Required professional experience: Minimum 6 years in the medical, pharmaceutical, or scientific field
• Desirable experience: Clinical data evaluation and medicine safety, knowledge of Marketing Authorization procedures, clinical trials, and early access procedures
• Key skills:
  • Rigorous and methodical approach in multidisciplinary fields (scientific, medical/pharmaceutical, and regulatory)
  • Ability to analyze and synthesize in the scientific field
  • Excellent stress management and prioritization
  • Ability to handle emergencies and varied activities with different calendars, reactivity, and anticipation
  • Excellent written and oral communication skills (in French and English)
  • Teamwork and networking skills
  • Ability to transmit knowledge, particularly in the context of mentoring students
  • English proficiency, oral and written, to defend files at the EMA as needed
  • Knowledge of Microsoft Office (Word, Access, Excel, PowerPoint) and the Internet