Our client is a Biotech company with an exciting pipeline of drug compounds in development, now have approval for a Clinical Science Liaison role within the Clinical Science team, for early-stage and late-stage CNS studies. This hire will be based in Ireland or the UK, with some office presence required when not traveling. Travel is required, mainly in the EU region.
The key responsibilities of this role include supporting design, planning, execution, reporting and publishing of clinical studies. This hire will maintain a scientific and strategic focus, towards clinical execution through liaison and oversight of clinical studies with internal and external colleagues and stakeholders.
In this hands-on role, you will work closely with Clinical Operations, Regulatory Affairs, CMC, Nonclinical, and other functions and partners, leading development plans to promote scientific excellence and regulatory compliance.
This hire will contribute to the documentation of the clinical development programs and the overall product development and evaluating the efficacy and safety of drug candidates in human studies.
Key responsibilities include:
- Leading protocol design, development, vendor management (including CROs, etc.), data analysis, results reporting, etc.
- 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.
- Build out relationships with KOLs / OLs, PIs, study investigators and research staff to ensure full engagement throughout the course of the study and where appropriate, work with patients’ groups, scientific organizations, and advocacy organizations.
- Work with the clinical investigators and site staff to provide education, support enrollment and retention initiatives, disseminate product/trial information, represent company interests and provide scientific intelligence.
- Supporting and presenting at study level meetings (Investigator Meetings, Data Monitoring Committee (DMC) meetings or others), as required.
- PhD or other Doctoral level degree (e.g., MD, PharmD) required.
- 5+ years of relevant clinical research / clinical development experience, working to ICH/GCP guidelines in the biotech or pharmaceutical industry, or clinical setting is preferred.
- Clinical Pharmacology and / or Medical and Safety Monitoring experience within Clinical Research is highly desirable.
- 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
- Demonstrates good medical / scientific writing skills.
- Experience in clinical trial design, protocol development, logistics, and evaluation.
- Knowledge of compliance and regulatory requirements in clinical trials and drug development.
- Superb communicator of technical and scientific information, multilingual a plus.
- Able to travel within the EU region and EU regional passport as required.
- Ability to effectively present complex data and strategy to large groups.
- Exhibits high motivation and high energy level, self-starter.
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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