Our client is a Biotech company with an exciting pipeline of drug compounds in development, now have approval for a newly created role of Clinical Development Lead for early-stage and late-stage studies. This hire will be based in Ireland or EU region, working remotely from their own home office when not traveling. The majority of travel will be in EU region.
The successful hire will support design and execution of clinical studies, and development plans, to promote scientific excellence and regulatory compliance. In this hands-on role, you will work closely with Clinical Operations, Regulatory Affairs, CMC, Nonclinical, and other functions.
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:
- 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.
- Scientific and strategic mindset, with proven experience in clinical execution.
- Experience in clinical trial design, protocol development, logistics, and evaluation.
- Strong analytic capability, and eager to continuously develop own scientific and medical knowledge.
- Ability to effectively present complex data and strategy to large groups.
- Proven 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.
- Superb communicator of technical and scientific information, multilingual a plus.
- Demonstrates good medical / scientific writing skills.
- Exhibits high motivation and high energy level, self-starter.
- Able to travel within the EU region.
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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