BioTalent are excited to partner with a biotechnology client developing RNA-editing medicines for patients with rare and common diseases in recruiting a clinical scientist for their team. This position will support the design, execution and analysis of clinical trials and work cross functionally to ensure scientific integrity and operational excellence in company sponsored trials.
Your responsibilities will include:
Clinical Trial Design & Protocol Development
* Assist in or lead the design of clinical study protocols and amendments
* Write or contribute to study-related documents (e.g., IB, informed consent forms, CRFs, recruitment materials)
Study Execution Support
* Provide scientific and clinical input during trial conduct
* Monitor data for consistency, completeness, and potential safety/efficacy signals
* Collaborate with CROs, sites, and internal teams to resolve study-related issues
* Build relationships with sites including PIs and clinical trial site staff, supporting their start up activities and patient recruitment activities
Data Analysis & Interpretation
* Review clinical trial data in collaboration with data management and biostatistics
* Interpret data in the context of the disease, target, and competitive landscape
* Contribute to clinical study reports and documentation for regulatory submissions
Cross-functional Collaboration
* Work closely with Clinical Operations, Medical Monitors, Pharmacovigilance, and Regulatory Affairs
* Participate in clinical development plan creation and updates
* Present study results and strategy to internal stakeholders and internal governance bodies
Regulatory & Safety Input
* Support preparation of INDs, NDAs, CTAs and other regulatory documents
* Provide input into safety review processes and risk-benefit assessments
Ideally, you will have:
* An advanced degree in life sciences or health discipline (PhD, Pharmacy degree, MD, or MS with relevant experience)
* 2–6+ years of industry experience in clinical development and/or clinical operations
* Strong knowledge of ICH GCP and clinical trial methodology
* Ability to critically evaluate scientific data and literature
* Strong communication skills (verbal and written)
* Ability to manage multiple priorities and collaborate across functions
* Experience in rare disease
* Familiarity with working with and supporting clinical trial sites for study start-up and recruitment
* Working knowledge of clinical trial site monitoring
* Ability to travel to clinical trial sites and build relationships with PIs and clinical trial site staff
LOCATION: This is a remote position that will require travel to sites. A candidate based in Europe/UK is preferred