Position Overview
We are seeking a UK based detail-oriented and experienced Clinical Scientist reporting directly to the VP of Clinical Operations.
Key Responsibilities:
•Clinical Study Design and Execution: Oversee the development of clinical study plans from concept through to protocol finalization, ensuring scientific rigor and alignment with regulatory expectations, healthcare provider needs, patient advocacy perspectives, and market access requirements.
•Clinical Documentation Leadership: Lead the creation and review of essential clinical documentation—including informed consent forms, imaging charters, study manuals, and regulatory dossiers—in collaboration with the cross-functional teams.
•Regulatory and Scientific Contributions: Provide expert clinical input into key regulatory and scientific documents, including Investigator Brochures, IMPDs, DSURs, PSURs, SUSARs, Clinical Study Reports, and global regulatory submissions (e.g., INDs, BLAs, NDAs, MAAs).
•Data Integrity and Analysis: Lead the review, interpretation, and quality control of clinical data, including efficacy, safety, and imaging endpoints, to ensure data integrity and support decision-making across the development lifecycle.
•Applies a risk-based quality management mindset, contributes to the risk management plan, and supports set up of adaptive risk monitoring system with the study team as applicable. Works with all functional leads and sponsor to identify data related issues and risks to clinical activities; assists CLs in the development of mitigation plans to minimize risks
Key Requirements:
•PhD or equivalent degree in a relevant scientific discipline
•Approximately 5 years of industry experience in clinical development, preferably Oncology or rare diseases.
•Strong understanding of clinical trial design, regulatory requirements, and Good Clinical Practice (GCP).
•Excellent communication, collaboration, and leadership skills.
•Demonstrated ability to analyze complex clinical data and translate findings into actionable insights.
•Strong interpersonal and communication skills (written and verbal) for bridging across diverse, cross functional, multi-national, geographically dispersed teams
•Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project
This is a full-time permanent remote position, with 10% travel requirements which include monthly visits to the Cardiff office.
No agencies at this time.