Job Description
Candidates with expertise in clinical development, particularly in phases 1 and 2, are sought after to lead early-phase clinical trials in the gastrointestinal (GI) and immunology therapeutic areas.
About CK Group
CK Group is working in partnership with Nxera Pharma UK Limited, a technology-powered biopharma company pursuing new specialty medicines to improve the lives of patients with unmet needs in Japan and globally.
Responsibilities
* Contribute to strategic planning and provide leadership in designing and executing early-phase clinical trials with integrated biomarker strategies for GI/immunology programs.
* Serve as a medical expert for IBD clinical trials providing ongoing medical monitoring and ensuring the safety and well-being of trial participants.
* Review and assess clinical data including adverse events and ensure compliance with protocols GCP and regulatory requirements.
* Provide medical input into study protocols Investigator Brochures informed consent documents and clinical study reports.
* Engage with investigators and key opinion leaders (KOLs) to provide medical and scientific guidance throughout the trial lifecycle.
* Implement manage and interpret clinical trial results and exploratory biomarker endpoints to inform clinical strategy.
Requirements
* MD or equivalent medical degree with extensive experience in early-phase clinical development particularly in phases 1 and 2.
* Proven expertise in GI and immunology therapeutic areas with a strong focus on Inflammatory Bowel Disease (IBD).
* Demonstrated success in designing and executing clinical trials with biomarker integration and translational strategies.
* Experience in working within a small biotech environment showcasing adaptability resourcefulness and the ability to manage multiple responsibilities in a fast-paced setting.
* Strong understanding of regulatory requirements for early-phase trials including experience in MHRA FDA and EMA interactions.
* Excellent communication skills with the ability to engage effectively with internal teams investigators and KOLs.
Benefits
A competitive day rate is offered.