Job Description
Nxera Pharma UK Limited, a biopharma company leveraging technology to drive innovation, seeks an expert in clinical development to lead their early-stage strategy for the GI/Immunology programme.
* The ideal candidate will develop and execute early-phase clinical trials with integrated biomarker strategies, ensuring safety and compliance with regulatory requirements.
* As a medical expert for IBD clinical trials, they will oversee trial participants' well-being, review adverse events, and provide medical guidance throughout the trial lifecycle.
* They will collaborate with investigators and key opinion leaders (KOLs) to inform clinical strategy, implementing and interpreting clinical trial results and exploratory biomarker endpoints.
* A strong understanding of regulatory requirements is essential, including experience in MHRA, FDA, and EMA interactions.
Key qualifications include:
* An MD or equivalent medical degree with extensive experience in early-phase clinical development.
* Proven expertise in GI and immunology therapeutic areas, with a focus on Inflammatory Bowel Disease (IBD).
* Demonstrated success in designing and executing clinical trials with biomarker integration and translational strategies.
* Experience working within a small biotech environment, showcasing adaptability, resourcefulness, and the ability to manage multiple responsibilities in a fast-paced setting.
Nxera Pharma offers opportunities for collaborative work in innovative therapeutic development.