Job Description
Cambridge-based Nxera Pharma UK Limited, a technology powered biopharma company, seeks an R&D Project Manager to lead their early-stage clinical strategy for their GI/Immunology programme.
* The ideal candidate will contribute to early clinical strategy and provide clinical translational leadership, designing and executing early-phase clinical trials with integrated biomarker strategies.
* Serving as the medical expert for IBD clinical trials, they will ensure the safety and well-being of trial participants and review adverse events, ensuring compliance with protocols, GCP, and regulatory requirements.
* The successful candidate will engage with investigators and key opinion leaders (KOLs) to provide medical and scientific guidance throughout the trial lifecycle.
* They will implement, manage, and interpret clinical trial results and exploratory biomarker endpoints to inform clinical strategy.
* 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 a competitive day rate and opportunities for collaborative work in innovative therapeutic development.