About the Role
Nxera Pharma UK Limited is seeking a highly skilled R&D Project Manager to lead their early-stage clinical strategy for the GI/Immunology programme.
* The successful candidate will be responsible for developing and executing early-phase clinical trials, ensuring compliance with regulatory requirements and overseeing trial participants' safety.
* They will provide medical guidance throughout the trial lifecycle, collaborating with investigators and key opinion leaders (KOLs) 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.
This is an exciting opportunity to join a dynamic team and contribute to innovative therapeutic development.