APX Life Sciences are partnered with a small biotech in the UK that are looking for an experienced Senior Clinical Research Scientist to join their growing clinical operations team in a remote position.
Our client has multiple assets currently in development from pre-clinical through to Phase III, across various therapeutic indications, along with a solid financial backing. As you can tell, this is an exciting time to join this company and be a part of their growth long term where you’ll make huge impact.
They’re flexible on therapy area backgrounds and are looking for someone who can hit the ground running straight away, so ideally someone with at least 3-5 years Clinical Development/ Science experience gained within a biotech/ pharma is needed.
Responsibilities:
* 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.
* 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.
* 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).
* 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.
* Contribute to the risk management plan, and support set up of adaptive risk monitoring systems with the study team as applicable.
Requirements:
* PhD or equivalent degree in relevant scientific field
* 3-5 years’ experience in clinical development
* Some biotech experience is preferred
* Strong understanding of clinical trial design
* Demonstrated ability to analyse complex clinical data and translate findings into actionable insights.