AL Solutions are partnered with a small clinical stage, Oncology focused biotech in the UK that are currently looking for a Clinical Scientist to join their emerging clinical operations team.
My client have an exciting pipeline ranging from studies in pre-clinical through to Phase III, as well as a strong cash runaway offering long-term stability.
We are ideally looking for somone with experience working within Oncology or Rare Diseases, however this isn't a nesesscity.
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
- Strong experience in clinical development
- Oncology or Rare Disease experience is preferred
- Strong understanding of clinical trial design
- Demonstrated ability to analyze complex clinical data and translate findings into actionable insights.
For more information, please submit your application or get in contact with Jack Kavanagh at AL Solutions.
Jack Kavanagh
AL Solutions