Senior Clinical Scientist — End-to-End Trials Leader

CSL Plasma Inc.; Thatcham; On-site; GBP 90,000 - 130,000; Full time

Job summary

CSL Seqirus is seeking a Principal Clinical Scientist to lead clinical studies end-to-end, from protocol development to study execution and close-out, with co-ownership of regulatory submissions where applicable. The role partners with operations and CROs in a full-outsource model to drive study success and data integrity across global sites.

Hybrid working pattern is offered, with on-site presence three days per week in Maidenhead, UK, plus potential involvement in Australia and Europe.

Qualifications

• Hands-on experience leading clinical studies end-to-end.
• Experience writing clinical study protocols and final study reports.
• Experience working within a full-outsource / CRO-dependent operating model.
• Collaborative, cross-functional working style with global teams.

Responsibilities

• Take ownership of clinical studies end-to-end, acting as the scientific and operational anchor between the program team and outsourced delivery partners.
• Lead all scientific elements of clinical studies from protocol development through study execution to a final clinical study report.
• Write and/or take responsibility for study protocols, clinical study reports and other critical study documents.
• Manage day-to-day CRO relationships under a full-outsource operating model alongside the clinical operations lead.
• Collaborate with cross-functional study teams and contribute to scientific interpretation of data.
• Build working relationships across the wider team, including colleagues in the US and Australia.

Skills

Clinical studies leadership

Protocol development

CRO/vendor management

Regulatory submissions

Job description

CSL Seqirus is seeking a Principal Clinical Scientist to lead clinical studies end-to-end, from protocol development to study execution and close-out, with co-ownership of regulatory submissions where applicable. The role partners with operations and CROs in a full-outsource model to drive study success and data integrity across global sites.

Hybrid working pattern is offered, with on-site presence three days per week in Maidenhead, UK, plus potential involvement in Australia and Europe.