about 2 years ago
Our client is a leading Pharmaceutical company based in North London they are expanding their portfolio and have a substantial pipeline. This is an unusual opportunity to lead a Clinical Development team and provide medical oversight for early and late stage oncology development programmes.
The main responsibilities of the role will be as follows:-
- Design and execution of development plans from preclinical research through to Phase I/II/III Clinical Trials.
- Leading a team of direct reports and cross functional study teams
- Serving as Study Director and driving the execution of the study from protocol concept to final report including interpretation of clinical data
- Serving as the Medical Monitor for a study or clinical program, reviewing and monitoring study safety data
- Implementing strategies to identify, monitor and resolve clinical/program trial issues
- Serving as the clinical/medical team expert to provide direction to all project team functions, organizes Advisory Board meetings and identifying and liaising with KOLs regarding program strategy and scientific advice
- Interpreting study data and developing integrated summaries for safety and efficacy.
- Contributing clinical expertise and content to regulatory documents
- May represent Clinical team in discussions with Health Authorities
- Setting key deadlines and project milestones within function
- Making the appropriate budgetary allocations to targeted opportunities
- Reviewing 3rd party (contractors, consultants and vendors) work product and deliverables to approve payment of invoices and resolves issues.
- Medical Degree
- Industry and / or clinical Oncology experience is essential
- Experience as Medical Monitor and prior experience working with the FDA or EMEA on responses to inquiries for study related information.
- Clinical trial experience in the setting of pharmaceutical industry
Salary and remuneration
• The position offers a highly competitive base salary and package
To apply for this opportunity or to discuss the role further please email email@example.com or call +44 (0)118 900 1100 / +44 (0)07710 673 333