As Director of Clinical Operations you will build the operational support function to take a number of compounds through the clinical development process. This will be a highly strategic role, establishing key operational policies and building a team to implement them.
- Oversight of clinical studies from panning to close-out whilst ensuring total compliance with ICH-GCP regulations and FDA/EMEA requirements.
- Development and maintenance of key clinical operations SOPs.
- Leading the evaluation, selection and management of CROs and other external vendors.
- Close collaboration with other clinical functions (Translational Medicine, Clinical Supplies, Biometricsetc) to ensure successful delivery of studies.
- Participation in the development of regulatory filings.
- Leading, planning and executing clinical investigator meetings, study meetings and vendor meetings as necessary.
As Director of Clinical Operations you will require the following:
- A relevant post-graduate degree.
- Extensive clinical drug development research experience gained using outsourced service providers.
- Experience of managing clinical programs, CROs, budgets and timelines.
- An understanding of the drug development process from pre-CTA through to filing.
- The ability to respond flexibly to changing program needs in real time.