Director of Clinical Operations in Cambridge
Jim Gleeson is recruiting for a Director of Clinical Operations to join a promising biotechnology company with a strong portfolio of compounds entering First in Human studies.
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.
Key Duties will include:- 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, Biometrics etc) 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.
For more information or to apply for this position, please contact Jim Gleeson on 01438 842973 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46015 in all correspondence.