Description
A leading biopharmaceutical company in Oxfordshire is looking for an Interim Clinical Director to join there team ASAP for a 6 month contract - potentially longer.Main responsibilities:
- Leads all Clinical Operations activities with responsibility for line management, strategic planning and alignment with broader organisational goals.
- Ensures appropriate management of all clinical trials run by the Company in accordance with GCP, relevant ATMP guidelines and all applicable laws and regulations.
- Responsible for performance management of clinical operations staff including performance assessment, annual performance reviews, training programme development, mentoring, coaching, and succession planning.
- Sets overall direction, strategy and performance standards for Clinical Operations staff including contractors to assure that project and departmental financial targets are achieved, including:
- Preparing, reviewing project budgets, monitoring costs, potential overruns and implementing cost effective solutions;
- Developing appropriate early warning systems of impending obstacles to the successful completion of the projects, analysing the information and developing a solution to the challenge;
- Supports and backs up team members as needed;
- Overseeing all departmental development work; for example, document and SOP writing and updating, and process improvement;
- Is prepared to act as Clinical Project Manager on his/ her own specific clinical projects if required;
Required knowledge and skills:
- Higher scientific degree level education preferred
- Line management and departmental management experience within clinical trial arena essential
- Excellent working knowledge of GCP and current global clinical trial legislation
- Advanced Therapy Medicinal Product experience helpful
- Broad clinical project management experience, some of which would ideally have been in a small or medium-sized Pharma company and include phase I studies
- Thorough knowledge of the clinical research process, ideally from first in human through to regulatory filing for marketing
- Neurology/oncology/ocular therapy area experience helpful
- Strong communicator with excellent written and verbal communication and presentation skills
- Self-motivated and enthusiastic; ability to motivate and lead others
- Excellent organisational and interpersonal skills
- Ability to manage multiple priorities across varied projects
- Working knowledge of Microsoft Office - Word, Powerpoint, Excel and Project
- Ability to travel in the UK and abroad periodically if needed.
This is an excellent opportunity to join a fast moving organisation. If you are interested in any in this position and would like some more information please send an updated CV and call Hailey on .
Please also pass this opportunity onto anybody you know who may be interested in this as we do offer £200 referral vouchers.