Head of Clinical Operations (home-based)

Proclinical are recruiting a Head of Clinical Operations to join a biotech establishment with the ability to be home-based with occasional visits to the office located in Cambridge.

Responsibilities:

• Strategic oversight of all of the company's clinical studies, including co-ordination with Clinical sciences to ensure study designs are appropriate and operationally astute, within budget and overall corporate objectives.
• Highlight clinical operational impact of any proposed changes to COO.
• Provide comprehensive insight including legal provisions into all clinical contracts including initiation, review and negotiation, modification, contract resolution and termination - drive all contracts to approval.
• Provide detailed control of clinical trial budget including tracking of variance vs budget and highlighting potential changes in real time to COO/FD, in conjunction with the Development Project Manager and CPM.
• Provide oversight and support to CPM to ensure optimal implementation of clinical studies.
• Review all information detailed in the clinical sections of regulatory documents. such as IBs/briefing books/safety updates/CTA/BLA submission documents, responses to Health Authority (HA) questions, etc. as needed.
• Have oversight of trial operational plans and systems (e. g. clinical database, IRT.) required for Ethics / Regulatory submissions.
• Ensure these are communicated efficiently and effectively to the COO * Responsible for tracking all trial information databases and tracking systems in order to ensure accuracy of all external information relevant to the company.
• Extensive competitor surveillance in conjunction with Business Development team to evaluate strategic threats to ongoing studies by the company.
• Provide input and guidance to CPM/CTA to ensure inspection / audit readiness including Trial Master File documentation.
• Direct line management responsibilities for CPM & CTA.
• Lead clinical operational development within the organisation.
• The above list is not exhaustive, and you may from time to time be asked to undertake other tasks by your line manager.

Skills & Responsibilities:

• A degree or equivalent education in life science/healthcare.
• Minimum 15 years' experience working in a senior position within Biotechnology and CRO environment - combination of both Biotechnology and CRO is essential.
• Additional business qualifications an advantage.
• Strong contract negotiation experience including legal provisions.
• Highly motivated individual bringing.

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 203 7440 0639.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-MP1

#Clinical