We are advertising on behalf of our client Gyroscope Therapeutics Ltd
VP of Clinical Development
Location: Stevenage, UK
Salary range: £120,000 - £140,000 per annum
About Gyroscope Therapeutics
GYROSCOPE’s mission is to develop cutting edge gene therapies in retinal diseases with high unmet medical need. This mission is based on the convergence of science in understanding of the importance of the immune system in the development of certain retinal diseases, new knowledge about the role of genetics in such diseases and advancements in gene therapy.
The company has already established a strong research team that has completed work on the company’s first candidate and has initiated work on the second programme. In addition to research the company has a world class CMC team and clinical expertise needed to start the first clinical study.
The Company is supported by key experts in the field of ophthalmology, gene therapy, immunology and genetics. GYROSCOPE is funded by Syncona Ltd and Cambridge Enterprise.
Clinical development strategy, translational medicine
· Define clinical development strategies and programmes
· Achieve support for the planned clinical development programmes and establish good relationships with key opinion leaders
· Bring programmes into clinical Phase 1/2 trials, as well as support the medical activities involved with the programmes
· Translate late stage preclinical programmes into a clinical setting with the view of gaining regulatory approval
Clinical trials oversight
· Propose clinical trial design and prepare trial synopses
· Oversee clinical data analyses and the preparation of written clinical trial reports
· Lead and manage the clinical operations team - Interact with CRO and other vendor relationships, as needed
· Drive investigator/site selection and medical expertise at investigator meetings
· Provide medical expertise in connection with regulatory interactions including Competent Authority and Ethics Committee/IRB submissions.
· Prepare clinical sections of regulatory documents, Investigator’s Brochures
· Lead clinical publications plan (abstracts, publications, etc)
· Explore possible new indications for gyroscope platform and pipeline
Education and Experience Requirements:
· Experience with translating preclinical programmes into clinical development
· Professional credentials as a physician (MBChB or MD)
· Significant experience of early clinical development, Phase 1/2
· Experience in running gene therapy trials an advantage
· Experience in managing multiple, concurrent projects
· Knowledge of international clinical trial approval processes
· Experience in presenting the clinical development strategy to competent authorities (for example, FDA, EMA, national agencies)
· Ability to be both strategic and hands-on, adaptable to small/medium size pharma companies
· Excellent oral and written communication skills as well as the ability to facilitate analysis and problem solving through the effective facilitation of group activities
· Strong organisational and time management skills including the ability to function effectively in a team environment
· Demonstrated professionalism and adherence to high ethical standards
· Demonstrated ability to manage multiple priorities to achieve results and meet milestones in a “hands- on” fashion.
Remuneration and Benefits
For the successful candidate there will be an excellent remuneration package including access to a discretionary bonus element based on company performance, and a discretionary equity incentive.
The closing date for applications is 28 February 2018
Please note Hobson Prior is working exclusively on this vacancy