Clinical Development Director
Sam Whyley-Smith at CK Clinical is recruiting for a Clinical Development Director to join a highly innovative Biotechnology Company focused in the development of cutting edge Gene Therapies based in either Stevenage or Central London on a permanent basis.
The main purpose of the role will be to:
- Lead the design of clinical development strategy and direct the implementation of clinical trials of gene therapies in ophthalmic indications.
- Provide safety oversight, clinical contribution to regulatory documents, analysis of study results, and preparation of reports for assigned programmes.
- This position will report into the VP of Clinical Development.
Further responsibilities will include:
- Lead clinical development programme strategy for assigned programme(s).
- Develop expertise in clinical and translational outcomes and endpoints and contribute to the translational research strategy.
- Lead activities relating to clinical study design, preparation of protocols, clinical trials oversight, data analyses and written study reports.
- Support business development and assessment of opportunities for in-licensing and collaboration.
- Collaborate with external partners: CROs and other vendors, including image reading centres, academic partners, industry groups.
- Provide medical input to Competent Authority and Ethics Committee/IRB submissions and support interactions with same.
- Develop and maintain relationships with KOLs and investigators, develop a broad network of experts in the ophthalmology space.
- Provide medical monitoring oversight and serve as the primary contact for the medical review of safety reports for pharmacovigilance.
- Mentor Clinical Project Managers to assure medical training on the indication of interest.
To succeed in this role, you will have the below background:
- Professional credentials as a physician (MD) or equivalent (e.g. OD, PharmD).
- Minimum of five years of clinical development experience.
- Experience in ophthalmology or rare diseases is a positive, but is not required.
- Experience in global drug development.
- Translational medicine or early clinical research experience.
- Thorough knowledge of clinical trial processes including a strong grasp of international guidelines and regulations (FDA, ICH, and GCP).
For more information or to apply for this position, please contact Sam Whyley-Smith on 01246 580040 or email email@example.com. 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 46836 in all correspondence.