Director Clinical Development - Ophthalmic Rare Disease
- Experience Level
- Experienced (non-manager)
I am exclusively partnered with an exciting clinical-stage biotech company with a world-class management team who are currently seeking a Senior Physician to lead the global Clinical Development department within rare ophthalmic disease.
You will be responsible for directing all aspects of the design of clinical studies, the implementation of clinical trials, and preparation of reports relating to clinical trial outcomes.
· Lead the clinical-stage programs and bring forward other pipeline programmes into the clinic
· Formulate early phase clinical development programmes, including recommendation of primary and secondary end points, biomarkers and inclusion/exclusion criteria with the view of gaining regulatory approval
· Direct all aspects of activities relating to preparation of protocols, clinical trials, data analyses, safety evaluation and clinical study reports, including being the program lead and medical monitor for clinical trials
· Execute medical review of individual case safety reports and aggregate safety data, and participate and contribute to safety surveillance activities, safety processes and safety development
· Review periodically clinical data and present them to internal and external audience including DMC meetings and investigators’ meeting
· Professional credentials as a physician (MBChB or MD)
· Significant experience of clinical development in pharmaceutical industry
· Experience in ophthalmology desired
· Experience working in small biotech/start-up and/or rare diseases an advantage
· Working knowledge of clinical trial approval processes including a strong grasp of international guidelines and regulations (FDA, ICH, and GCP)
· Demonstrated ability to manage multiple priorities to achieve results and meet milestones in a “hands-on” fashion
· Competitive basic salary
· Exciting and innovative work environment
· Flexible working arrangements
· Attractive holiday allowance
· Opportunity to work on game-changing therapies
For more information, please reach out to Antonia at Barrington James.
+44 1293 776644