Description
Company Description
Novai is a Reading-based fast growing biotechnology start-up, commercialising an exciting and cutting-edge discovery in drug development. Our product is a novel diagnostic platform, combining a retinal biomarker with an AI algorithm to identify cellular level disease activity for the first time in humans. Our pioneering technology predicts disease progression and measures the impact of current and future therapeutics in glaucoma and Age-related Macular Degeneration (AMD). Following the analysis and further research of, we believe our product may also be successful in identifying a number of neurodegenerative diseases including; Alzheimer’s Disease, Parkinson’s Disease and Multiple Sclerosis.
The Role
The Clinical Trial Director will be responsible for all aspects of clinical development planning and strategy, clinical study planning and execution within pre-specified clinical development program, timelines and budget and includes, but is not limited to, preparation of study related materials, relationship management between study sites and vendors (in particular CROs), supervision of study related activities, identification of project risks and contingency planning.
Responsibilities:
• Lead and manage integration of all project team activities, leveraging internal and development partner resources, expertise and knowledge, along with optimising CRO resources, expertise and knowledge.
• Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for specified studies.
• Supporting BD function to engage new clients
• Manage a team but have overall responsibility for all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and the day-to-day operational management activities of operations
• Manage strategic study operations including: study sites and tracking systems for regulatory submissions, CRO KPIs, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, Pharmacovigilance/Serious Adverse Events, performance metrics, data flow, etc.
Essential Skills
• Clinical research experience gained with a CRO or Pharmaceutical Company working on international clinical studies required in AMD and glaucoma
• Demonstrated clinical project management experience with global clinical studies.
• Strong regulatory knowledge, including Good Clinical Practices (GCPs).
• Exceptional organisational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.
• Excellent communication (written and verbal) and presentation skills along with leadership qualities.
• Knowledge of global clinical trial management in fast paced CRO outsourced environment. Ability to assemble a plan and execute on the details.
• Experience in novel clinical drug development.
• Experience with protocol, ICF, CRF, CSR development and review.
• Strong organizational skills and ability to deal with competing priorities.
• Extensive Opthalmology experience
Education
• MD with a specialization in Ophthalmology required.
• PhD preferred.