This critical role will provide clinical and scientific leadership to advance the clinical development programme. The role will report in to the Chief Development Officer.
The successful candidate must thrive working in a fast-paced, innovative environment while remaining flexible, resourceful and efficient. The ability to analyse complex issues developing relevant and realistic plans, programmes and recommendations are critical to success. The role will be a fundamental addition to the management team bringing significant innovative drug development experience to COMPASS Pathways.
Responsibilities and Duties:
- Responsible for design, implementation, performance, risk management and issue resolution in clinical development programmes
- Involved in collaborative efforts between clinical trial sites and Clinical Operations to ensure the high-quality execution of all clinical trials in compliance with regulatory requirements
- Works closely with the Regulatory Affairs, FDA, EMA and country-specific competent authorities to define the right regulatory pathway for each development programme
- Provides clinical & scientific leadership for trial concept generation, clinical trial protocols and related documents
- Functions as the medically qualified representative of the company, interfacing with the Board, Investors, Key Opinion Leaders, Investigators, Payors, Patient Groups, Health Authorities and the Media
- Works closely with cross-functional teams to identify, develop and implement novel technologies to support patient outcomes
- Participating in the creation of organisational strategy, goals, and objectives for the clinical research function and aids in implementation of the business plans to support both local and global clinical development strategies
- Responsible for the oversight and development of reports submitted to regulatory authorities
- Develops and maintains relationships with investigators and leading experts in the field of mental health research, psychiatry and neuroscience
- Participates in the development of the content of the Investigator’s Brochure and Clinical Development Plan; giving input into the value and safety of investigator-initiated trial proposals
- Maintains awareness of new and emerging safety concerns; participating in the safety surveillance committee to ensure that the safety information on COMPASS products is accurate and up to date
|Job Category||Biotech, Pharmaceuticals|