This is a hands-on position, reporting directly to the CMO, and will be responsible for the oversight, management and delivery of clinical trials. This includes execution of clinical development plans, managing clinical staff, managing clinical outsourcing and overseeing financial and budgetary aspects of all clinical trials. It is also expected that the person in this role will be comfortable wearing multiple hats as the company builds its clinical team.
What You Will Be Primarily Responsible For:
- Provide a leadership role in conducting multiple Phase I-IV clinical research trials across all functional areas of the drug development process
- Oversee and coordinate the operational aspects of ongoing projects
- Lead the selection and negotiation activities related to CROs, vendors and investigator sites as it relates to contracts, work orders and budgets.
- Review budgets, forecasts and accruals for clinical studies, and ensure that clinical projects remain on schedule and within budget
- Report on study progress, timelines, milestones and challenges
- Attend investigator meetings, kick-off meetings and various CRO or other vendor meetings
- Liaise with Regulatory Affairs and Quality to assure adherence to GCPs; maintenance of SOPs and assure site and CRO/vendor audits are completed
What We Are Looking For:
- Bachelor degree required; advanced degree preferred
- Minimum 8 years relevant industry experience in clinical/medical research or biotech/pharma
- Minimum 5 years leading Clinical Operations
- Ability to quickly learn and apply new skills, meet short deadlines and multi-task in a fast-moving environment
- Understand and experience in data management, statistics, project management and other disciplines necessary for successful study execution
- Experience in both small company and large company environments ideal
- Ability to travel up to 20% of the time, on average
To apply for a position, please send your CV to FindYourCareer@ocugen.com.
No recruiters please.