This company’s team is being expanded to develop an increasing portfolio of gene therapy medicines for cardiac disorders. Orginally a virtual company, they have just received significant investment to transition into a new state of the art lab facility.
The successful candidate will support multiple gene therapy projects, from early phases and the subsequent transition to clinical development. You will work closely with both internal groups and the Company’s designated Contract Development and Manufacturing Organization (CDMO). This position requires a highly motivated self-starter with a strong PM and technical background who can assimilate new information quickly.
- Support cross-functional teams in development of timelines, planning and executing on development of AAV gene therapy programs (RD, IND and Phase I/II).
- Develop cross-functional timelines and budgets for CMC, Non-Clinical, Clinical and Regulatory.
- Understand product development under GCP, SOPs, and Regulatory requirements
- Partner with Program Leaders to identify risks, mitigations and ensure timely problem solving and communication.
- Drive execution of all stages of a project with internal teams and external CMOs/CROs
- Facilitate communication within the project team to identify risks, mitigations and communicate as appropriate.
- Ensure cross-functional teams are properly prepared for internal meetings, communications to management and engagement with external partners.
- Utilize formal communication protocols and tools including dashboards, reports, weekly/monthly updates, and any other specific information as needed for internal use and for CMO/CRO engagement to help achieve company and operational goals.