Senior Pre-clinical Project Manager
Encoded Therapeutics, United States
Job Description
Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com.
We are recruiting a Senior Project Manager, Ramp;D Gene Therapy to join our team to support planning, budgeting, tracking and communication across functional groups for Encoded’s AAV gene therapy programs. This is a unique opportunity to work at the intersection of genomics and therapeutics and participate in the development of a diverse therapeutic pipeline driven by a transformative core technology.
The successful candidate will work closely with internal cross-functional groups and the Company’s designated Contract Manufacturing and Contract Research Organizations (CMO/CRO) when needed. This position requires a highly motivated self-starter with a strong Project Management and Ramp;D background who can assimilate new information quickly. This individual will report to the Head of Program Management and will utilize established PM tools and help further identify tools and processes needed to support successful development and delivery of Encoded research and development programs.
Responsibilities:
- Support cross-functional teams in development of timelines, planning and executing on development of AAV gene therapy programs (IND through Phase I/II/III and launch).
- Develop cross-functional timelines and budgets for CMC, Non-Clinical, Clinical and Regulatory.
- Partner with Project Team Lead to support management and execution to timelines, prepare communication dashboards or other communication materials as defined.
- Partner with the Project Team Lead to identify risks, mitigations and ensure timely problem solving and communication.
- Partner with PM organization to establish and/or refine standard project management processes, systems, and tools.
- Drive execution of all stages of a project with internal teams and external CMOs/CROs in partnership with the Project Team Lead.
- Understand product development under GCP, SOPs, and Regulatory requirements
- Partner with Project Team Lead to 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 minutes, dashboards, progress 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.
- Drive risk management including conducting cross-functional or functional team level program risk assessments and scenario planning to understand impact and sensitivity of issues and plans.
- Partner with Project Team Lead to proactively drive the development of contingency and/or risk mitigation plans.
- Facilitate communication within the project team to identify risks, mitigations and communicate as appropriate via minutes, dashboards or other communication methods as appropriate.
Requirements
- Bachelor’s degree in Science or Engineering and 9 or more years of hands-on client-facing project management experience and training in biotechnology/pharmaceutical industries.
- 5 or more years experience with CMC, Clinical, Regulatory and pre-Clinical development.
- Highly motivated self-starter
- Strong Project Management and Ramp;D background who can assimilate new information quickly.
- Excellent communication, team management and conflict resolution skills.
- Excellent written and oral communication skills both internal and external.
- Understanding of pre-clinical amp; clinical development and understanding of regulatory requirements.
- Strong analytical and problem-solving skills coupled with the ability to work both independently and in a team environment.
- Ability to multi-task in a fast-paced environment.
- Attention to details and concern for standards.
- Strong time management and organizational skills.
- Identify and mitigate potential project risks with the team and develop mitigation strategies.
- Communicate program status, progress, risks including elevation of issues as needed, to key internal and external stakeholders.
- Ability to resolve conflict within project teams and know when to escalate if needed.
- Proficient utilizing MS Office Suite, specifically MS Project, SmartSheets, PowerPoint, etc.
Preferred Qualifications:
- Master's degree in Science or Engineering and 7 or more years of hands-on client-facing project management experie