Regulatory Affairs Project Manager
Job Titles: Program Manager III / Regulatory Affairs Program Manager III Location: 100% Remote Duration: 6 months Payrate: $70/hr - $86/hr on W2 Job Summary:
- The Associate Director, Program Management plays an integral role in advancing gene therapy products through clinical development.
- They will provide comprehensive program management and operational support for the Integrated Product Team (IPT), including creation and maintenance of integrated, end-to-end development plans and timelines.
- This role partners with the IPT Lead to ensure the program team has clear direction and alignment to execute critical activities ranging from pre-clinical (IND-enabling) studies up through BLA submission (e.g., CMC, regulatory, clinical, medical).
Key Responsibilities:
- In partnership with the IPT Lead, define scope, objectives, and deliverables for product candidates in stages of clinical development
- Create and maintain integrated development plans that accurately capture timelines, decision points (i.e., stage gates), resource needs, and budget for multiple clinical programs
- Track and coordinate critical activities required to advance programs into early-stage and/or registrational clinical studies
- Provide general operational support to the IPT, including risk identification/mitigation, problem-solving, communication, and contingency planning
- In partnership with IPT lead, ensure the team is prepared for stage-gates and governance interactions, including content development, stakeholder management, and pre-reads
- Deliver timely updates to key functional stakeholders, leadership, and governance boards covering program status, risks/mitigation, scope changes, etc.
- Document IPT meeting minutes, key decisions, risks/issues, and action items
- Ensure the team communicates effectively and collaboratively, implementing team building techniques where needed to establish and maintain a high-performing teams
- Facilitate creation of program budgets, resource models and long-range plans
- Define resource needs (FTEs and financial) for each stage of development
- Ensure all critical program documentation is organized, accessible, and archived
- In partnership with the PM Center of Excellence, develop, implement, and champion PM best practices, processes, and strategies within the IPT and supporting functions
- Assist with implementation of stage-gates and IPT operating model, including education to the organizations through functional team sessions and meetings with stakeholders/teams
Required Education and Experience:
- Bachelor’s degree in a technical or life science discipline
- 5+ years of experience within the pharmaceutical/biotechnology industry
- 5+ years of project/program management experience
- Excellent written and verbal communication skills with the ability to communicate effectively across disciplines and experience levels, including executive management
- Experience in planning and/or managing cross-functional aspects of biopharmaceutical product development, including translational and clinical studies
- Experience with SmartSheets and/or other project planning/management software
- Ability to mentor, lead, and/or influence partners in a matrixed environment
- Previous exposure to budgeting and resource management processes
Preferred Experience and Skills
- Advanced degree (e.g., Master’s or Doctorate) in a technical or life science discipline
- Project Management Professional (PMP) or an equivalent certification
- Prior experience with developing advanced therapies (e.g., cell or gene therapy)
- Experience working on/with global teams
- Understands and interprets technical data related to biopharmaceutical product development