Roles
This is the individual who must ensure delivery of the program on time and budget according to the Target Product Profile
What is the Vaccine Development Team Lead / VDTL
This key document captures what the final vaccine should achieve and is the foundation for strategic decision-making
What is Target Product Profile (TPP)
These teams execute work in support of discrete scope as set forth by subteam.
What are Working Groups
CDP
What is Clinical Development Plan
Ensures delivery of functional activities and leads respective Sub team
What is Functional Area Lead / FAL
Teams must continuously identify and address these uncertainties that could jeopardize program timelines or quality.
What are Risks
Is the Subteam decision-maker in case team consensus cannot be reached (Certain decisions must be made by responsible parties (e.g. clinical for patient safety issues; quality for ensuring compliance to rules and regulations)
Subteam Lead (VDT FAL)
FAL
What is Functional Area Lead
Empowered and accountable to support planning, decision making, and leading or overseeing work, these individuals have skills and experience to uphold this role and act on behalf of their function within the subteam.
What is Subject Matter Expert / SME
This term describes when teams proactively flag decisions that exceed their authority and must move upward for approval.
What is Escalation
These teams establish strategies and plans integrated across Working Groups, IDs and manages decisions, risks, opportunities, raising program risks and cross-program decisions to VDT
What are subteams
What is Executive Management Team
This leader is accountable for planning, strategy, and management of subteam.
What is the Subteam Lead - the respective VDT FAL
Each plan: clinical, nonclinical, CMC, and regulatory must align with this overarching roadmap that integrates all functions
What is Integrated Product Development Plan (IPDP)
Provides strategic direction, planning, and oversight of program
What is the Vaccine Development Team / VDT
IPDP
What is Integrated Product Development Plan
This is the team that ensures the R&D pipeline is delivering value to the organization
What is the Executive Management Team / EMT
There must be a continuum and bi-directional flow of this to ensure all individuals remain informed.
What is communication Communication
Ensures pipeline progression aligned with R&D stakeholders, organizational strategy and goals.
What is R&D LT
PI
What is Principal Investigator