Scott Duncan

Skills

Drug Development Strategy & Execution Cross-Functional Program Leadership
CMC Strategy & Operational Oversight CDMO - Vendor Management
CDMO – Vendor Selection and Due Diligence Compliance – Audit Management
Regulatory Compliance (FDA, EU, OUS) Regulatory Submissions (IND, NDA, IMPD)
Portfolio & Resource Management Governance & Stakeholder Communication
GxP (GMP, GLP, GDP) Compliance Risk & Scenario Management
Strategic Planning & Execution Budget & Resource Planning
Late-Stage Program Management Clinical-Commercial Transition Planning
Regulatory Strategy (IND, NDA, IMPD) AI Tool Implementation
Project Management Tools (MS Project, Smartsheet, Planisware)

About

Strategic, collaborative pharmaceutical executive with 30 years of experience driving late-stage development programs from strategy to execution. Demonstrated success aligning CMC, clinical, regulatory, and operational teams to achieve key milestones and transition assets to commercialization.

Recognized and trusted by senior stakeholders to drive clarity, decision-making, executive-level communication, matrix leadership, and the ability to execute complex development strategies in fast-paced, high-stakes environments.

Proven ability to lead cross-functional Product Development Teams (PDTs), drive operational efficiency, and implement performance monitoring tools to ensure programs are delivered on time, on budget, and with regulatory success.

Adept at inspiring diverse teams, navigating organizational complexity, and communicating critical path decisions to senior leadership.

Effective communicator and program leader with a strong record of delivering integrated asset plans, managing risk, aligning budgets, and guiding cross-functional teams to successful regulatory filings and commercial milestones.