Executive Director, Global Program Lead

Job description

Overview The Executive Director, Global Program Lead is responsible for leading the XP-8121 program through Phase 3 execution, regulatory approval, and a successful launch. The role is accountable for driving the cross-functional strategy and rigorous execution. It leads the XP-8121 project team, providing direction and oversight, with value maximization, compliance, and quality top of mind. The Program Lead should possess a strong commercial mentality to ensure that Clinical, CMC and Medical strategies deliver the target product profile and ultimate market access and adoption. This position may also support critical development activities as needed. Responsibilities: - Lead the cross-functional project team to deliver on-time and consistent with Xeris’ compliance and quality standards: o Clinical program, including the pivotal Phase 3 study o Product development to support clinical execution and pre-NDA regulatory filings o Product development to support NDA filing and scaling for commercial volumes o Regulatory submissions, including IND amendments and NDA filing and approval o Medical strategy o Medical execution, including real-world data generation, KOL development, publicatio...