Teams at Kailera Therapeutics, Inc.

Leads late-stage biopharmaceutical programs from Phase 3 through regulatory approval and launch readiness. Oversees development strategy, cross-functional alignment, governance, risk management, milestone execution, and integrated commercial preparation. Partners with R&D, Regulatory, CMC, medical, market access, and commercial teams while representing program leadership to executive and board-level stakeholders. Builds decision-making and planning systems and leads program teams in a fast-growing biotech environment.

Leads global regulatory strategy and submissions for investigational and future marketed products, including INDs, CTAs, NDAs, and MAAs. Coordinates cross-functional preparation, reviews applications for accuracy and compliance, monitors global regulations, provides regulatory intelligence, responds to agency questions, manages risk, and develops SOPs and work instructions. The role is hub-based in Waltham, Massachusetts, onsite three to four days weekly, with 10–15% travel.

Leads operational execution of Kailera’s clinical development portfolio, with primary responsibility for Phase 3 programs through NDA submission readiness. Builds integrated plans, governance, dashboards, risk-management processes, and cross-functional alignment across Clinical, Regulatory, CMC, Medical Affairs, Commercial, and Finance. Manages and develops Program Managers, supports late-stage development strategy, presents portfolio updates to senior leadership and boards, and establishes a scalable program management office emphasizing accountability, transparency, compliance, and operational excellence.