Keros Therapeutics Benefits Overview

Leads cross-functional clinical program teams and global clinical trial execution across planning, vendors, budgets, timelines, compliance, and quality. Oversees clinical operations resources, study feasibility, site and country selection, trial documentation, safety and data review planning, risk mitigation, inspection readiness, corrective actions, and process improvement. Requires extensive biotech, pharmaceutical, or CRO experience, global Phase 1–3 study expertise, people management, and familiarity with FDA, EMEA, GDPR, ICH, and GCP requirements.

Leads Keros’ financial planning and analysis function, including annual budgeting, quarterly forecasting, variance analysis, long-range financial planning, corporate modeling, cash runway assessment, and financial reporting. Partners with leadership and program teams to align operational goals with financial plans, recommend spending actions, support business development and financing analyses, develop KPIs, implement a corporate planning tool, and prepare materials for executives and the Board.

Directs regulatory operations for a biotech company, overseeing Veeva Vault RIM administration, health authority archives, submission management, training, reporting, SOPs, and system validation. Provides eCTD/CTD publishing and quality control for major submissions such as INDs and BLAs, coordinates internal regulatory functions and external vendors, and maintains submission templates and regulatory information management processes.