Senior Manager, Preclinical Project Management & Translational Science

HAYA Therapeutics is a biotech company focused on developing RNA-guided genome-targeting therapies to treat serious diseases like fibrosis and heart failure. The company uses long non-coding RNAs (lncRNAs) to create highly specific therapies that modulate gene expression and restore cellular function. The Senior Manager, Preclinical Project Management & Translational Science will lead cross-functional project management, operational tracking, and vendor coordination for IND-enabling nonclinical programs. This role ensures timely milestone execution and regulatory readiness, with a focus on planning, communicating, and optimizing translational scientific study designs. The main responsibilities include leading problem-solving and operational planning for preclinical studies, managing vendor relations, and coordinating with various teams to ensure operational readiness. The role involves implementing project management best practices, tracking nonclinical regulatory documentation, and ensuring compliance with ICH and GLP guidelines. The manager will also provide updates to R&D leadership, presenting timeline updates, critical path risks, and resource constraints. To excel in this role, candidates must have a demonstrated capability in driving complex project management frameworks and tracking nonclinical timelines within a biotech, pharma, or CRO environment. Deep operational insight into tracking IND-enabling study execution timelines, specifically in toxicology, pharmacokinetics, and in vivo pharmacology, is essential. Advanced knowledge of GLP compliance, ICH project guidelines, and nonclinical regulatory documentation timelines is required. Proven competence in balancing operational execution tracking with cross-functional team scheduling and maintaining data workflows is also necessary. Experience in resolving scheduling friction, managing operational budgets, and optimizing vendor performance milestones is crucial. Formal project management training or credentials, such as a PMP path, and proficiency in industry-standard Project and Portfolio Management software are must-haves. Nice-to-have skills include the ability to work in an entrepreneurial, science-driven environment. The location and team dynamics are not specified, but the role offers the opportunity to have a direct impact on shaping the company's pipeline and advancing RNA medicine. The company is committed to fostering a diverse, inclusive, and equitable workplace. What the role asks for: - Experience in leading complex project management frameworks and tracking non-clinical timelines in a Biotech-, Pharma- or CRO-matrix environment. - Deep operational insights into tracking IND-ready study execution timelines, particularly in Toxicology, Pharmacokinetics (PK) and in vivo Pharmacology. - Advanced knowledge in GLP-Compliance milestones, ICH project guidelines and non-clinical regulatory documentation timelines. - Proven competence in balancing operational execution tracking and cross-functional team planning, identifying critical paths and maintaining data workflows. - Experience in resolving scheduling conflicts, managing operational budgets and optimizing performance milestones with external service providers and contract test labs. - Formal project management training or certification, such as a PMP path, accompanied by advanced tool proficiency in industry-standard project and portfolio management software.