1. Purpose:Operates with high autonomy to lead the cross-functional project management, operational tracking, and vendor coordination of IND-enabling nonclinical programs to ensure timely milestone execution and regulatory readiness. Plans, communicates, and optimizes translational scientific study designs in partnership with the translational team.
2. Accountabilities- Leads problem-solving and operational planning for IND-enabling preclinical studies (including toxicology, pharmacokinetics, and in vivo efficacy) to deliver high-quality project workflows at pace.
- Leads translational scientific initiatives, including key outsourced CRO experimental designs and plans. Recommends scientific strategies an provides feedback across the translational study landscape.
- Manages operational vendor relations and serves as the primary project contact with external CROs to align complex in vivo testing timelines, contract deliverables, and program budgets with functional goals.
- Anticipates execution obstacles and coordinates cross-functional workstreams across multiple therapeutic areas to remove operational bottlenecks and streamline project velocity.
- Implements project management best practices, cross-team tracking tools, and comprehensive dashboards to provide visibility on timelines, key dependencies, and resource allocations.
- Coordinates with preclinical, clinical operations, and regulatory teams to ensure operational readiness for global filings and seamless handoffs during program transitions.
- Oversees the tracking and operational assembly of nonclinical regulatory documentation packages (such as IND Module 4 Nonclinical Study Reports) to maintain precise regulatory readiness timelines.
- Ensures all contracted nonclinical study execution frameworks strictly align with ICH and GLP standard operating guidelines to mitigate corporate compliance and data-integrity risks.
- Shapes communication updates for R&D leadership, presenting precise timeline updates, critical path risks, and resource constraints to build enterprise trust.
RequirementsRequired Knowledge and Experience- Demonstrated capability in driving complex project management frameworks and tracking nonclinical timelines within a biotech, pharma, or CRO matrix environment.
- Deep operational insight into tracking IND-enabling study execution timelines, specifically toxicology, pharmacokinetics (PK), and in vivo pharmacology workflows.
- Advanced working knowledge of GLP compliance milestones, ICH project guidelines, and nonclinical regulatory documentation timelines (such as IND Module 4 assembly).
- Proven competence in balancing operational execution tracking with cross-functional team scheduling, identifying critical paths, and maintaining data workflows.
- Experience resolving scheduling friction, managing operational budgets, and optimizing vendor performance milestones with external service providers and contract testing laboratories.
- Formal project management training or credentials (such as a PMP path) accompanied by advanced tool proficiency in industry-standard Project and Portfolio Management software.
Notice to Recruitment Agencies & Search Firms:HAYA Therapeutics operates a Preferred Supplier List (PSL) and manages all recruitment directly through our Human Resources team. We do not accept unsolicited resumes or speculative CVs from third-party agencies, search firms, or recruiters. Any unsolicited candidates or CVs submitted through non-approved channels, directly to HAYA employees, or without a fully executed recruitment agreement in place will be considered property of HAYA Therapeutics. HAYA Therapeutics will not pay any fee, liability, or finder's fee for candidates submitted under these circumstances.
