Senior Manager, Preclinical Project Management & Translational Science
- Compensation
- Not disclosed
- Location
- San Diego, California, United States
- Work setup
- Not specified
- Seniority
- Senior
- Employment
- Contract
- Experience
- Not specified
- Category
- Not specified
- Posted
Must have
- 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.
Full description
At HAYA Therapeutics, we are revolutionizing RNA-guided genome-targeting therapies to treat fibrosis, heart failure, and other serious diseases associated with aging. Our innovative platform leverages long non-coding RNAs (lncRNAs)—key regulators within the “dark matter” of the genome—to develop first-in-class, highly specific therapies that modulate gene expression and restore cellular function.
Recognized for our innovation, HAYA received the prestigious Innosuisse Certificate for Sustainable Growth and has been nominated as TOP Innovative Companies in Switzerland 2025. As a fast-growing biotech, we offer an entrepreneurial, science-driven environment where you’ll have a direct impact on shaping our pipeline and advancing RNA medicine.
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.