Senior Manager, Preclinical Project Management & Translational Science

Haya Therapeutics SA; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

HAYA Therapeutics in San Diego is seeking an autonomous, cross-functional Project Manager to lead IND-enabling nonclinical programs, coordinate timelines, and manage vendor relationships.

You will design translational study plans with the translational team, ensure GLP and ICH compliance, and provide timely updates to R&D leadership. This role requires PMP or similar credentials and deep experience in toxicology, PK, and in vivo pharmacology.

Qualifications

• Demonstrated capability in driving complex project management frameworks for nonclinical programs.
• Experience coordinating IND-enabling studies including toxicology, PK, and in vivo pharmacology.
• Strong knowledge of GLP milestones, ICH guidelines, and nonclinical regulatory timelines.
• Ability to balance execution tracking with cross-functional scheduling and data workflows.
• Experience resolving scheduling friction and managing vendor performance milestones.
• Formal project management training or PMP credentials are required.

Responsibilities

• Lead cross-functional project management, tracking timelines, and vendor coordination for IND-enabling nonclinical programs.
• Plan and optimize translational study designs in partnership with the translational team.
• Coordinate external CROs and ensure contract deliverables align with program budgets and goals.
• Identify bottlenecks and coordinate multi-team workstreams to accelerate progress.
• Implement dashboards and tools to monitor timelines, dependencies, and resources.
• Collaborate with preclinical, clinical operations, and regulatory teams for global readiness.
• Assemble nonclinical regulatory documentation packages to maintain readiness timelines.
• Ensure all study execution frameworks align with ICH and GLP guidelines.
• Provide clear, timely updates to R&D leadership on critical path risks.

Skills

Project management

IND-enabling studies

GLP compliance

Vendor management

Cross-functional coordination

PMP or credentials

Education

PMP certification (or equivalent)

Tools

MS Project

Portfolio management tools

Job 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.

Requirements

Required 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.

HAYA Therapeutics is an Equal Opportunity Employer committed to fostering a diverse, inclusive, and equitable workplace where all individuals feel valued and empowered. We provide equal employment opportunities to all qualified applicants and employees without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, or gender expression), national origin, ancestry, age, marital or familial status, veteran status, disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

We prohibit discrimination and harassment of any kind and are committed to ensuring fair and equitable treatment in all aspects of recruitment, hiring, promotion, compensation, benefits, training, and career development.

At HAYA, we believe that diversity of thought, experience, and background drives innovation and strengthens our mission to transform patient care through cutting-edge RNA-based therapeutics.