Director, Nonclinical Operations

GondolaBio Service Co • Palo Alto, CA

1d • Hybrid

About The Position

GondolaBio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. GondolaBio is an independent sister company to BridgeBio, originally carved out in 2024 after securing $300M in private financing from external investors. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases.

Who You Are
The Director, Nonclinical Operations owns the outsourcing strategy and vendor management for GLP and non-GLP nonclinical safety studies, from Discovery through IND/CTA and into Late-Stage development. Reporting to the Executive Director, Toxicology, this role builds and manages our CRO and specialty vendor network, leads sourcing, contracting and vendor oversight. The Director, Nonclinical Operations will work in close collaboration with GondolaBio Toxicologists and may have matrixed oversight over consultant Study Monitors/Study Managers to ensure that outsourced studies are delivered on schedule, within budget and in compliance with applicable regulatory standards.

Requirements

• Bachelor's degree in toxicology, pharmacology, biology or a related life science; an advanced degree (MS, PhD, DVM) is preferred.
• 12+ years of pharmaceutical or biotechnology experience (10+ with an advanced degree), including 7+ years of study director experience, outsourcing and/or management of nonclinical safety studies.
• Deep knowledge of GLP regulations, relevant ICH guidelines and animal welfare requirements.
• Experience with designing and implementing standard and bespoke study designs (eg: integration of safety pharmacology endpoints in toxicology studies
• Demonstrated success leading RFPs, negotiating MSAs and work orders, and managing budgets.
• Established relationships across the nonclinical CRO landscape and a working knowledge of vendor capabilities, pricing and capacity.
• Experience with development of established platforms (small molecules, biologics) as well as novel modalities (eg: oligonucleotides) is desirable.

Responsibilities

• Outsourcing strategy and CRO selection: Build and maintain a preferred-provider network across nonclinical toxicology, secondary pharmacology, safety pharmacology and pathology disciplines. Define and execute the nonclinical outsourcing strategy, including selection and engagement of safety screening, pivotal studies and mechanistic follow-up providers. Lead end-to-end sourcing: RFIs/RFPs, capability and capacity assessments, proposal evaluation.
• Contracting and financial management: Partner with Legal and Procurement teams to negotiate NDAs, CDAs, MSAs, work orders and change orders. Benchmark CRO pricing and drive cost and time-effective contracting, including lead time, preferred sites, volume and multi-study agreements. Review and approve CRO invoices against contracted milestones; resolve discrepancies. Own the nonclinical outsourcing budget: forecasting, accruals and variance reporting with Finance.
• Vendor oversight and performance management: Monitor study progress across vendors, anticipating risks and driving issue resolution. Set clear expectations, KPIs and service levels for each vendor (timeliness, quality, report turnaround, budget adherence). Run regular governance meetings and quarterly business reviews with strategic CROs; escalate and resolve performance issues. Maintain a vendor risk register and contingency plans, including backup vendors. Track vendor performance data and use it to inform future sourcing decisions.
• Quality, compliance and regulatory support: Ensure vendors comply with GLP (21 CFR Part 58, OECD), animal welfare regulations (AAALAC, USDA, 3Rs) and our quality agreements. Partner with QA on audit findings and CRO CAPA follow-up. Deliver study reports and data packages for regulatory submissions (IND, CTA, IB, NDA/BLA, MAA) on schedule, and support responses to health authority questions.
• Leadership and cross-functional partnership: Matrixed oversight of an external team of nonclinical study managers and study monitors. Develop outsourcing SOPs, vendor oversight plans, templates and tools that scale with a growing portfolio. Represent Nonclinical Operations on affiliate programs.
• Study execution through vendors: As business needs require, this role may also assume nonclinical study monitoring, study management and toxicologist responsibilities such as: Sponsor oversight and study management of outsourced GLP and non-GLP studies from protocol through final report in collaboration with toxicologists and subject matter experts. Coordination of test article shipments, sample transfers between vendors, and data and report archiving with CMC and QA. In collaboration with a senior toxicologist, formulation of nonclinical safety testing strategies, interpretation and contextualization of study findings, contribution to regulatory submissions and health authority query responses.

Benefits

• Robust and market-competitive compensation & benefits package (Base Salary, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple GondolaBio programs across multiple therapeutic areas over time
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion

What This Job Offers

• Job Type: Full-time
• Career Level: Director