Job Type
Full-time
Description
Director, Nonclinical Operations Location: (Palo Alto, CA/Hybrid)
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.
Essential Skills and Function-
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.
Requirements
Requirements Preferred Education and Experience - 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.
No matter your role at GondolaBio, successful team members are: - Patient Champions, who put patients first and uphold strict ethical standards
- Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
- Truth Seekers, who are detailed, rational, and humble problem solvers
- Individuals Who Inspire Excellence in themselves and those around them
- High-quality executors, who execute against goals and milestones with quality, precision, and speed
What We Offer - Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
- A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
- An unyielding commitment to always putting patients first.
- A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
- A place where you own the vision-both for your program and your own career path
- A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
- Access to learning and development resources to help you get in the best professional shape of your life
- 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
The base pay range for this position is $215,000 -$240,000 per year. The actual compensation offered will be determined based on a number of job-related factors, including experience, skills, qualifications, and location.
