Director, Nonclinical Outsourcing & Ops Leader

GONDOLABIO SERVICECO INC; Palo Alto (CA); Ibrido; USD 215.000 - 240.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible PTO

Competitive compensation & benefits

Hybrid work model

Descrizione del lavoro

GondolaBio ServiceCo in Palo Alto seeks a Director, Nonclinical Operations to own outsourcing strategy and vendor management for GLP and non-GLP studies from discovery through IND/CTA and into late-stage development.

You will build and manage CRO networks, lead sourcing, contracting and vendor oversight, and collaborate with Toxicology to ensure timely, compliant study delivery and budget alignment.

Competenze

• Experience building CRO networks across nonclinical toxicology, pharmacology, safety pharmacology and pathology.
• Ability to manage RFIs/RFPs, capability/capacity assessments and vendor proposals.
• Strong knowledge of GLP (21 CFR Part 58) and OECD guidelines.
• Budgeting, forecasting, accruals and variance reporting with Finance.
• Cross-functional collaboration with Legal, QA and Procurement.

Mansioni

• Define and execute the nonclinical outsourcing strategy and vendor engagement.
• Lead end-to-end sourcing, including NDAs, CDAs, MSAs and work orders.
• Monitor study progress, set KPIs, and manage governance with CROs.
• Own the outsourcing budget and ensure on-time, on-budget delivery.
• Coordinate study management and regulatory submissions support.

Conoscenze

Outsourcing strategy

CRO selection

Vendor management

Budget forecasting

Contract negotiation

Regulatory compliance

Leadership

Descrizione del lavoro

GondolaBio ServiceCo in Palo Alto seeks a Director, Nonclinical Operations to own outsourcing strategy and vendor management for GLP and non-GLP studies from discovery through IND/CTA and into late-stage development.

You will build and manage CRO networks, lead sourcing, contracting and vendor oversight, and collaborate with Toxicology to ensure timely, compliant study delivery and budget alignment.