Senior Director, Clinical Operations

Location
Redwood City, CA - Hybrid Role

Job Summary
We're looking for a Senior Director, Clinical Operations to lead clinical operations strategy and execution across a portfolio of complex global clinical programs, from first-in-human through registrational studies. The candidate will build and lead a team of study leads and clinical trial managers, set the outsourcing and vendor strategy, and partner with Clinical Development, Regulatory, Biometrics, and Finance leadership to deliver programs on time, on budget, and inspection-ready. This is a key member of the Operations leadership team.

Duties and Responsibilities

Own operational strategy and delivery for multiple global studies or programs, including integrated timelines, portfolio-level budgets and forecasting, and quality metrics

Build, lead, and develop a team of Clinical Study Leads, CTMs, CRAs, and CTAs, with direct and indirect reports, including hiring, performance management, and succession planning.

Set outsourcing strategy, lead CRO and vendor selection, negotiate master and work-order agreements, and govern key vendor relationships through executive-level oversight.

Provide operational input into clinical development plans, protocol design, and feasibility, ensuring studies are designed for efficient execution.

Drive ICH/GCP compliance and inspection readiness across the portfolio, and serve as an operational lead during regulatory inspections and audits.

Identify and mitigate portfolio-level risks, escalat'e appropriately, and present program status to executive leadership.

Develop and improve clinical operations SOPs, processes, systems, and best practices as the organization scales.

Requirements and Qualifications

12+ years in clinical operations, including 6+ years at a sponsor company

5+ years leading global studies, with oversight of multiple concurrent studies or a full clinical program

4+ years of people management, including managing study leads or CTMs

Proven track record setting outsourcing strategy and leading CRO selection, contracting, and governance

Rare disease trial experience in areas such as oncology, ophthalmology, or immunology

Experience spanning early-phase through late-phase trials; registrational study or NDA/BLA experience strongly preferred

Direct experience supporting FDA or EMA inspections

Desired Skills and Experience
Clinical operations strategy, global clinical program management, early-phase through registrational trials, portfolio planning, timelines and budgets, forecasting, quality metrics, team leadership and development, hiring and performance management, succession planning, outsourcing strategy, CRO and vendor selection, contract negotiation, vendor governance, clinical development planning, protocol design and feasibility, ICH/GCP compliance, inspection readiness, FDA/EMA inspection support, audit support, risk management, executive reporting, cross-functional collaboration, SOP and process improvement, clinical systems optimization, rare disease trials, oncology/ophthalmology/immunology experience, NDA/BLA experience preferred, 12+ years in clinical operations, 6+ years sponsor experience, 5+ years global study leadership, 4+ years people management

J-18808-Ljbffr