Senior Director, Clinical Operations

Bayside Solutions; California; Hybrid; USD 180,000 - 280,000; Full time

Job summary

Bayside Solutions in Redwood City, CA, is seeking a Senior Director, Clinical Operations to lead strategy and execution across global programs from early-phase to registrational studies.

The role builds and guides a team of study leads and trial managers, sets outsourcing and vendor strategies, and partners with Clinical Development, Regulatory, Biometrics, and Finance to deliver programs on time, on budget, and inspection-ready.

Qualifications

• 12+ years in clinical operations, including sponsor experience.
• 5+ years leading global studies with multiple concurrent studies.
• 4+ years people management, including study leads.
• Experience setting outsourcing strategy and CRO contraction/governance.
• Rare disease trial experience in oncology, ophthalmology or immunology.
• Experience supporting FDA or EMA inspections.

Responsibilities

• Own operational strategy and delivery for multiple global studies or programs.
• Build, lead, and develop a team of Study Leads, CTMs, CRAs, and CTAs.
• Set outsourcing strategy, lead CRO and vendor selection, and govern relationships.
• Provide operational input into development plans, protocol design, feasibility.
• Drive ICH/GCP compliance and inspection readiness across the portfolio.
• Identify and mitigate portfolio risks; present program status to executives.
• Develop and improve SOPs and processes as the organization scales.

Skills

Clinical operations

Global program management

Team leadership

Vendor management

Outsourcing strategy

Regulatory inspections

Job description

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