VP, Global Clinical Operations — Ophthalmology (Remote)

Osanni; United States; Remote; USD 330,000 - 350,000; Full time

Job summary

MiraVi, part of Osanni’s ecosystem, is seeking a seasoned Vice President of Clinical Operations to lead end-to-end global clinical trials in ophthalmology. You will build a high-performing team, set a scalable strategy across US and international sites, and partner with Regulatory, CMC, and Finance to deliver trials on time and on budget.

The ideal candidate brings 15+ years in biotech/pharma clinical operations, with strong CRO/vendor oversight, global trial experience, and a track record in

Qualifications

• Bachelor's degree in life sciences, nursing, or a related field required; advanced degree preferred.
• 15+ years of clinical operations experience in biotech or pharma, including at least 5 years in a senior leadership role.
• Proven track record leading global Phase 2 and Phase 3 trials from startup through close-out; NDA/BLA/MAA submission experience preferred.
• Ophthalmology or retina clinical trial experience strongly preferred, including familiarity with intravitreal therapies and central reading centers.
• Deep CRO and vendor selection, contracting, and oversight expertise.
• Strong working knowledge of ICH GCP and global regulatory requirements with inspection readiness experience.
• Experience managing multi-million dollar clinical trial budgets and forecasts.
• Experience building clinical operations functions, teams, and processes in venture-backed environments.
• Excellent leadership, communication, and stakeholder management skills.
• Willingness to travel domestically and internationally (20–25%).

Responsibilities

• Lead the Clinical Operations function for MiraVi, owning end-to-end execution of clinical trials from startup to close-out.
• Build and scale the Clinical Operations organization, hiring and mentoring a high-performing team.
• Develop and execute global clinical operations strategy for Phase 2 and pivotal studies across US and ex-US geographies.
• Collaborate with Clinical Development on protocol design, feasibility, and study planning for operational feasibility.
• Own CRO and vendor strategy, including selection, contracting, oversight, and performance management.
• Drive site selection, activation, and enrollment strategy; build relationships with investigators and leading sites.
• Coordinate with Regulatory Affairs on IND/CTA submissions and regulatory readiness.
• Coordinate with CMC and Supply Chain to plan drug supply, packaging, labeling, and distribution.
• Ensure trial compliance with ICH GCP, FDA/EMA and local regs, and maintain Trial Master File readiness.
• Collaborate with Biostatistics/Data Management to ensure data quality and timely DB lock.
• Own budgets, forecasts, and timelines; report progress, risks, and mitigations to CMO, executives, and Board.
• Establish scalable SOPs and processes to support growth from early to late-stage development.
• Manage multiple priorities in a fast-paced environment and perform related duties.

Skills

People leadership

Global trial management

Budget management

Regulatory knowledge

Vendor management

Strategic planning

Site activation

KOL relationship building

Cross-functional collaboration

Education

MS/PhD preferred

Tools

CTMS

Regulatory submission tools

Job description

MiraVi, part of Osanni’s ecosystem, is seeking a seasoned Vice President of Clinical Operations to lead end-to-end global clinical trials in ophthalmology. You will build a high-performing team, set a scalable strategy across US and international sites, and partner with Regulatory, CMC, and Finance to deliver trials on time and on budget.

The ideal candidate brings 15+ years in biotech/pharma clinical operations, with strong CRO/vendor oversight, global trial experience, and a track record in