[Hiring] Vice President, Clinical Operations @Osanni

Role Description

The Vice President, Clinical Operations is responsible for building and leading the Clinical Operations function at MiraVi, Osanni's ophthalmology affiliate company, and for the end-to-end execution of its global clinical trials in our programs. Reporting to the Chief Medical Officer, this leader will set clinical operations strategy, build the team, CRO and vendor network, and processes needed to move programs from early clinical studies into late-stage development.

• Lead the Clinical Operations function for MiraVi, serving as a key member of the clinical leadership team.
• Own the end-to-end execution of clinical trials from study startup through database lock and close-out.
• Build and scale the Clinical Operations organization, including hiring, developing, and mentoring a high-performing team.
• Develop and execute global clinical operations strategy for MiraVi’s programs, including Phase 2 and pivotal studies.
• Partner with the Chief Medical Officer and Clinical Development on protocol design, feasibility, and study planning.
• Own CRO and vendor strategy, including selection, contracting, oversight, and performance management.
• Drive site selection, activation, and enrollment strategy, building strong relationships with KOLs and key investigators.
• Collaborate with Osanni’s Regulatory Affairs on IND, CTA, and health authority submissions.
• Partner with Osanni’s CMC and Supply Chain to manage clinical drug supply, packaging, labeling, and distribution.
• Work with Quality to ensure compliance with ICH GCP, FDA, EMA, and local regulations.
• Collaborate with Biostatistics and Data Management to ensure high-quality data collection and database lock.
• Own clinical trial budgets, forecasts, and timelines in partnership with Osanni’s Finance.
• Establish scalable clinical operations processes, SOPs, systems, and metrics.
• Manage multiple priorities in a fast-paced, evolving environment.

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.
• Ophthalmology or retina clinical trial experience strongly preferred.
• Deep expertise in CRO and vendor selection, contracting, and oversight.
• Thorough working knowledge of ICH GCP, FDA, EMA, and other global regulatory requirements.
• Strong financial acumen, with experience building and managing multi-million dollar clinical trial budgets.
• Experience building clinical operations functions, teams, and processes in a venture-backed or early-stage biotech environment.
• Excellent leadership, communication, and stakeholder management skills.
• Collaborative, adaptable, and hands-on working style.
• Willingness to travel domestically and internationally as needed (approximately 20 to 25%).

Requirements

• Experience supporting an NDA, BLA, or MAA submission strongly preferred.
• Familiarity with intravitreal therapies, ocular imaging endpoints, and central reading centers.
• Hands-on experience preparing for and supporting health authority inspections.

Benefits

• Base Pay: $330,000 — $350,000 USD.
• Comprehensive benefits package.

Company Description

MiraVi is part of Osanni’s ecosystem of affiliate companies, focused on advancing programs for dry age-related macular degeneration (AMD). We hold patients and the physicians who care for them as our North Star, guiding our purpose and defining our impact.