Vice President, Clinical Operations

Osanni; United States; À distance; USD 330 000 - 350 000; Plein temps

Résumé du poste

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%).

Responsabilités

• 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.

Connaissances

People leadership

Global trial management

Budget management

Regulatory knowledge

Vendor management

Strategic planning

Site activation

KOL relationship building

Cross-functional collaboration

Formation

MS/PhD preferred

Outils

CTMS

Regulatory submission tools

Description du poste

MiraVi is part of Osanni’s ecosystem of affiliate companies, called “Avians,” and is focused on advancing programs for dry age-related macular degeneration (AMD). At MiraVi, we combine the focus and agility of a dedicated company with Osanni’s scientific expertise and operational support to develop new medicines for patients.

We hold patients and the physicians who care for them as our North Star. It guides our purpose, sharpens our decision-making, and defines our impact. We are building a highly skilled team, passionate about having an impact on human health.

About the Role:

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, and will work closely with Clinical Development, and Osanni’s Regulatory, CMC, Quality, and Finance to deliver high-quality studies on time and on budget.

The ideal candidate is a seasoned, hands-on clinical operations leader who is just as comfortable setting strategy with executive leadership as working through site activation and enrollment details with the study team. They bring sound judgment, operational discipline, and a strong sense of ownership; they move quickly and adapt as plans change. A collaborative, transparent leader who builds trust with investigators, vendors, and colleagues alike, they will help create a connected, high-performing team.

What You Will Do:

• Lead the Clinical Operations function for MiraVi, serving as a key member of the clinical leadership team reporting to the Chief Medical Officer and owning 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 of clinical trial managers and clinical operations professionals as the pipeline advances.
• Develop and execute global clinical operations strategy for MiraVi’s programs, including Phase 2 and pivotal studies across US and ex-US geographies.
• Partner with the Chief Medical Officer and Clinical Development on protocol design, feasibility, and study planning, ensuring trial designs are operationally achievable and aligned with program objectives.
• Own CRO and vendor strategy, including selection, contracting, oversight, and performance management of CROs, central reading centers, imaging vendors, labs, IRT, and other clinical service providers.
• Drive site selection, activation, and enrollment strategy, building strong relationships with KOLs, key investigators, and leading clinical sites.
• Collaborate with Osanni’s Regulatory Affairs on IND, CTA, and health authority submissions, ensuring clinical documentation and operational plans support regulatory strategy and inspection readiness.
• Partner with Osanni’s CMC and Supply Chain to plan and manage clinical drug supply, packaging, labeling, and distribution to sites.
• Work with Quality to ensure all studies are run in compliance with ICH GCP, FDA, EMA, and local regulations, maintaining audit and inspection readiness and overseeing the Trial Master File.
• Collaborate with Biostatistics and Data Management to ensure high-quality, timely data collection, cleaning, and database lock.
• Own clinical trial budgets, forecasts, and timelines in partnership with Osanni’s Finance, providing clear reporting on study progress, risks, and mitigations to the CMO, executive leadership, and the Board.
• Establish scalable clinical operations processes, SOPs, systems, and metrics that support MiraVi's growth from early clinical to late-stage development.
• Manage multiple priorities in a fast-paced, evolving environment, ensuring deliverables are completed accurately and on time, while performing other related duties as required.

What You Bring:

• Bachelor's degree in life sciences, nursing, or a related field required; advanced degree (MS, MPH, PhD, PharmD, RN, MD or MBA) preferred.
• 15+ years of clinical operations experience in biotech or pharma, including at least 5 years in a senior leadership role managing clinical operations teams.
• Proven track record leading global Phase 2 and Phase 3 trials from startup through close-out; experience supporting an NDA, BLA, or MAA submission strongly preferred.
• Ophthalmology or retina clinical trial experience strongly preferred, including familiarity with intravitreal therapies, ocular imaging endpoints, and central reading centers.
• Deep expertise in CRO and vendor selection, contracting, and oversight, including outsourced and hybrid operating models.
• Thorough working knowledge of ICH GCP, FDA, EMA, and other global regulatory requirements, with hands‑on experience preparing for and supporting health authority inspections.
• Strong financial acumen, with experience building and managing multi‑million dollar clinical trial budgets and forecasts.
• Experience building clinical operations functions, teams, and processes in a venture‑backed or early‑stage biotech environment.
• Excellent leadership, communication, and stakeholder management skills, with the ability to present clearly to executive leadership and the Board.
• Collaborative, adaptable, and hands‑on working style; comfortable with ambiguity and able to balance strategic thinking with attention to detail.
• Willingness to travel domestically and internationally as needed (approximately 20 to 25%).

#LI-remote

Below is the expected base pay range for this position plus bonus and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training.

Base Pay

$330,000 - $350,000 USD

We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

We will provide an intellectually stimulating, collegial and fast-paced environment. If you are ready to be a part of building the future of transformative medicines, then we are excited to hear from you!