Global Director, Surgical Ophthalmic Clinical Development

Bausch + Lomb; Boise (ID); On-site; USD 165,000 - 215,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(K) match

Tuition reimbursement

Job summary

Bausch + Lomb is seeking a Director of Surgical Clinical Development to lead global strategies for ophthalmic devices, including IOLs, inserters, lasers, and phaco systems. You will shape evidence generation, support regulatory submissions, and collaborate across R&D, Regulatory, and Quality to ensure swift product launches.

The role requires an advanced degree and 7+ years in medical device clinical development, with strong leadership and communication skills to influence regulators,

Qualifications

• Advanced degree in a clinical or biomedical science discipline.
• 7+ years of industry experience in medical device clinical development.
• Leadership in global regulatory submissions for surgical devices.
• Knowledge of GCP, ISO 14155, and global regulatory frameworks.
• Experience in pivotal and post-market studies.

Responsibilities

• Lead global clinical development strategy for surgical device programs from early-stage concept through post-market activities.
• Serve as the clinical voice on global regulatory submissions, ensuring strategic alignment with FDA, EU MDR/CE Mark, China (NMPA), and Japan (PMDA) regulatory pathways.
• Design and oversee clinical trials including feasibility, pivotal, and post-approval studies across diverse markets.
• Set direction and ensure alignment of clinical research priorities with company objectives, ensuring timely delivery of impactful clinical evidence.
• Develop and author key regulatory and clinical documents including clinical investigation plans, study protocols, clinical reports, and submission dossiers.
• Partner cross-functionally with R&D, Regulatory, Quality, and Commercial to translate clinical insights into product development and go-to-market strategies.
• Cultivate and sustain high-impact relationships with Key Opinion Leaders (KOLs), investigators, and key external stakeholders to represent Bausch + Lombs leadership in surgical ophthalmology.
• Collaborate with global regulatory and quality teams to align clinical strategy with evolving regulatory pathways and support successful global submissions.
• Lead or contribute to project strategy teams and clinical sub teams, ensuring clear communication and alignment across functions.
• Support market-expansion efforts through novel evidence-generation strategies tailored to payer and regulatory requirements in emerging and established markets.
• Oversee clinical due diligence and provide input into product acquisitions and licensing opportunities.
• Support vendor oversight, clinical operations planning, and study execution.
• Contribute to the development of best practices, infrastructure, and SOPs to support a globally harmonized, agile, and compliant clinical development organization.
• Manage budgets and resources.
• Ensure timely submission of clinical trial data to regulatory authorities.
• Identify and mitigate risks associated with clinical research activities.

Skills

Regulatory submissions

GCP knowledge

ISO 14155

Clinical trials design

Leadership

Project management

KOL engagement

Communication

Education

MD/OD/PhD or equivalent

Job description

Bausch + Lomb is seeking a Director of Surgical Clinical Development to lead global strategies for ophthalmic devices, including IOLs, inserters, lasers, and phaco systems. You will shape evidence generation, support regulatory submissions, and collaborate across R&D, Regulatory, and Quality to ensure swift product launches.

The role requires an advanced degree and 7+ years in medical device clinical development, with strong leadership and communication skills to influence regulators,