Global Director, Surgical Ophthalmic Clinical Development

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

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Tuition reimbursement

Job summary

Bausch + Lomb, a leading eye health company, seeks a Director of Surgical Clinical Development in the United States. You will shape global clinical strategies for ophthalmic devices, from early feasibility to post-market studies, aligning with regulatory pathways and payer requirements.

You will lead cross-functional teams, author pivotal clinical documents, and cultivate relationships with investigators and regulators to accelerate access and approvals.

Qualifications

• Advanced degree (MD, OD, PhD, or equivalent) in a clinical or biomedical science discipline.
• 7+ years of industry experience in medical device clinical development, with focus on ophthalmic surgery.
• Proven track record of leading global clinical strategy and regulatory submissions for surgical devices.
• In-depth understanding of GCP, ISO 14155, and global regulatory frameworks for medical devices.
• Experience in designing and executing pivotal and post-market studies, including registries and real-world evidence.

Responsibilities

• Lead global clinical development strategy for surgical device programs from concept through post-market activities.
• Serve as the clinical voice on regulatory submissions across FDA, EU MDR/CE Mark, China NMPA and Japan PMDA pathways.
• Design and oversee clinical trials including feasibility, pivotal, and post-approval studies across markets.
• Set direction and ensure alignment of clinical research priorities with company objectives, delivering impactful evidence.
• Develop and author regulatory and clinical documents: clinical investigation plans, protocols, reports, and submissions.
• Partner cross-functionally with R&D, Regulatory, Quality, and Commercial to translate clinical insights into product development and go-to-market strategies.
• Cultivate relationships with KOLs and investigators to represent leadership in surgical ophthalmology.
• Collaborate with regulatory and quality teams to align strategy with evolving pathways and support global submissions.
• Lead or contribute to project strategy teams, ensuring cross-functional alignment and clear communication.
• Support market-expansion efforts with evidence-generation strategies for various markets.
• Oversee clinical due diligence and input into product acquisitions and licensing opportunities.
• Support vendor oversight, clinical operations planning, and study execution.
• Develop best practices, infrastructure, and SOPs for a harmonized clinical development organization.
• Manage budgets and resources.
• Ensure timely submission of clinical trial data to regulators.
• Identify and mitigate risks in clinical research activities.

Skills

Global clinical development leadership

Regulatory submissions

GCP ISO 14155 knowledge

Strategic thinking

Team leadership

Cross-functional collaboration

Stakeholder communication

Education

Advanced degree (MD, OD, PhD, or equivalent)

Job description

Bausch + Lomb, a leading eye health company, seeks a Director of Surgical Clinical Development in the United States. You will shape global clinical strategies for ophthalmic devices, from early feasibility to post-market studies, aligning with regulatory pathways and payer requirements.

You will lead cross-functional teams, author pivotal clinical documents, and cultivate relationships with investigators and regulators to accelerate access and approvals.