Note: The job is a remote job and is open to candidates in USA. Bausch + Lomb is a global eye health company dedicated to protecting and enhancing vision through ophthalmic products and solutions. The Director, Surgical Clinical Development will lead global clinical strategy and evidence generation for surgical ophthalmic devices, overseeing trials, regulatory submissions, cross-functional partnerships, and post-market activities.
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 + Lomb’s 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
- 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 a strong focus on ophthalmic surgery
- Proven track record of leading global clinical strategy and successful regulatory submissions for surgical devices
- In-depth understanding of Good Clinical Practice (GCP), ISO 14155, and global regulatory frameworks specific to medical devices
- Experience in designing and executing both pivotal and post-market studies, including registries and real-world evidence strategies
- Strategic thinker with demonstrated ability to innovate around market access and evidence generation; label expansion a plus
- Strong leadership, project management, and team collaboration skills across matrixed global organizations
- Effective communicator with the ability to represent clinical and scientific perspectives clearly to internal and external stakeholders
- This position may be available in the following location(s): US - Remote
- Applicants must be authorized to work for ANY employer in the U.S
- Established relationships with investigators, KOLs, and global regulatory experts in surgical ophthalmology is highly desirable
Benefits
- U.S. based employees may be eligible for short-term and/or long-term incentives.
- Medical, dental, vision insurance, disability and life insurance
- A 401(k) plan and company match
- A tuition reimbursement program (select degrees)
- Company holidays
- Well-being benefits
- Sick time
- Floating holidays
- Paid vacation
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