临床开发主任（美国-远程，美国）

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
Objectives:
The Director, Surgical Clinical Development will serve as a strategic and scientific leader for global clinical development activities supporting Bausch + Lomb’s surgical device portfolio. This role will focus on the design and execution of clinical strategies for innovative ophthalmic devices, including intraocular lenses (IOLs), inserters, excimer and femtosecond lasers, and phacoemulsification systems. The role will be accountable for the development and delivery of clinical evidence to support global regulatory submissions.
This leader will drive clinical strategy from early feasibility through pivotal and post-market studies, helping to shape global product launch readiness while identifying innovative, efficient pathways to expand access and accelerate approvals. This role reports to the Vice President of Clinical Evidence Generation and will play a key role in cross-functional project leadership and external engagement with regulators, investigators, and partners. Excellent communication skills are necessary to influence both internal and external stakeholders.
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.

Requirements:

• 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.

• Established relationships with investigators, KOLs, and global regulatory experts in surgical ophthalmology is highly desirable.

This position may be available in the following location(s): US - Remote
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
For U.S. locations that require disclosure of compensation, the starting pay for this role is between $165,000 and $215,000. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.
U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please read Bausch + Lomb's Job Offer Fraud Statement.
Our Benefit Programs: Employee Benefits: Bausch + Lomb
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Originally posted on Himalayas