Director, Clinical Development

Scorpion Therapeutics; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks a Director of Surgical Clinical Development to lead global strategies for ophthalmic surgical devices, including IOLs, lasers, and phacoemulsification systems.

You will oversee clinical trial design, regulatory documentation, and alignment with FDA/EU MDR/NMPA/PMDA, collaborating with R&D, Regulatory, Quality, and Commercial teams to drive evidence generation and market expansion.

Qualifications

• Advanced degree (MD, OD, or PhD) in a relevant field.
• 7+ years in medical device clinical development, especially ophthalmology.
• Proven leadership in global regulatory submissions.
• Deep knowledge of GCP, ISO 14155, and international regulatory frameworks.
• Experience with pivotal and post-market studies, registries, and real-world evidence strategies.
• Strong leadership, communication, and cross-functional collaboration skills.

Responsibilities

• oversee clinical trial design and execution from early feasibility to post-market studies
• develop and author regulatory and clinical documentation
• ensure alignment with global regulatory agencies (FDA, EU MDR, NMPA, PMDA)
• collaborate with R&D, Regulatory, Quality, and Commercial teams
• manage relationships with KOLs and external stakeholders
• support regulatory submissions and market-expansion efforts
• oversee study operations, budgets, and risk mitigation

Skills

Leadership

Cross-functional collaboration

Regulatory strategy

Ophthalmology domain knowledge

Education

MD/OD/PhD

Job description

Role:

Director of Surgical Clinical Development leading global strategies for ophthalmic surgical devices, including IOLs, lasers, and phacoemulsification systems.

Responsibilities:

• oversee clinical trial design and execution from early feasibility to post-market studies


• develop and author regulatory and clinical documentation


• ensure alignment with global regulatory agencies (FDA, EU MDR, NMPA, PMDA)


• collaborate with R&D, Regulatory, Quality, and Commercial teams


• manage relationships with KOLs and external stakeholders


• support regulatory submissions and market-expansion efforts


• oversee study operations, budgets, and risk mitigation

Requirements:

• advanced degree (MD, OD, PhD)


• 7+ years in medical device clinical development, especially ophthalmology


• proven leadership in global regulatory submissions


• deep knowledge of GCP, ISO 14155, and international regulatory frameworks


• experience with pivotal and post-market studies, registries, and real-world evidence strategies


• strong leadership, communication, and cross-functional collaboration skills

HighValue:

• ophthalmic surgical devices


• global regulatory strategy


• clinical evidence generation


• early feasibility through post-market


• remote work with US-based location