Ophthalmic Clinical Development Leader

Visa Hunt; United States; On-site; USD 247,000 - 275,000; Full time

Job summary

Ocular Therapeutix, Inc. in Bedford, MA seeks a Senior Director of Clinical Development to lead design, execution, and reporting of clinical studies for NDA readiness.

This role oversees protocol development, data collection, and regulatory submissions with extensive cross-functional collaboration across internal teams and external partners. The candidate will ensure high-quality documentation, meticulous safety reviews, and regulatory compliance while driving development plans and timelines.

Qualifications

• MD, PhD, DO, PharmD or RN degree required.
• Minimum 5 years of clinical development industry experience in biotech/biopharma.
• Strong analytical skills to interpret scientific literature and data.
• Demonstrated ability to lead cross-functional teams and external partners.
• Excellent written and verbal communication, with strong negotiation skills.
• Travel up to ~25% as needed.

Responsibilities

• Provide hands-on guidance for clinical research activities per GCP guidelines leading to NDA and post-approval.
• Create clinical documents including protocols, IBs, CSRs and regulatory submissions.
• Represent Clinical Development in early and late-phase cross-functional teams.
• Lead review of safety data and act as Medical Monitor for assigned studies.
• Prepare data summaries and presentations for DSMC and advisory boards.
• Collaborate with cross-functional teams to review and reconcile study data.
• Support development of clinical development plans and timelines.
• Serve as primary contact for study sites and study teams.

Skills

Clinical development

Regulatory submissions

Medical monitoring

Cross-functional leadership

GCP & FDA guidelines

Education

MD/PhD/DO/PharmD/RN degree

Tools

MS Office

Excel

PowerPoint

Job description

Ocular Therapeutix, Inc. in Bedford, MA seeks a Senior Director of Clinical Development to lead design, execution, and reporting of clinical studies for NDA readiness.

This role oversees protocol development, data collection, and regulatory submissions with extensive cross-functional collaboration across internal teams and external partners. The candidate will ensure high-quality documentation, meticulous safety reviews, and regulatory compliance while driving development plans and timelines.