Sr. Director Clinical Development
Sr. Director Clinical Development (Remote)
Compensation: $300,000-330,000 + bonus + equity
Company Summary:
This biopharma company is redefining treatment paradigms in ophthalmology. With an FDA-approved product already on the market and a robust pipeline spanning multiple Phase 1-2 programs plus preclinical assets in high-value indications, they are positioned as a leader in transforming care for chronic eye conditions.
Their proprietary technology enables long-acting therapies that reduce treatment burden and improve patient outcomes. The company is on track for double-digit revenue growth, driven by expanding adoption of its commercial product and upcoming regulatory milestones. Backed by an experienced leadership team with a proven track record of successful approvals and strategic partnerships, they offer a strong foundation for continued innovation and growth.
Position Summary
The Senior Director, Clinical Development will lead the design, execution, and reporting of clinical trials across Phases I-III, ensuring alignment with development strategy and regulatory standards. Responsibilities include protocol development, endpoint and eligibility criteria, patient selection, and preparation of documentation for NDA and other regulatory submissions. This role collaborates cross-functionally and externally, requiring strong leadership, communication, and organizational skills.
Key Responsibilities
- Oversee all clinical research activities per GCP, from early development through NDA and post-approval.
- Author and review clinical documents (protocols, IBs, CSRs, regulatory submissions, publications).
- Represent Clinical Development on cross-functional teams and in regulatory, advisory, and professional meetings.
- Serve as Medical Monitor; review safety data, protocol deviations, and prepare DSMC and advisory board presentations.
- Collaborate with clinical operations, data management, and other teams to ensure data integrity and issue resolution.
- Act as primary contact for study-related inquiries and support successful program execution.
- Perform additional clinical duties as needed.
Qualifications
- MD, PhD, DO, PharmD, 5+ years in clinical development (ophthalmology experience preferred).
- Expertise in FDA guidelines, GCP, and SOP compliance.
- Strong analytical, organizational, and communication skills; ability to lead multi-disciplinary teams.
- Experience developing protocols, IBs, study reports, and regulatory documents.
- Ability to thrive in a fast-paced environment, manage multiple priorities, and travel up to 25%.
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