Note: The job is a remote job and is open to candidates in USA. Ollin Biosciences is a biotechnology company developing therapeutics for serious ophthalmic diseases, including neovascular age-related macular degeneration, diabetic macular edema, thyroid eye disease, and Graves’ disease. The Associate Director/Director, Clinical Scientist will help shape clinical development strategy, lead clinical trial planning and data review, author key regulatory documents, support pivotal study milestones, and communicate scientific findings to regulators, investors, and the scientific community.
Responsibilities
- Help shape clinical development strategy. Including endpoints, competitive differentiation, and scientific risk
- Partner across clinical operations, regulatory, and CRO/vendor teams to keep programs moving
- Build relationships with regulators, key opinion leaders, and industry partners
- Author and refine protocols, amendments, and key regulatory documents (IBs, ICFs, safety updates, submission dossiers)
- Lead high-quality clinical data review, spotting trends and insights that matter for patient safety and data integrity
- Guide data review strategy, CRF development, and adoption of innovative data capture and analysis tools
- Support pivotal study milestones, interim analyses, database lock, and beyond
- Champion GCP compliance and proactively manage trial risk
- Turn program data into abstracts, posters, and manuscripts
- Present to investors, regulators, and the scientific community
- Build collaborations with academic and research partners
- Contribute to INDs, NDAs, and BLAs, and support meetings with regulatory agencies
Skills
- PhD, PharmD, MD, or equivalent in Ophthalmology, Clinical Science, or a related field
- 3–7 years of clinical research and development experience, ideally in ophthalmology
- Real ownership authoring clinical documents including: protocols, IND sections, IB updates, CSR sections
- Deep familiarity with GCP, FDA regulations, and ICH guidelines across Phase 1–3 development
- Comfort with EDC systems and clinical data tools, and a sharp eye for data-driven insight
- A strategic mindset, a bias for autonomy, and the flexibility to thrive in a fast-moving small biotech
Benefits
- This role is remote across the continental US, with quarterly in-person gatherings to keep the team close.
- Real room to grow into new roles as we scale
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