Postdoctoral Fellow -Integrated Clinical Programs

1.

Join Clinical Development, Clinical Operations, Biometrics, Medical Affairs, and Pharmacovigilance teams to advance gene & cell therapy programs from Phase IIII. Unique opportunity to bridge clinical science and business strategy in a fast-paced biotech environment.

Join Ocugen’s Clinical organization (Clinical Development, Clinical Operations, Biometrics, Medical Affairs, and Pharmacovigilance) to contribute across the full spectrum of drug development in gene and cell therapies.

2.

• Support protocol development, amendments, IB/ICF creation, and regulatory submissions (INDs, BLAs, CTAs).
• Participate in medical monitoring: eligibility review, safety signals, and protocol deviations.
• Analyze clinical data for CSRs, publications, abstracts, and posters.
• Contribute to clinical trial execution: site selection, start-up, recruitment, milestones, GCP compliance.
• Assist in pharmacovigilance: safety reviews, narratives, safety reports.
• Collaborate with KOLs, Medical Affairs, Regulatory, and Commercial teams; conduct competitive landscape analysis.

Role Highlights:

• Contribute to 3 BLAs in the next three years from early- to late-stage development.
• Support and Develop Study Protocol, Investigators Brochure, and Informed consent form (ICF) development; oversee site start-up, recruitment, and milestones.
• Conduct medical monitoring: eligibility review, safety assessment, and risk–benefit evaluation.
• Lead/assist in scientific publications, posters, and conference presentations.
• Partner with the Center for Commercialization to support launch readiness.
• Develop, standardize and implement surgical techniques for ocular gene therapy programs.
• Gain cross-functional exposure, bridging clinical science and business strategy from Phase I–III.

QUALIFICATIONS & SKILLS

• MD (Vitreo-retinal surgeon preferred) with strong interest in clinical research & drug development.
• Skilled in scientific writing, data analysis, and cross-functional collaboration.
• Detail-oriented, organized, self-motivated, industry or clinical trial experience a plus

4.

• Operates in an office setting in a sedentary role