Associate Director - Clinical Affairs

Key Responsibilities Collaborate with Clinical Operations, Clinical Development, and Medical Affairs to ensure trials align with strategic goals. Provide scientific/clinical leadership in designing and executing protocols and clinical development plans. Review and author study protocols, clinical study reports, investigator brochures, periodic safety update reports, international regulatory submissions, and authority responses. Write/review protocol training and site initiation materials; support investigator/study coordinator meetings and scientific presentations/publications. Coordinate timely IND and CTA (and other regulatory) submissions. Ensure global trial compliance (ICH, GCP, and relevant health authorities). Lead clinical data analysis/interpretation for regulatory submissions, publications, and presentations; ensure reports/summaries are accurate and on time. Qualifications Advanced degree in life sciences (PhD, PharmD) or related STEM field. 5+ years’ relevant clinical research/clinical development experience (pharma/biotech, CRO/consulting, or academia). Proven experience designing, managing, and executing clinical trials (early to late stage). Preferred: gene therapy and/or ophthalmology (retina) experience; strong understanding of gene therapy, rare diseases, and genetic disorders. Strong knowledge of FDA/EMA/ICH-GCP and global regulations; leadership/communication; analytical problem-solving. Experience in rare diseases/orphan drug development; strong KOL relationships; prior IND and BLA/NDA submissions. Benefits (explicit) 401(k) Pension Vacation Medical/dental/vision/prescription Flexible benefits (e.g. FSA) Life insurance Time off/leave Well‑being benefits (EAP/fitness/clubs) Company bonus eligibility for full‑time employees Application instruction: If you need accommodation to submit a resume, complete #J-18808-Ljbffr