Associate Director - Clinical Affairs

Director of Clinical Affairs (Gene Therapy)

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 (explicit): If you need accommodation to submit a resume, complete https://careers.lilly.com/us/en/workplace-accommodation.