Sr. Director - Clinical Affairs
Eli Lilly and Company
6 hours ago
Remote friendly (Indiana, United States)
United States
Medical Affairs
Sr. Director of Clinical Affairs will play a pivotal role in the clinical development of gene therapy programs, overseeing strategic planning, execution, and management of clinical trials, ensuring compliance with regulatory requirements, scientific standards, and company goals; responsible for cross-functional collaboration with internal teams, key opinion leaders, clinical investigators, and regulatory agencies.
Key Responsibilities:
- Collaborate with Clinical Operations, Clinical Development, and Medical Affairs to ensure clinical trials align with overall strategic goals.
- Provide scientific and clinical leadership in the design and execution of protocols and clinical development plans.
- Review and author study protocols, clinical study reports, investigator brochures, periodic safety update reports, international regulatory submissions, and responses for US and global health authority interactions.
- Write and/or review content for protocol training; site initiation visits; investigator/study coordinator meetings; clinical presentation slides; scientific meetings, conferences, and other presentations; contribute to scientific publication of study results.
- Collaborate to ensure timely submissions of IND applications, CTAs, and other regulatory documents.
- Ensure compliance with global clinical trial regulations and guidelines, including ICH and GCP.
- Lead clinical data analysis and interpretation to support regulatory submissions, scientific publications, and presentations.
- Ensure clinical study reports, clinical development summaries, and other key documents are prepared accurately and on time.
- Participate in preparation and review of abstracts, posters, and manuscripts for conferences and publications.
Qualifications:
- Advanced degree in life sciences (PhD, PharmD) or related STEM field.
- 8+ years of relevant clinical research and/or clinical development experience (pharma/biotech, CRO/consulting, or academia).
- Proven experience designing, managing, and executing clinical trials from early- through late-stage.
Preferred/Additional Requirements:
- Gene therapy and/or ophthalmology (retina) experience preferred.
- Strong understanding of gene therapy, rare diseases, and genetic disorders.
- In-depth knowledge of regulatory requirements (FDA, EMA, ICH/GCP) and global clinical trial regulations.
- Excellent leadership, communication, analytical, problem-solving, and decision-making skills.
- Experience in rare diseases/orphan drug development.
- Strong relationships with key opinion leaders.
- Prior experience with IND and BLA/NDA submissions.
Compensation & Benefits (as stated):
- Anticipated wage: $156,000 - $288,200.
- Full-time employees may be eligible for a company bonus.
- Comprehensive benefits for eligible employees, including 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance, time off/leave, and well-being benefits.
Application instructions:
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.
Key Responsibilities:
- Collaborate with Clinical Operations, Clinical Development, and Medical Affairs to ensure clinical trials align with overall strategic goals.
- Provide scientific and clinical leadership in the design and execution of protocols and clinical development plans.
- Review and author study protocols, clinical study reports, investigator brochures, periodic safety update reports, international regulatory submissions, and responses for US and global health authority interactions.
- Write and/or review content for protocol training; site initiation visits; investigator/study coordinator meetings; clinical presentation slides; scientific meetings, conferences, and other presentations; contribute to scientific publication of study results.
- Collaborate to ensure timely submissions of IND applications, CTAs, and other regulatory documents.
- Ensure compliance with global clinical trial regulations and guidelines, including ICH and GCP.
- Lead clinical data analysis and interpretation to support regulatory submissions, scientific publications, and presentations.
- Ensure clinical study reports, clinical development summaries, and other key documents are prepared accurately and on time.
- Participate in preparation and review of abstracts, posters, and manuscripts for conferences and publications.
Qualifications:
- Advanced degree in life sciences (PhD, PharmD) or related STEM field.
- 8+ years of relevant clinical research and/or clinical development experience (pharma/biotech, CRO/consulting, or academia).
- Proven experience designing, managing, and executing clinical trials from early- through late-stage.
Preferred/Additional Requirements:
- Gene therapy and/or ophthalmology (retina) experience preferred.
- Strong understanding of gene therapy, rare diseases, and genetic disorders.
- In-depth knowledge of regulatory requirements (FDA, EMA, ICH/GCP) and global clinical trial regulations.
- Excellent leadership, communication, analytical, problem-solving, and decision-making skills.
- Experience in rare diseases/orphan drug development.
- Strong relationships with key opinion leaders.
- Prior experience with IND and BLA/NDA submissions.
Compensation & Benefits (as stated):
- Anticipated wage: $156,000 - $288,200.
- Full-time employees may be eligible for a company bonus.
- Comprehensive benefits for eligible employees, including 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance, time off/leave, and well-being benefits.
Application instructions:
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.