Sr. Director - Clinical Affairs

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The 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. This position will ensure that clinical studies are conducted in compliance with regulatory requirements, scientific standards, and company goals. The Sr. Director will be responsible for cross-functional collaboration with internal teams, key opinion leaders, clinical investigators, and regulatory agencies.

Key Responsibilities:

Clinical Strategy, Planning, and Execution:

• Collaborate with Clinical Operations, Clinical Development, and Medical Affairs to ensure clinical trials align with the company's overall strategic goals.

• Provide scientific and clinical leadership in the design and execution of protocols and clinical development plans.

• Collaborate with Clinical Development to review and author study protocols, clinical study reports, investigator brochures, periodic safety update reports, international regulatory submissions, and responses to support interactions with US and Global Health Authorities

• Writes and/or reviews content for protocol training, site initiation visits, and investigator/study coordinator meetings, clinical presentation slides, scientific meetings, conferences, other events and presentations, and contributes to scientific publication of study results as needed

Regulatory and Compliance:

• Collaborate with clinical team to ensure timely submissions of Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), and other regulatory documents.

• Ensure compliance with global clinical trial regulations and guidelines, including ICH, GCP, and relevant health authorities.

Data Management and Reporting:

• Lead clinical data analysis and interpretation to support regulatory submissions, scientific publications, and presentations.

• Ensure that clinical study reports, clinical development summaries, and other key documents are prepared accurately and on time.

• Participate in the preparation and review of abstracts, posters, and manuscripts for scientific conferences and publications.

Qualifications:

• Advanced degree in life sciences (PhD, PharmD) or related STEM field.

• 8+ years of relevant experience in clinical research and/or clinical development experience within the pharmaceutical or biotech industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of fore mentioned.) 

• Proven experience in designing, managing, and executing clinical trials, from early-stage development through late-stage clinical studies.

Qualifications:

• Gene therapy and/or ophthalmology (retina) experience preferred.

• Strong understanding of gene therapy, rare diseases, and genetic disorders.

• Proven experience in designing, managing, and executing clinical trials, from early-stage development through late-stage clinical studies.

• In-depth knowledge of regulatory requirements (FDA, EMA, ICH/GCP) and global clinical trial regulations.

• Excellent leadership and communication skills, with the ability to work effectively across teams and influence key stakeholders.

• Strong analytical, problem-solving, and decision-making abilities.

• Experience in rare diseases or orphan drug development.

• Strong relationships with key opinion leaders in the field of gene therapy and rare diseases.

• Prior experience with IND and BLA/NDA submissions.

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