Senior Director, Clinical Affairs

About Lilly

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.

Position Summary

The Senior Director, Clinical Affairs plays a critical role in supporting the Clinical Development team by providing scientific and technical expertise and will bring experience in designing and conducting clinical trials. This position serves as a liaison between Clinical Development and other cross-functional groups and is responsible for setting and implementing strategies across the Clinical Development program, providing oversight of strategic study design, study start up, CRO and vendor management, clinical data and safety monitoring, analysis and reporting of studies.

What You’ll Do

• 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.
• Serves as Clinical Development/medical monitor (MM) liaison/point-of-contact for inquiries from both internal and external stakeholders, clinical sites, vendors, clinical research organizations (CROs), etc., collaborates with others in the review of safety narratives and other safety-related guidelines and documentation, supports the Clinical Trial Liaison Team (CTL) by providing timely clinical/medical responses to sites.
• Identifies and mitigates protocol risks, performs ongoing review and monitoring of protocol deviations (PDs), drives PD review meetings, and develops strategies for protocol retraining and improving site compliance.
• 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.
• Contributes as Clinical Development/MM representative during clinical system updates (EDC/IRT).
• Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, study coordinators, clinicians, health authorities, scientists and KOLs, as well as internal groups, including regulatory, clinical operations, data management, data analytics/visualization, biostatistics, clinical supply, and quality.
• Uses Clinical Development/MM expertise to perform ongoing clinical data review.
• Participates in ongoing enhancements and development of team processes, structures, and tools, while supporting the development and training study team members.

Minimum Requirements

• PhD preferred; PharmD with relevant experience may be considered.
• 10+ years of 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).

Additional Preferences

• Gene therapy and/or ophthalmology (retina) experience preferred.
• Ability to proactively predict issues and solve problems.
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team.
• Diplomacy and positive influencing abilities.
• Committed to developing and mentoring team.
• Therapeutic area knowledge relevant to mechanism of action and retinal drug development.
• Understanding of US and Global Regulatory requirements.

Key skills/competency

• Clinical Research
• Clinical Development
• Study Design
• Regulatory Affairs
• CRO Management
• Data Monitoring
• Safety Monitoring
• Protocol Development
• Gene Therapy
• Ophthalmology