Sr. Director Clinical Development – Lilly Gene Therapy, Sensory

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.

Employment Type: Full time

Role Overview

The Sr. Director, Clinical Development is an experienced clinical trialist who will be responsible for the clinical and scientific execution of global clinical programs. They will play a key role in strategy development and will ensure timely planning, implementation, management, and reporting of clinical studies and trials. The successful candidate will collaborate cross-functionally to support clinical programs and pipeline programs as needed and will provide insight into clinical development programs both externally and internally (e.g., Medical Affairs, Commercial, CROs, etc.). They will provide clinical / scientific support for training of clinical sites and CROs.

Responsibilities

• Lead the development of clinical strategies and plans for assigned programs and work with program teams to ensure integration of clinical strategies and plans into program targets and goals
• Collaborate with cross-functional teams to support clinical programs and achieve organizational and corporate goals
• Represent clinical development in program teams and cross-functional teams in decision making and problem solving, as well as development of Standard of Procedures (SOPs) and internal processes
• Provide leadership, mentorship and guidance to clinical development team; manage direct reports as needed
• Serves as the clinical / scientific representative for assigned clinical studies and trials; facilitate the clinical / scientific execution of clinical protocol(s) / programs (including interventional, non-interventional, validation, natural history, and registry trials / studies)
• Supports the clinical operations team, including clinical trial manager, in achieving study deliverables, including adherence to budget and timelines, and developing study documents, including training materials, study procedures, and study plans
• Supports the implementation and conduct of clinical studies and trials in all scientific aspects (e.g., scientific advisory committees, data safety monitoring boards, medical monitoring)
• Reviews and evaluates emerging clinical trial data and oversees data interpretation; supports Communication teams in publication of data and development of materials (e.g., slide decks, posters, manuscripts, abstracts, etc.) based on clinical trial data
• Supports authorship and review of clinical / regulatory documents (e.g., protocols, Investigator Brochures, clinical study reports, briefing packages, etc.); collaborates cross-functionally in planning regulatory strategy and communications
• Serves as a clinical representative on internal and external teams; participates in development, review, and / or presentation of clinical data in internal and external meetings, as needed (e.g., DSMB, training, Investigator meetings, Board presentations, etc.)
• Other duties as assigned or as business needs require

Basic Qualifications

• Master's degree or Advanced degree (ie., PharmD, PhD, etc.,) in the Life Sciences required.
• A minimum of ten (10) years of pharmaceutical and/or clinical experience

Additional Skills / Preferences

• Prior pharma/biotech or academic experience in rare disease, otology, audiology, gene therapy, cellular therapy, and/or medical device a plus
• Proven track record of successfully conducting / supporting global clinical trials and associated development activities
• Comprehensive understanding of the drug development and approval process and clinical trial design
• Strong interpersonal skills