Clinical Development Scientist – 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.

Organization Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Role Overview

The Clinical Development Scientist is a clinical trialist with clinical trial experience responsible for management of clinical supply (in collaboration with Supply Chain) and implementation of clinical supply/device trainings (in collaboration with other functional areas) for global clinical programs. They will be responsible for development of training materials and ensure timely planning and implementation of clinical supply/device trainings.

The Clinical Development Scientist will also collaborate cross-functionally to support the clinical and scientific execution of all Lilly Gene Therapy clinical and preclinical programs, as needed. They will ensure timely planning, implementation, management, and reporting of clinical studies and trials. The successful candidate will collaborate cross-functionally to support all Lilly Gene Therapy Sensory clinical programs and provide clinical/scientific support to clinical trial sites and CROs.

Responsibilities

• Develop and manage updates of trial documents related to clinical supplies
• Develop training materials for clinical supply training sessions for clinical trial sites and CROs (if applicable) and manage the training material updates
• Collaborate both internally and externally to facilitate clinical trial site activities to ensure sites are ready for dose administration at site activation and throughout the trial
• Lead the efforts to conduct training sessions related to clinical materials and supplies
• Serve as the clinical development representative to work with Clinical Supply Management in supply management, demand forecasting, shipment operation/logistics, etc.
• Serve as the clinical/scientific representative for assigned clinical trials, as well as program teams, and facilitate the clinical/scientific execution of clinical and preclinical programs, as needed
• Support the clinical operations team, including clinical trial manager, in achieving trial deliverables, including adherence to budget and timelines, and developing trial documents, procedures, and plans
• Support authorship and review of clinical/regulatory documents (e.g., clinical protocols, Investigator Brochures, clinical study reports, briefing packages, etc.); collaborate cross-functionally in planning regulatory strategy and communications
• Other duties as assigned or as business needs require

Basic Qualifications

• Bachelor’s degree in the Life Sciences required
• A minimum of two (2) years of pharmaceutical and/or clinical experience
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role

Additional Skills / Preferences

• Master's or higher level degree preferred (ie. PharmD, PhD, etc,..)
• Global clinical trials in the rare disease area
• Clinical/investigational pharmacy with gene therapy products or clinical supply management
• Prior pharma/biotech or academic experience in rare disease, otology, audiology, gene therapy, cellular therapy, and/or med