Clinical Development Scientist – Lilly Gene Therapy, Sensory

Role Summary

Clinical Development Scientist – Lilly Gene Therapy, Sensory. A clinical trialist responsible for management of clinical supply and implementation of training for global clinical programs, with cross-functional collaboration to support the clinical and scientific execution of Lilly Gene Therapy programs. Location: USA Remote. Travel may be up to 15%, including international travel.

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 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 and program teams, facilitating clinical/scientific execution of clinical and preclinical programs, as needed
• Support the clinical operations team 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; collaborate cross-functionally in planning regulatory strategy and communications
• Other duties as assigned or as business needs require

Qualifications

• Required: Bachelor’s degree in the Life Sciences
• Required: Minimum of two (2) years of pharmaceutical and/or clinical experience
• Required: Authorized to work in the United States on a full-time basis (no sponsorship)
• Preferred: Master’s or higher degree (e.g., PharmD, PhD)

Skills

• Preferred: Global clinical trials in the rare disease area
• Preferred: Clinical/investigational pharmacy with gene therapy products or clinical supply management
• Preferred: Experience in rare disease, otology, audiology, gene therapy, cellular therapy, and/or medical devices
• Preferred: Proven track record of successfully conducting/supporting clinical trials and development activities
• Preferred: Understanding of drug development, regulatory processes, and clinical trial design
• Required/Preferred: Strong interpersonal and communication skills (written and verbal) with excellent presentation skills
• Preferred: Ability to think strategically, evaluate scientific data, and work cross-functionally
• Preferred: Ability to prioritize and manage multiple projects independently

Education

• Bachelor’s degree in the Life Sciences (Required)

Additional Requirements

• Travel may be up to 15%, including international travel
• Location: USA Remote