Clinical Development Scientist – Lilly Gene Therapy, Sensory

Stellenbeschreibung:

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