Clinical Development Scientist – Lilly Gene Therapy, Sensory Full-time

Clinical Development Scientist

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.

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 medical device preferred
• Proven track record of successfully conducting/supporting clinical trials and associated development activities
• Comprehensive understanding of the drug development and approval processes, and clinical trial design
• Strong interpersonal skills required
• Strong problem-solving skills, including the ability to identify and evaluate the critical factors of obstacles or opportunities; given background, experience, and judgment, able to understand potential causes and deliver potential solutions
• Ability to plan and think strategically and critically; intellectually curious, willing to take ownership of the assigned tasks and support clinical/pipeline programs, as needed
• Ability to critically evaluate and analyze scientific data and literature
• Strong communication skills (written and verbal) including the ability to express oneself clearly and concisely, and to message and document key progress and challenges appropriately; excellent presentation skills required
• Capable of representing Lilly Gene Therapy professionally with external global opinion leaders, investigators, vendors, regulatory agencies, and others
• Ability to work effectively cross-functionally, and to serve as clinical resource within the company
• Self-motivated and detail-oriented with ability to prioritize and handle multiple projects

Additional Information

• Travel may be up to 15%, including international travel

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $63,000 – $140,800. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.