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Eli Lilly and Company · 2 days ago

Clinical Development Scientist – Lilly Gene Therapy, Sensory

United States

Full-time

Remote

Entry, Mid Level

$63K/yr - $154K/yr

2+ years exp

Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. The Clinical Development Scientist is responsible for managing clinical supply and implementing training for global clinical programs, while collaborating cross-functionally to support clinical and scientific execution of Lilly Gene Therapy programs.

BiotechnologyHealth CareMedicalPharmaceutical

No H1B

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

Qualification

Clinical trial managementClinical supply managementGene therapy knowledgePharmaceutical experienceRegulatory document authorshipStrategic planningData analysisInterpersonal skillsProblem-solving skillsCommunication skillsCross-functional collaborationSelf-motivatedDetail-oriented

Required

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

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