Clinical Scientist/Senior (Biotech)

TL;DR

Clinical Scientist/Senior (Biotech): Supporting the design and execution of Clinical Development Plans with an accent on clinical study design, data validation, and regulatory submissions. Focus on medical monitoring, writing clinical protocols, and collaborating with cross-functional study teams in the ophthalmology and gene therapy domains.

Location: Remote (Must be based in the US)

Salary: $70 - $80 per hour

Company

hirify.global is a wholly owned subsidiary of Eli Lilly and Company specializing in gene therapy.

What you will do

• Design and write clinical protocols, ICFs, charters, and operational manuals.
• Develop training materials for investigational sites to ensure quality execution of trial procedures.
• Act as a point of contact for cross-functional teams regarding study protocols and trial procedures.
• Provide medical monitoring and oversight of CRO activities, including cleaning and analyzing efficacy data.
• Draft clinical sections for IND submissions, Investigator Brochures, and Clinical Study Reports.
• Evaluate innovative trial designs and analyze data from ongoing trials to support future planning.

Requirements

• MD, PhD, OD, or PharmD with ophthalmology experience (preferably retina).
• 5-7 years of experience in a clinical research-related role.
• Proficient knowledge of GCP/ICH, the drug development process, and study design.
• Ability to support program-specific data review, trend identification, and data interpretation.
• Experience working with CROs and managing Phase I-III US and Global clinical trials.
• Strong medical writing skills and proficiency in medical terminology.

Nice to have

• Experience in Gene Therapy.
• Knowledge of ocular therapies.
• Proficiency with Electronic Data Capture tools such as RAVE or J-Review.

Culture & Benefits

• Remote work arrangement.
• Opportunity to work on cutting-edge gene therapy developments.
• Collaborative environment within a subsidiary of a global pharmaceutical leader.
• Contract duration of 6-12 months.