Director, Trial Master File Operations

June 22

Apply Now

Receive Emails with Similar Jobs

Eikon Therapeutics

WebsiteLinkedInAll Job Openings

Pioneering a new method of drug discovery based on tracking and measuring movement of individual proteins in live cells

201 - 500

Description

• As the Director of Trial Master File Operations, you will be responsible for leading the TMF (Trial Master File) operations function for clinical trials across Eikon Therapeutics. • This is a senior-level position that requires a strategic thinker with the ability to drive change and improve processes. • You will be accountable for ensuring the completeness, accuracy, and regulatory compliance of TMFs, and overseeing all TMF-related activities across the clinical trial portfolio.

Requirements

• Minimum of 12+ years of experience with a Bachelor's degree, or 10+ years of experience with a post graduate degree • Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operations • Experience with electronic Trial Master File systems (e.g., Veeva) and related technology platforms • Proficient knowledge of DIA TMF Reference Model • Knowledge of clinical trial operations and processes, preferred • Demonstrated leadership skills to drive results to achieve optimal outcomes • Experience in managing a team and providing leadership to drive performance • Excellent communication skills and ability to collaborate with cross-functional teams • Ability to manage multiple projects simultaneously and meet tight deadlines • Ability to work onsite at least 3 days a week

Benefits

• 401k plan with company matching • Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%) • Mental health and wellness benefits • Weeklong summer and winter holiday shutdowns • Generous paid time off and holiday policies • Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies • Enhanced parental leave benefit • Daily subsidized lunch program when on-site