Associate Director, Clinical Study Management, EMEA/LATAM

The role

The Associate Director will oversee the execution of clinical trials in oncology and other therapeutic areas across EMEA and LATAM. This role involves managing trial deliverables, timelines, and regional resources while working with cross-functional teams.

What you will do

• Manage trial deliverables and timelines in assigned protocols across EMEA and LATAM
• Ensure clinical studies are conducted in accordance with approved protocols, ICH-GCP, EMEA, PMDA and other regulations
• Manage ancillary vendor relationships and performance
• Work with finance, legal, external vendors and clinical sites to meet target milestones
• Manage regional resource planning, budgeting, forecasting, and KPIs
• Provide direction to cross-functional study teams
• Provide regular updates on study progress to stakeholders
• Ensure study-related documents are accurate, complete, timely and filed in systems
• Oversee compliance with Eikon processes, SOPs, clinical supply and ancillary supplies management
• Lead, manage, and hire regional Clinical Operations Study Management personnel

Required qualifications

• Minimum of 10 years of related experience with a Bachelor’s degree; or 8 years and a post graduate degree
• Fluency in English
• In-depth knowledge of ICH-GCP, EMEA/LATAM guidelines and other relevant regulations and guidelines
• Proven ability to manage clinical studies within timelines and budgets
• Strong leadership and communication skills
• Experience with management of the budget, resources, headcount, processes and controls, productivity, quality and project delivery
• High sense of accountability and urgency
• Growth mindset and capable of working independently
• Global clinical operational experience

Nice to have

• ability to speak multiple EMEA/LATAM languages

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%)
• optional supplemental employee-paid life/AD&D policies
• Enhanced parental leave benefit
• Daily subsidized lunch program when on-site

About the company

Eikon Therapeutics is a new biopharmaceutical company employing technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases.