Associate Director, Clinical Study Management - EMEA/LATAM

Eikon Therapeutics; Millbrae, Jersey City (CA, NJ); Vor Ort; USD 183.000 - 220.500; Vollzeit

Benefits dieser Stelle

401k plan with company matching

Medical, dental and vision insurance (

Mental health and wellness benefits

Weeklong summer and winter shutdowns

Generous paid time off

Life/AD&D Insurance and optional add'l

Enhanced parental leave

Daily subsidized lunch on-site

Zusammenfassung

Eikon Therapeutics is seeking an Associate Director of Clinical Study Management for EMEA/LATAM, with onsite presence in Jersey City or Millbrae. You will lead cross-functional teams to deliver high-quality oncology trials, ensure regulatory compliance, and manage regional budgets and resources.

The role requires 10+ years of experience (or 8+ with a postgraduate degree), English fluency, and a track record in global trials.

Qualifikationen

• Bachelor's degree; or 8 years with a post graduate degree.
• Fluency in English with ability to communicate with stakeholders at all levels; multilingual is a plus.
• In-depth knowledge of ICH-GCP, EMEA/LATAM guidelines and regulations.
• Proven ability to manage clinical studies within timelines and budgets while ensuring patient safety.
• Strong leadership and communication skills; ability to work cross-functionally.

Aufgaben

• Lead trial delivery and timelines across EMEA/LATAM to meet commitments and regulatory requirements.
• Collaborate with Clinical Operations and R&D teams with minimal supervision.
• Ensure studies comply with approved protocols, ICH-GCP, and regional guidelines.
• Manage vendor relationships to ensure time, cost and quality targets.
• Coordinate with finance, legal, vendors and sites to meet milestones.
• Demonstrate experience managing multi-center global trials (Phases I–IV).
• Stay updated on regional regulations and health authority frameworks.
• Oversee regional resource planning, budgeting and KPIs.
• Direct cross-functional study teams to ensure successful execution.
• Provide updates to stakeholders on study progress.
• Maintain proper study documentation in TMF and related systems.
• Oversee compliance with processes, SOPs and supply management.
• Lead hiring of regional study management personnel as needed.
• Contribute to initiatives adding value to Eikon.

Kenntnisse

English fluency

Multilingual (EMEA/LATAM)

Leadership

Cross-functional collaboration

Regulatory knowledge

Budget management

Strategic planning

Ausbildung

Bachelor's degree; or 8 years with postgraduate

Jobbeschreibung

Eikon Therapeutics is seeking an Associate Director of Clinical Study Management for EMEA/LATAM, with onsite presence in Jersey City or Millbrae. You will lead cross-functional teams to deliver high-quality oncology trials, ensure regulatory compliance, and manage regional budgets and resources.

The role requires 10+ years of experience (or 8+ with a postgraduate degree), English fluency, and a track record in global trials.