Associate Director, Clinical Study Management, EMEA/LATAM

About the role

The Associate Director, Clinical Study Management, EMEA/LATAM will oversee the execution of clinical trials in oncology and other therapeutic areas, requiring a minimum of 3 days a week onsite in either Jersey City (NJ) or Millbrae (CA).

Responsibilities

• Manage trial deliverables, timelines in assigned protocols across EMEA and LATAM to meet country commitments and regulatory requirements.
• Works with minimal oversight from Clinical Operations Senior Director or Director, in collaboration with Clinical Operations teams and Clinical Research and Development functional teams.
• Ensure that clinical studies are conducted in accordance with approved protocols, ICH-GCP, EMEA, PMDA and other relevant regulations and guidelines.
• Manage ancillary (non-CRO) vendor relationships and performance to ensure that clinical studies are completed in accordance with contract specifications of time, cost and quality, ensuring compliance with applicable regulations, guidelines, and company policies.
• Work with finance, legal, external vendors and clinical sites to ensure the assigned studies are meeting the target milestones.
• Proven experience managing multi-center global clinical trials (Phases I–IV), with familiarity with regional nuances.
• Keep up to date with regional regulations, health authority frameworks, treatment landscape and country requirements.
• Manage regional resource planning, budgeting, forecasting, and key performance indicators (KPIs) for the region.
• Provide direction to cross-functional study teams to ensure successful study execution.
• Provide regular updates on study progress to stakeholders (e.g., Clinical Operations, Project & Portfolio Management, Clinical Research).
• Ensure that all study-related documents are accurate, complete, timely and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems.
• Oversee and be in compliance with Eikon processes, SOPs, clinical supply and ancillary supplies management, import/export requirements, insurance supply management.
• Expected to lead, manage, hire regional Clinical Operations Study Management personnel across EMEA and LATAM, as required, to support operational excellence.
• Contribute to initiatives and projects adding value to Eikon Therapeutics.

Qualifications

• Minimum of 10 years of related experience with a Bachelor’s degree; or 8 years and a postgraduate degree.
• Fluency in English (strong reading, writing, and speaking skills and an ability to effectively communicate with colleagues and stakeholders at all levels) is required, and ability to speak multiple EMEA/LATAM languages is a plus for this role.
• 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 while maintaining high quality standards and patient safety.
• Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams.
• Experience with management of the budget, resources, headcount, processes and controls, productivity, quality and project delivery.
• A high sense of accountability and urgency in order to prioritize deliverables.
• A growth mindset and capable of working independently.

Benefits

• 401(k) 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