Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. Position The Associate Director, Clinical Study Management, EMEA/LATAM will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required.

This role will require onsite presence a minimum of 3 days a week to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. The successful candidate will work closely with cross-functional Clinical Research & Development teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support operational excellence and world class inhouse clinical study management. This role requires a minimum of 3 days per week onsite (or more, as business needs require) in either our Jersey City (NJ), or Millbrae (CA) offices.

About You You are collaborative, solutions oriented, flexible and have global clinical operational experience, with a passion for excellence in advancing patient care in oncology or neuroscience.

What You’Ll Do

Team leader and builder, who manages 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.

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. , 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.

, 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 post graduate degree.