Associate Director, Clinical Study Management, EMEA/LATAM

Eikon Therapeutics; Millbrae, Jersey City (CA, NJ); On-site; USD 183,000 - 220,500; Full time

Benefits offered by this job

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

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

English fluency

Multilingual (EMEA/LATAM)

Leadership

Cross-functional collaboration

Regulatory knowledge

Budget management

Strategic planning

Education

Bachelor's degree; or 8 years with postgraduate

Job description

Associate Director, Clinical Study Management, EMEA/LATAM

Jersey City, NJ; Millbrae, CA

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 assignedprotocols across EMEA and LATAM to meet country commitments andregulatory requirements.
• Works with minimal oversight from Clinical Operations Senior Director orDirector, 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 specificationsof 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 keyperformance 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 financesystems.
• Oversee and be in compliance with Eikon processes, SOPs, clinical supply andancillary supplies management, import/export requirements, insurance supplymanagement.
• Expected to lead, manage, hire regional Clinical Operations Study Managementpersonnel across EMEA and LATAM, as required, to support operationalexcellence.
• 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 yearsand a post graduate degree.
• Fluency in English (strong reading, writing, and speaking skills and an ability toeffectively communicate with colleagues and stakeholders at all levels) is requiredand ability to speak multiple EMEA/LATAM languages is a plus for this role.
• In-depth knowledge of ICH-GCP, EMEA/LATAM guidelines and other relevantregulations and guidelines.
• Proven ability to manage clinical studies within timelines and budgets whilemaintaining 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, processesand controls, productivity, quality and project delivery.
• High sense of accountability and urgency in order to prioritize deliverables.
• Growth mindset and capable of working independently.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:

• 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

The expected salary range for this role is $183,000 to $220,500 depending on skills, competency, and the market demand for your expertise.

Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.