Eikontherapeutics

Associate Director, Clinical Study Management, EMEA/LATAM

Jersey City, NJ; Millbrae, CA · Director

Sponsorship not specified$183k-$221kDetected 7 hours ago

GCPForecastingBudgetingClinical TrialsClinical ResearchPatient CareResearchLeadershipCommunicationCollaboration

About the role

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.
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.

Team leader and builder, who manages trial deliverables, timelines in assigned protocols across EMEA and LATAM to meet country commitments and regulatory requirements.
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.
Manage regional resource planning, budgeting, forecasting, and key performance indicators (KPIs) for the region.
Ensure that all study-related documents are accurate, complete, timely and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems.

Minimum of 10 years of related experience with a Bachelor's degree
or 8 years and a post graduate degree.
In-depth knowledge of ICH-GCP, EMEA/LATAM guidelines and other relevant regulations and guidelines.
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.
Expected to lead, manage, hire regional Clinical Operations Study Management personnel across EMEA and LATAM, as required, to support operational excellence.
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.
Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety.
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

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

Keep up to date with regional regulations, health authority frameworks, treatment landscape and country requirements.
Generous paid time off and holiday policies
Enhanced parental leave benefit

This listing is sourced directly from Eikontherapeutics's careers page and normalized into a canonical job model.