Qureos Mentor

Eikon Therapeutics

<div><div>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.</div>
Position

We are seeking a highly experienced leader for the role of Executive Director, Clinical Study Management, within the Clinical Operations organization. This individual will lead and manage an expanding global FTE and FSP workforce and will be accountable for the operationally excellent execution of all clinical trials, leveraging internal clinical operations resources to efficiently deliver high-quality clinical data that support regulatory approval of Eikon Therapeutics' drug candidates across all therapeutic areas. The Head of Clinical Study Management will ensure adherence to Good Clinical Practice (GCP) and to local and global policies and procedures, maintaining inspection readiness and overseeing trial quality, audit responses, and CAPA completion. Serving as the single point of accountability for the operational execution of clinical trials across all phases, this leader will collaborate cross-functionally with key stakeholders in Clinical Research &amp; Development (R&amp;D), Finance, Clinical Supplies, Business Development, and Legal, and will serve as a member of the Clinical Development Operations Leadership Team.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the significant team growth &amp; collaboration.

About You

You are agile of mind, innovative, flexible and a collaborative leader with a consistent history of systematic, operationally excellent delivery of global clinical trials, including building high performing teams. You have extensive experience developing clinical operations personnel in phase I-III clinical trials and a passion for operational excellence and advancing patient care.

What You'll Do
<ul>
<li>Provide strategic leadership to Clinical Study Management by building, developing, and mentoring a global team, optimizing structure, processes, and resources to deliver exceptional results across all therapeutic programs.</li>
<li>Oversee end-to-end clinical study execution to ensure all trials are delivered on time, within budget, and to requisite quality standards supporting global regulatory submissions.</li>
<li>Manage clinical trial operations through proactive oversight of timelines, budgets, vendor performance, and cross-functional dependencies to ensure operational excellence.</li>
<li>Partner cross-functionally within a matrix organization to align internal and external stakeholders on study objectives, deliverables, and priorities.</li>
<li>Collaborate with Functional Service Providers (FSPs) and internal stakeholders to ensure appropriate resourcing, capacity planning, and operational support across all studies.</li>
<li>Strengthen Sponsor of Choice relationships through effective program lifecycle management, prioritization, and engagement with key opinion leaders and global site networks.</li>
<li>Partner with Clinical Quality Assurance to ensure inspection readiness, GCP compliance, and continuous improvement through proactive audit preparation and CAPA management.</li>
<li>Drive strategic initiatives that enhance patient enrollment, study delivery, and departmental infrastructure, including SOP optimization and process innovation.</li>
<li>Serve as a key member of the Clinical Development Operations Leadership Team, representing Clinical Study Management in strategic planning, governance, and portfolio-level discussions.</li>
<li>Foster a culture of performance, accountability, and professional growth by developing, coaching, and retaining top talent while embracing metrics and performance standards (KPIs).</li>
</ul>
Qualifications
<ul>
<li>Post Graduate degree with 15+ years of experience or a Bachelor's degree with 18+ years of experience in Clinical Trial Operations working on multi-phase, multi-therapeutic and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation.</li>
<li>Operational excellence mindset with extensive inhouse clinical operations global oncology management experience.</li>
<li>A proven track record of contribution to and delivery of global oncology clinical trials that support global regulatory submissions, clean regulatory inspections and product approvals or marketing authorizations.</li>
<li>Significant experience with inhouse clinical operations delivery model required.</li>
<li>Significant management experience in a clinical trial setting with the ability to service and collaborate with different R&amp;D stakeholders in a matrix organization.</li>
<li>Management expertise should cover management of budget, resources, headcount, processes (and controls), productivity, quality and project delivery.</li>
<li>A complete understanding of ICH GCP and Global/Regional/Local regulatory requirements is required.</li>
<li>Strong communication skills.</li>
<li>Strategic thinking and high emotional intelligence.</li>
<li>Strong leadership that will attract, motivate, inspire, develop, retain talented staff and enable and drive alignment with the goals, purpose and mission of Eikon Therapeutics.</li>
<li>PMP certification a plus; MBA preferred.</li> 
</ul>
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
<ul><li>401k plan with company matching
</li><li>Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
</li><li>Mental health and wellness benefits
</li><li>Weeklong summer and winter holiday shutdowns
</li><li>Generous paid time off and holiday policies
</li><li>Life/AD&amp;D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&amp;D policies
</li><li>Enhanced parental leave benefit
</li><li>Daily subsidized lunch program when on-site
</li></ul>The expected salary range for this role is $278,000 to $304,000 depending on skills, competency, and the market demand for your expertise.<div>
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.</div></div>

Executive Director, Clinical Study Management

Join Eikon Therapeutics and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Eikon Therapeutics

ABOUT_COMPANY

Executive Director, Clinical Study Management