Executive Director, Head of Clinical Quality Assurance, Jersey City

Executive Director, Head of Clinical Quality Assurance

2 Days Old

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

We are seeking an individual with strong leadership, advanced understanding of the regulations governing international drug development and the application of Quality Risk Management (QRM) principles, who is highly diplomatic, tactful and detail oriented with exceptional reasoning skills to lead and optimize our emerging Clinical Quality Assurance (CQA) organization supporting all functions within Clinical Research & Development. This position includes operational quality management and inspection management activities.

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

About You

You are recognized as an expert resource on a range of compliance topics, with proven experience in managing oncology compliance programs, and you have superior oral and written communication and leadership skills in both the domestic and international environment, coupled with excellent organizational and project management skills.

What You'll Do

Provide strategic leadership to the CQA function, including team development, resource planning, process optimization, and budget oversight.
Oversee global GCP quality activities to ensure accurate, high-quality clinical trial data that supports global development and regulatory submissions.
Deliver strategic quality management guidance, tools, and resources to clinical teams to promote effective partnerships and trial oversight.
Lead & partner in the implementation of Quality Risk Management (QRM), Quality by Design (QbD), and electronic Quality Management System (QMS) to support high-quality, compliant, operationally excellent drug development.
Develop and maintain methodologies and tools for proactive risk identification and management across clinical trials and suppliers.
Lead the overall strategy to ensure inspection readiness at all times, including inspection preparation and follow-up, and efficiently track Corrective and Preventive Actions (CAPA) and regulatory commitments to completion.
Support M&A activities by ensuring knowledge transfer, inspection readiness, and risk mitigation for clinical research programs.
Conduct periodic reviews of critical clinical trial documentation and inspection-related repositories to ensure completeness and compliance.
Guide and support audit activities, root cause analyses, CAPA development, and drive continuous quality improvement through trend and risk analysis.
Provide guidance and training on relevant GxP regulations and support training while serving as an expert resource for interpreting global regulations and standards for internal stakeholders.
Monitor industry best practices and identify opportunities for consistency and operationally excellent standards for CQA and risk management processes.
Mentor, train and manage department personnel.

Qualifications

A post-graduate degree with 15+ years of relevant experience or a Bachelor's degree with 18+ years of relevant experience in clinical development, clinical quality assurance.
Broad GCP audit compliance and CQA experience in a biopharma sponsor organization.
Proven experience in managing oncology compliance programs and building a culture of quality and operational excellence.
Deep knowledge of QRM, QbD, and QMS is essential.
Demonstrated ability to implement QRM principles aligned with ICH Q9 and ICH E6 R2/R3 guidelines.
Hands-on experience with inspection readiness, audit management, and CAPA management programs is required.
Strong leadership skills, with the ability to influence, coach, and guide colleagues to achieve optimal business outcomes.
Skilled in translating and communicating complex, high-impact issues to a variety of stakeholders.
Able to interpret scientific, technical and legal documents and present information effectively to senior audiences.
Capable of managing multiple priorities independently in a fast-paced environment while ensuring timely and organized deliverables.

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 $252,000 to $275,500 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.

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.

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Location:: Jersey City

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