Full-Time

Executive Director

Head of Clinical Quality Assurance

Confirmed live in the last 24 hours

Eikon Therapeutics

Eikon Therapeutics

201-500 employees

Biotech startup developing innovative medicines

Compensation Overview

$252k - $275.5k/yr

+ Bonus + Equity Compensation

Expert

San Bruno, CA, USA + 1 more

More locations: New York, NY, USA

Hybrid

Minimum of 3 days a week of onsite presence required.

Category
QA & Testing
Quality Assurance
Required Skills
Google Cloud Platform
Requirements
  • 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.
Responsibilities
  • 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.

Eikon Therapeutics develops new medicines in the pharmaceutical industry by studying biological systems to identify drug targets. They utilize a proprietary single-molecule tracking platform to visualize protein movements in living cells, combined with artificial intelligence and automation for precise molecular interaction analysis. Their diverse team integrates science and engineering to create therapies aimed at improving the lives of patients with serious diseases. Eikon stands out from competitors by focusing on the dynamic aspects of biology rather than static chemical processes.

Company Size

201-500

Company Stage

Series D

Total Funding

$1.1B

Headquarters

Hayward, California

Founded

2019

Simplify Jobs

Simplify's Take

What believers are saying

  • Eikon raised $350.7 million in Series D, indicating strong investor confidence.
  • Expansion in Millbrae, California, supports growth and innovation in biotech.
  • Eikon's focus on innovative therapies aligns with the growing trend of personalized medicine.

What critics are saying

  • Intense competition from biotech unicorns like Abogen Biosciences may impact market position.
  • Significant investment in Millbrae expansion could strain financial resources.
  • Reliance on venture capital funding may pressure Eikon for rapid returns.

What makes Eikon Therapeutics unique

  • Eikon uses a proprietary single-molecule tracking platform for real-time protein movement analysis.
  • The company integrates AI and advanced automation for large-scale molecular interaction inventory.
  • Eikon's diverse team combines expertise in biology, engineering, and chemistry for innovative therapies.

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Benefits

401(k) Company Match

Medical (premiums covered by Eikon at 95%)

Dental Insurance

Vision Insurance

Mental Health Support

Unlimited Paid Time Off

Paid Holidays

Life Insurance

Enhanced Parental Leave

Daily subsidized lunch program

Growth & Insights and Company News

Headcount

6 month growth

1%

1 year growth

1%

2 year growth

0%
Intelligence360
May 7th, 2025
Eikon Therapeutics Inc To Spend $350.7 Million To Expand In Millbrae California.

Eikon Therapeutics Inc to spend $350.7 Million to expand in Millbrae California. Eikon Therapeutics Inc to spend $350.7 Million to expand in Millbrae California.Millbrae, California — According to state and local development sources, Eikon Therapeutics Inc. plans to invest $350,700,000.00 to build out new space in Millbrae. The company plans to occupy the new space in Millbrae, on or about May 1, 2027. According to the company website Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the interface of biology, engineering and chemistry to discover novel treatments for life-threatening diseases. Eikons 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

BioSpace
Mar 14th, 2025
Nurix Therapeutics Appoints Drug Development Expert Roy D. Baynes, MB.Bch., M.Med., Ph.D., to Its Board of Directors

Dr. Baynes, who currently serves as executive vice president and chief medical officer of Eikon Therapeutics, has had a distinguished career in hematology and oncology and over 22 years of clinical leadership experience in pharmaceutical and biotech companies.

Chronicles Magazine
Mar 3rd, 2025
Family office investors demonstrate appetite for innovation and diversity

Another significant entity, Soros Capital - managed by Robert Soros, son of the billionaire George Soros - participated in a $350.7 million financing round for Eikon Therapeutics.

Business Wire
Feb 27th, 2025
Eikon Therapeutics Secures $350.7 Million Series D to Advance Clinical-Stage Programs and Future Pipeline

Eikon Therapeutics, Inc., a pivotal-stage biotechnology company that integrates advanced engineering with cutting-edge molecular and cell biology to a

Stat News
Feb 26th, 2025
Eikon Therapeutics raises $350 million

Eikon Therapeutics, led by former Merck RD head Roger Perlmutter, raised $350 million, bringing its total funding to $1.1 billion. The funds will support the clinical development of cancer drugs, including an immunotherapy in Phase 3 for melanoma and two PARP inhibitors. The financing round included investors like Lux Capital and Alexandria Venture Investments.