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Associate Director, GCP Auditing

Employer
Eikon Therapeutics
Location
Hayward, California
Start date
Nov 16, 2023

Job Details

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 experienced and dynamic Associate Director, Auditor, Clinical Quality Assurance to lead our GCP auditing efforts. The successful candidate will play a pivotal role in ensuring that our clinical trials adhere to Good Clinical Practice (GCP) guidelines and maintain the highest standards of quality.  This includes internal audits, site audits, and vendor audits. 

 

About You

 

You have a passion for innovation, independence, an entrepreneurial spirit, and a strong desire to learn and grow with the best professionals in the industry.

 

What You’ll Do

 

  • Lead and manage the Clinical Quality Assurance (CQA) audit program, ensuring compliance with GCP, applicable regulations, and company SOPs.
  • Collaborate closely with Clinical Development Vendor Oversight team to ensure vendor qualification process is robust and timely.
  • Develop and execute risk-based audit plans, conduct audits of clinical trial activities, and provide timely and accurate audit reports.
  • Provide expert guidance to cross-functional teams on GCP compliance, protocol adherence, and regulatory requirements.
  • Collaborate closely with the Clinical Operations team to identify and address quality-related issues, deviations, and non-compliance events.
  • Review and approve essential study documents, including protocols, informed consent forms, and clinical study reports.
  • Contribute to the development of procedural documents (e.g., SOPs and WIs).
  • Develop and implement GCP training programs for internal staff and external partners/vendors involved in clinical trials.
  • Lead/facilitate mock inspections as necessary.
  • May represent the company in regulatory inspections and audits, and lead the preparation and response efforts.
  • Stay abreast of industry trends, regulations, and best practices related to clinical quality assurance and GCP.

 

Qualifications

 

  • Advanced degree in a relevant scientific discipline; additional certifications (e.g., RAC, CQA) highly desirable.
  • 10-15 years of progressive experience in clinical quality assurance or a related field in the pharmaceutical or biotechnology industry.
  • Extensive knowledge of GCP guidelines, ICH E6(R2), and other relevant regulatory requirements.
  • Strong leadership, analytical, and problem-solving skills, with meticulous attention to detail and accuracy.
  • Exceptional communication and interpersonal skills, with a proven ability to lead and collaborate in a cross-functional team environment.
  • Demonstrated experience in conducting clinical trial audits and inspections.
  • Previous experience in pharmacovigilance auditing is a plus.
  • Ability to travel up to 50% (domestic and international).

 

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 $185,000 to $204,000 depending on skills, competency, and the market demand for your expertise.

Company

Eikon is a pioneering drug discovery and development company that leverages superior engineering and high-performance computing to analyze single molecule protein behavior in living cells. We are engineering a battery of innovative tools and technologies for biological exploration in drug discovery and beyond.

Eikon thrives on the energy and creativity of interdisciplinary teams. We are physicists and chemists, biologists and engineers. We spend our days context-switching between multiple scientific languages. We work with lasers, super-resolution microscopes, and robot arms. We leverage machine learning, cell line engineering, and the collective intelligence of world-class scientists and technologists to observe therapeutically relevant biology in a way no one has before.

We’re endlessly curious, intellectually honest and we love what we do. We’re driven to learn the true mechanisms of biology and pharmacology at the molecular level, to make the biggest difference in as many lives as possible.

Company info
Website
Location
3929 Point Eden Way
Hayward
CA
94545
United States

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