What are the responsibilities and job description for the Associate Director, GCP Auditing position at Eikon Therapeutics?
Position
We are seeking an experienced and dynamic Associate Director, 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. 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 (NJ), New York City (NYC) or Millbrae (CA) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.
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 Work Instructions).
- 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
- Post Graduate degree with 8 years of experience or a Bachelor’s degree with 10 years of experience in a relevant field such as Life Sciences, Health Sciences, or a related discipline.
- Extensive knowledge of GCP guidelines, ICH E6(R2), and other relevant US and ex-US 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 $165,000 to $180,500 depending on skills, competency, and the market demand for your expertise.
Salary : $165,000 - $180,500
