Associate Director, GCP Auditing
- Job Type: Full-Time
- Function: Accounting/Finance
- Industry: Biotechnology
- Post Date: 11/20/2023
- Website: eikontx.com
- Company Address: 3929 Point Eden Way, Hayward, CA 94545
About Eikon TherapeuticsEikon 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. 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.
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.
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.
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.
- 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.
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
In accordance with the Company’s duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA’s emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California’s Fair Employment and Housing Act, you will need to contact the Company’s Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.
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.