Summary/Objective
Works collaboratively with clinical project team staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting. Ensures completeness, correctness and consistency of clinical data and data structure. Responsibilities include: Implement the data management portions of clinical research projects. Review study protocols and assist site coordinators, investigators, and field clinical […]
Quark reached agreement with FDA on the overall Phase 3 trial design with a new innovative primary endpoint
Fremont, CA – July 9, 2018 – Quark Pharmaceuticals, Inc., a late clinical-stage pharmaceutical company and leader in the discovery and development of novel RNAi-based therapeutics for unmet medical needs, today announced the first patient dosed in the […]
Reports to
Executive Vice President, Regulatory Affairs
Summary/Objective
This position is responsible for supporting all regulatory projects in conjunction with other regulatory and clinical professionals
Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Prepare regulatory submissions, e.g., FDA IND supplements and international clinical trial applications (CTA).
Coordinate submission components, perform final preparation, assembly, […]
Fremont, CA – November 7, 2017 – Quark Pharmaceuticals, Inc., a late clinical-stage pharmaceutical company and leader in the discovery and development of novel RNAi-based therapeutics for unmet medical needs, today announced that positive results from a Phase 2 clinical study on its lead program QPI-1002 will be presented as an oral abstract at the […]
Fremont, CA – November 4, 2017 – Quark Pharmaceuticals, Inc., a late clinical-stage pharmaceutical company and leader in the discovery and development of novel RNAi-based therapeutics for unmet medical needs, presented today at the late breaking plenary session of the American Society of Nephrology (ASN) / Kidney Week positive results from a Phase 2 clinical study, […]
Fremont, CA – November 1, 2017 – Quark Pharmaceuticals, Inc., a late clinical-stage pharmaceutical company and leader in the discovery and development of novel RNAi-based therapeutics for unmet medical needs, today announced that Phase 2 data on its lead program QPI-1002 will be presented as an oral abstract at the American Society of Nephrology (ASN) […]
FREMONT, Calif., Oct. 9, 2017 Quark Pharmaceuticals, Inc., a late clinical-stage pharmaceutical company and leader in the discovery and development of novel RNAi-based therapeutics for unmet medical needs, is delivering an oral presentation at the 6th Annual RNAi China Conference in Jiangsu.
The presentation will summarize the preclinical efficacy data for inhaled small interfering RNA (siRNA) against an undisclosed […]
QPI 1002 Meets Primary & Multiple Secondary Endpoints
A statistically significant reduction in AKI incidence following cardiac surgery was demonstrated
First multicenter Phase 2 clinical study with an investigational drug for the prevention of AKI to meet primary endpoint
QPI-1002 appears to be well tolerated with no safety issues identified
Fremont, CA – July 27, 2017 – Today, Quark […]
Full-time or Contractor
Experienced in writing study reports for drug discovery programs including in vitro and in vivo Pharmacology studies
Reporting to CSO and working closely with Project Directors
M.Sc. in Biology or higher with at least 3 years industry experience
Experience in preparation of IND packages – advantage
Proficient in English (level of mother tongue)
FREMONT, Calif., October 14, 2016 — Quark Pharmaceuticals, Inc. today announced the launch of www.EyeActNow.com to promote public awareness and subject recruitment for a global Phase II/III clinical study evaluating QPI-1007, an investigational drug designed to stop further vision loss in patients with early diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy, or NAION.
Often referred to […]