List of Jobs
Director, GCP Quality Assurance
|Location||San Diego, CA|
|How to Apply|
Applicants who meet one of our vacant position designation criteria should send their resume to email@example.com, indicating the position they are applying for in the subject heading. Candidates must be authorized to work in the U.S. Can work remotely.
The Director of QA Good Clinical Practices (GCP) will be responsible for all aspects of Quality Assurance GCP activities to ensure quality assurance and compliance of Denovo sponsored clinical trials with applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH GCP guidelines, Denovo Standard Operating Procedures (SOPs), and current industry standards and practices. Activities will generally fall under the following areas: GCP QA audit program, Denovo quality systems, and internal/clinical study team support. The Director, QA GCP will establish, maintain, and ensure effectiveness of quality programs and documentation to assure GCP compliance and inspection readiness.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
Education, Certifications, Experience
Knowledge, Skills, and Abilities
Please note these job descriptions are not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Denovo Biopharma is a privately held biotech company using a novel biomarker solution to personalize drug development. We acquire drugs which have failed Phase 2/Phase 3 clinical trials, discover novel biomarkers, and reenter late-stage trials. The core technology of the company is its industry's first platform and algorithm to perform de novo genomic biomarker discovery retrospectively using archived clinical samples. This technology is especially useful for late stage clinical drugs that have completed trials with unsatisfactory efficacy or side effect. By identifying biomarkers correlated to patients' responsiveness to drug candidates retrospectively, our technology enables biotech and pharmaceutical companies to design new clinical trials in targeted patient population to achieve higher efficacy and/or less adverse effects. Our platform can be broadly applied to biomarker discovery in most therapeutic areas, such as oncology and neurological diseases. Our pipeline is filled with first-in-class drugs from Big Pharma that we are applying our biomarker discovery approach to. Our lead compound is Enzastaurin, an oncology drug acquired from Eli Lilly. It is in a global biomarker-guided Phase 3 pivotal study for first-line DLBCL using genetic biomarkers that Denovo successfully discovered. We have also discovered a novel genetic biomarker for our drug liafensine, for treatment-resistant depression, and plan on starting a Phase 2b study using it this year. Additional we have six other late-stage drugs that are in earlier stages of biomarker discovery.
We are looking for entrepreneurs who will thrive in our collaborative environment and share our mission to change the future of medicine.