Applicants who meet one of our vacant position designation criteria should send their resume to hr@denovobiopharma.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.

Position Summary

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

• Work collaboratively with internal Clinical Operations Team to ensure compliance standards are achieved.
• Manage the GCP Quality interface and support for all Project Teams.
• Identify and access compliance risk areas and develop and implement risk mitigation measures.
• Manage GCP audit program to include routine and non-routine quality assurance audits of clinical investigator sites, vendors, processes, systems and study documents to ensure integrity and accuracy of study data and assure quality compliance with internal procedures as well as regulatory guidelines.
• Review and approve Clinical SOPs.
• Develop and Implement Clinical QA SOPs.
• Develop and Implement detailed audit plans and yearly GCP audit schedules.
• Ensure the timely and effective follow up of all identified or assigned quality issues.
• Conduct QA oversight of GCP protocols, ICFs, CSRs and other clinical trial specific documents as requested.
• Direct or perform CSR audits and eTMF audits.
• Prepare written audit reports and communicate findings and recommendations and evaluate the adequacy and completeness of corrective and preventative action plans.
• Direct and/or deliver yearly GCP training for internal staff.
• Work closely with Clinical Development, Clinical Operations, Biometrics, PV/Safety and other departments to ensure compliance readiness.
• Provide leadership in inspection preparedness to Denovo clinical sites, GCP and GCLP vendors for BIMO inspections and inspections by other regulatory government agencies.
• Provide management reports on audit strategy, plans, findings, and product complaint trends.
• Support process improvement initiatives; Lead continuous process improvements within Quality.
• Maintain required knowledge of applicable regulations, guidelines and company standards and procedures.

JOB QUALIFICATIONS

Education, Certifications, Experience

• Bachelor’s Degree or advanced degree in a scientific discipline; Quality assurance professional certification is a plus.
• Minimum of 10+ years’ current work experience in pharmaceutical industry Quality Assurance required.
• Demonstrated Quality Management System experience (GCP specific QMS experience preferred).
• Demonstrated Issue Management and CAPA experience in a clinical environment.
• Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs.
• Strong leadership with demonstrated ability to interface with senior leaders and different levels of organization.

Knowledge, Skills, and Abilities

• Solid understanding of GCP and ICH clinical requirements.
• Excellent written/oral communication skills and interpersonal skills to build key networks and business relationships across all levels of the business.
• Attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents.
• A self-starter and a team-player who thrives in a fast-paced dynamic team environment.
• Knowledge of Microsoft Office applications, Adobe, DocuSign, and Veeva.
• Experienced working with EDC, IRT, eTMF, EMR systems.

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.