Senior Director of Clinical Quality Assurance
89bio is a clinical-stage biopharmaceutical company focused on rapidly advancing our lead product candidate, BIO89-100, through clinical development for the treatment of non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). BIO89-100 is a specifically engineered glycoPEGylated analog of the metabolic hormone, fibroblast growth factor 21 (FGF21).
In September of 2020, the Company announced positive topline results from its Phase 1b/2a trial with BIO89-100 in patients with nonalcoholic steatohepatitis (NASH) Click HERE for press release
We believe these successful proof of concept results validate our view we have a very promising and differentiated FGF21 program.
We have also recently initiated our Phase 2 proof of concept study in SHTG. SHTG is characterized by triglyceride levels ≥500 mg/dL, and is associated with an increased risk of NAFLD, NASH, and cardiovascular diseases, as well as acute pancreatitis. It is estimated that there are 2.5 million to 4 million patients in the US with triglyceride levels ≥500 mg/dL. BIO89-100 has the potential to be a differentiated treatment that can potentially lower triglyceride levels while also offering improvements in liver fat and other metabolic comorbidities.
89bio is headquartered in San Francisco with operations in Herzliya, Israel. The Company closed its upsized initial public raising a gross $97.6 million in November of 2019 and raised over $160 million in July and September of 2020.
The culture at 89bio will provide you the opportunity to:
- Have a tangible impact on patient's lives
- Enhance your experience in a dynamic global environment
- Partner/work with an experienced, smart team that excels in fast paced execution
89bio is a nimble, flexible, transparent and diverse culture that values inclusivity, collaboration, communication, and creativity; a well-funded company with an experienced, passionate team committed to developing innovative therapies.
Come join us and do the best work of your life.
Reporting to the Vice President of Quality Assurance, the Senior Director of Clinical Quality Assurance will be a key member of the NASH and SHTG core team and is responsible for partnering with Clinical Operations to ensure that quality and compliance are integrated into long term strategies and day to day operations. This role is instrumental in establishing, improving, and maintaining quality systems at 89bio and driving functional and cross-functional projects that embed continuous improvement principles across the company. These responsibilities involve key strategic clinical quality decisions and working closely with Clinical Operations, Clinical Development, CMC, Medical Affairs, Regulatory Affairs, CROs, CDMOs, Clinical Trial Sites, and laboratories. This role may have future leadership responsibilities in building out a team. The position requires 5% domestic and 5% international travel.
The position is currently remote but will be located in our San Francisco offices when conditions allow.
KEY DUTIES & RESPONSIBILITIES:
- Establish and maintain the 89bio GCP QA programs, policies, and procedures and ensure cGCP compliance of clinical trials
- Act as the primary business partner with internal organizations including Clinical Operations and Clinical Development
- Act as the primary contact for vendors, contract facilities, and contract service providers related to quality aspects of clinical trials
- Oversee and manage the auditing and qualification process for clinical trial vendors, suppliers and contract organizations and facilities
- Ensure compliance with applicable health authority regulations and guidelines for document management, TMF, and software used in GCP processes
- Responsible for writing and maintaining GCP SOPs and providing associated training
- Understanding and interpreting global regulatory agency policies and guidance and ensuring that 89bio adapts internal policies and procedures accordingly
- Accountable for the QA review of clinical trial documentation and documents submitted to regulatory agencies
- Responsible for inspection readiness related to GCP and is the primary liaison with Health Authorities and Partners during internal audits and Health Authority inspections
- Conducts audits at Clinical Trial Sites, and Contract Research Organizations to ensure the compliant conduct of 89bio Sponsored clinical trials
- Monitors and manages current and projected quality issues with escalation to 89bio management for any potential issues of significance
REQUIRED EDUCATION, SKILLS & EXPERIENCE
- Bachelor's degree in a scientific discipline (e.g., biology, chemistry, pharmacy)
- 12 years of relevant biotechnology experience including 3+ years in an applicable Quality senior leadership role
- 8 years of GCP Quality Assurance experience
- 5 years working with biologics
- Prior audit experience (audit certification preferred)
- Solid track record of compliance and successful audits including developing compliant SOPs and practices
- Experience in developing and maintaining QA systems
- Prior experience/in-depth knowledge of clinical quality assurance
- Experience working with CROs
- Deep knowledge and understanding of drug development process, global regulations, and interfacing related to GXP, and GCP authorities
- Successful collaboration and open and authentic communication in a diverse workplace; a record of strong partnerships with clinical development/operations
- Strong written and oral communication skills, strong skills in translating complex concepts across all levels of the organization
- Success working independently in a fast-moving start-up environment
- Reputation for incorporating strong analytical thinking in developing technical and/or business solutions to complex problems
- Proven track record of driving the successful completion of major programs and projects
- Comprehensive understanding and wide application of technical principles, theories, concepts, and techniques
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.