Director, Clinical Operations

Summary

Join QED Therapeutics, a BridgeBio Pharma affiliate, as their Director of Clinical Operations. This role focuses on operational excellence, ensuring GCP compliance, and optimizing clinical processes. You will contribute to standardized procedures, data visualization, and AI integration. The Director will also support the Chief Clinical Operations Officer on corporate initiatives and training. This fully remote position, preferably based in the San Francisco Bay Area, requires extensive experience in clinical operations within the biopharma industry. BridgeBio offers a competitive compensation and benefits package, including flexible PTO and opportunities for career advancement.

Requirements

• BA /BS required in a scientific/medical field
• At least 15 years of experience in clinical operations within the biopharma industry including leadership positions at the Director level
• Intimate knowledge of GCP and strong working knowledge in FDA, Good Clinical Practices and ICH regulations and guidelines and the application to the conduct of clinical trials
• Experience in Quality Assurance, SOP writing, CAPA preparation and successful closure
• Excellent leadership, organizational and multi-tasking skills in a fast-paced start-up environment
• Dynamic and energetic, hands-on approach to the challenges. Independent and proactive with an eye to strategy
• Excellent written and verbal skills and strong interpersonal skills required
• Fully remote position - preferably based in the San Francisco Bay Area

Responsibilities

• Contribute to the development and maintenance of standardized clinical operations procedures, centralized data visualization tools, and leveraging AI while ensuring adherence to Good Clinical Practice (GCP) and regulatory requirements
• Point of contact for QA to update and standardize SOPs
• Engage with Medical Affairs and Patient Advocacy on conference coordination and attendance
• Attend and support monthly QA/Clin Ops meetings
• Support the creation, deployment, and management of Clinical Operations’ systems, process and procedures, training programs, GCP compliance, and regulatory inspection-readiness activities
• Lead the development, review and revision and deployment of Clinical Operations’ Policies, Quality Standards and Standard Operating Procedures in accordance with ICH/GCP guidelines and company policies to ensure inspection readiness
• Work closely with the VP of Clinical Operations on Inspection Readiness initiatives, coordination and implementation
• Lead QED Clinical Operations department meetings, training initiatives and teambuilding activities
• Assist Clinical Operations Study Leads with responses to audit findings from Site and Vendor audits
• Participate in Inspection Readiness Core Team meetings and discussions
• Evaluate Clinical Operations initiatives across BridgeBio Affiliates related continuous improvement processes and quality standards related to operational excellence
• Support coordination of quarterly All BridgeBio Affiliate Clinical Operations Meetings for training purposes and process alignment

Preferred Qualifications

• Advanced degree preferred
• Experience with rare disease studies and patient advocacy preferred

Benefits

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
• An unyielding commitment to always putting patients first
• A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• A place where you own the vision – both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion