Director, Clinical Operations

About QED Therapeutics & BridgeBio Pharma

QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families.
 
Our business is inspired by our values:

• PUT PATIENTS FIRST
• LET SCIENCE SPEAK
• EVERY MINUTE COUNTS
• THINK INDEPENDENTLY
• BE RADICALLY TRANSPARENT

FGFR=fibroblast growth factor receptor.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, Raleigh, and with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, visit us at https://www.qedtx.com/ | https://bridgebio.com 

Who You Are

This role in Clinical Operations is focused on QED operational excellence, key performance indicators (KPIs) for inspection readiness, clinical quality assurance, optimization of clinical processes and systems, training programs, and standard operating procedures (SOPs) to ensure GCP compliance and inspection readiness within Clinical Operations.  

The Director will also support the Chief Clinical Operations Officer on the development of corporate initiatives, monthly team meetings, professional department training and evaluate initiatives across BridgeBio Affiliates.

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

No matter your role at BridgeBio, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors, who execute against goals and milestones with quality, precision, and speed

Education, Experience & Skills Requirements

• BA/BS required in a scientific/medical field. Advanced degree preferred
• At least 15 years of experience in clinical operations within the biopharma industry including leadership positions at the Director level
• Experience with rare disease studies and patient advocacy preferred
• 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  

What We Offer

• 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. Learn more about how we do this here
• 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