Clinical Trial Manager

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

The Clinical Trial Manager is responsible for the execution and management of assigned clinical studies while ensuring GCP Compliance, high study quality and timely completion. This position is responsible for meeting functional, organizational, and corporate goals by successfully managing clinical trials. 

Responsibilities

• May lead one or more regions or clinical studies, from concept to protocol, and through the achievement of corporate objectives and key milestones such as First Patient In, Interim Analysis, Database lock, CSR, etc 
• Manage external vendors and Contract Research Organizations (CROs) in study start-up, conduct, and close-out 
• Oversee CRO clinical monitoring activities (may include oversight visits of CRO clinical monitoring visits) at clinical sites to assure adherence to protocol, GCPs, and SOPs. Review monitoring visit reports 
• Oversee specimen tracking, tracking of subject visits to support various study analyses, and timely data review to identify trends and discrepancies 
• Assist with site feasibility, site selection, and country/site-start-up activities 
• Prepare / Review / Approve study documents such as the Monitoring Plan, ICFs, CRFs, Pharmacy Manual and Laboratory Manual 
• Assist with protocol development and study report completion  
• Oversee coordination of study supplies  
• Review study and site budgets and vendor/CRO invoices 
• Participate in Investigator Meetings  
• Ensures Trial Master File is current and maintained 
• Assist and support data query process  

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

• Bachelor’s degree in a scientific discipline or equivalent is required, and an advance degree is preferred
• Prefer at least 5 years of biopharma industry experience (relevant clinical trials experience, in the biotechnology, pharmaceutical, CRO, medical device industry) with at least 1 year managing clinical trials
• Must have vendor management experience in clinical operations/development
• Global trial, pediatric, orphan drug and/or rare disease knowledge is preferred
• Knowledge of clinical trial documentation and regulatory requirements related to trial master files 
• Strong verbal and written communication skills, can communicate strategic direction and relevant context so that team members at all levels understand their role in achieving success
• Ability to build and maintain strong working relationships within the department, cross-functionally, with clinical sites, vendors and CROs to meet a project or corporate goal
• Demonstrates skills in negotiation, multi-tasking, organization, and decision making
• Proactively identifies problems and generates possible solutions to present to a team 
• Structured and organized with excellent attention to detail 
• Ability to communicate and collaborate respectfully in a remote environment 
• Must be able and willing to travel on a periodic basis
• Experience with Microsoft Office Suite required (Word, Excel, Project, Outlook)

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