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 Sr. Clinical Trial Manager (Sr. CTM) is responsible for managing the operational activities of assigned hypochondroplasia clinical programs. This individual contributor role provides a level of expertise aligned with the principles and standard practices for operational activities of clinical trials at QED Therapeutics. As the acting lead for assigned projects, this role provides regional insight into global projects where applicable. This role is responsible for CRO oversight, training, vendor management, and review of agreements related to CRO clinical activities. The Sr. CTM will partner with key stakeholders – internal and external – to ensure continuous harmonized operations of clinical operations activities and to maintain high standards for functioning in a cross-functional environment.  Global trial experience is a plus.

Responsibilities

• Responsible for representing Clinical Operations (ClinOps) on cross-functional study teams and Vendor, CRO operational meetings and ensuring compliance with global operational standards and procedures
• Provides leadership for ClinOps related issues and advise management team of potential issues and solutions
• Responsible for the review and oversight of tasks in study monitoring plans for operations and all operational activities associated with clinical trials
• Responsible for ensuring that all components of the trial master file (TMF/eTMF) are up to date and accurate for QED assigned investigational trials
• Monitors global regulatory intelligence for global industry practices for operational efficiency and compliance
• Responsible for operational guidance for investigators and provide CRO training related to the study conduct
• Responsible for reviewing study budgets and master ICF templates for study start-up
• Responsible for managing queries for clinical studies from CROs and address issues raised by CROs or other service providers
• Participates in the conduct of audits and support regulatory inspections related to GCP
• Addresses consistency in the collection, processing, and evaluation of clinical data
• Contributes to the development of ClinOps SOPs and company policies to ensure compliance with regional regulatory requirements and drive continuous improvements
• Represents Clinical Operations on cross-functional teams
• Supports QED sponsored clinical trials and development programs

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 required in a scientific/medical field; advanced degree preferred
• 6-8 years of relevant experience in a clinical research environment managing day-to-day clinical trial operations
• History of successfully developing effective relationships with outside vendors and CROs
• Rare pediatric disease experience preferred
• Demonstrated skills in negotiation, multi-tasking, organization and decision making
• Forward thinking with effective communication that translates to a clear sense of direction for both the Clinical Operations and the cross functional team is essential
• Demonstrated leadership to drive results needed to achieve company goals 
• Ability to wear multiple hats including focusing on detailed day-to-day tasks without losing sight of the big picture
• Proactive self-starter with ability to work independently
• Proficiency in databases, coding, and data mining methodologies as well as Microsoft applications
• Ability to travel to regional and global sites
• Prior experience working in a start-up environment is a plus

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