Sr. Clinical Trial Manager/Associate Director, Clinical Operations

at  BridgeBio

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:

EDUCATION, EXPERIENCE & SKILLS REQUIREMENTS

• Bachelor’s required in a scientific/medical field. Advanced degree preferred
• Minimum eight years of experience in Clinical Operations, working with CROs and other vendors at all stages of development within the biopharma industry
• At least five years of management experience in a clinical research environment
• Experience in rare / orphan disease and pediatric studies preferred
• Experience in maintenance of a submission ready eTMF required
• Previous experience working in a cross-functional environment
• History of successfully developing effective relationships with outside vendors and CROs
• Outstanding verbal communication skills, which resulted in professionally communicating and guiding individual and team efforts related to Clinical Operations
• Demonstrated skills in negotiation, multi-tasking, organization, and decision-making
• Proficiency in databases, coding, and data mining methodologies as well as Microsoft applications
• Strong knowledge of GCP and working knowledge in ICH
• Knowledge of GDPR and how to apply appropriate practices to clinical trials
• Ability to travel to regional and global sites

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.
• 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
  At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
  Salary

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 advises management team of potential problems 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
• Monitor global regulatory intelligence for international industry practices for operational efficiency and compliance
• Responsible for operational guidance for investigators and providing 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 addressing issues raised by CROs or other service providers
• Participate in the conduct of audits and support regulatory inspections related to GCP
• Address consistency in the collection, processing, and evaluation of clinical data
• Coordinate and plan for availability of clinical and non-clinical supplies required for trial execution
• Contribute to the development of ClinOps SOPs and company policies to ensure compliance with regional regulatory requirements and drive continuous improvements
• Represent Clinical Operations on cross-functional teams

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