Senior Clinical Trial Manager

Full-TimeQEDSan Francisco Bay AreaClinical Operations

Apply Now

About QED Therapeutics & BridgeBio Pharma

QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on precision medicine for FGFR-driven cancers and diseases. The company’s first therapy, TRUSELTIQTM (infigratinib), is an orally administered FGFR1-3 tyrosine kinase inhibitor that the US FDA recently approved to treat patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement. We are also evaluating infigratinib for the treatment of other FGFR-driven cancers and the treatment of achondroplasia and other skeletal dysplasias.

QED is derived from the Latin “Quod Erat Demonstrandum” —Thus; It Has Been Proven. 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, Boston, New York, and Raleigh, 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 Senior Clinical Trial Manager (Sr. CTM) is responsible for managing the operational activities of assigned clinical programs. This individual role provides a level of expertise aligned with the principles and standard practices for operating activities of clinical trials QED Therapeutics. Act as the lead for assigned projects and provide regional insight to global projects where applicable. Responsible for CRO oversight, training, vendor management, and review of agreements related to CRO clinical activities. Partner with key stakeholders - internal and external - to ensure continuous harmonized operations of clinical operations activities and maintain high standards for functioning in a cross-functional environment.  Global trial experience is a plus. This position is remote and can be located anywhere in the United States.
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 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
  • Monitors global regulatory intelligence for international 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 towards 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
  • Minimum 8 years of experience in Clinical Operations, working with CROs and other vendors
  • At least five years of management experience in a clinical research environment
  • 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 we 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 – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels seen, valued, and heard

  • #Li-Remote
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.
careers

Senior Clinical Trial Manager

Full-TimeQEDSan Francisco Bay AreaClinical Operations

Apply Now