Senior Clinical Trial Manager

Full-TimeQEDAny Office LocationClinical Operations

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QED Therapeutics, a subsidiary of BridgeBio Services, 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 finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh, with small satellites in other parts of the country. 

To learn more, 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.
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
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 enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so
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-TimeQEDAny Office LocationClinical Operations

Apply Now