What are the responsibilities and job description for the Clinical Trial Manager position at BridgeBio Pharma, Inc.?
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, TRUSELTIQ (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 [ Link removed ] - Click here to apply to Clinical Trial Manager | [ Link removed ] - Click here to apply to Clinical Trial Manager
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 accountable 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 ensure 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
No matter your role at BridgeBio, successful team members are:
Patient Champions, who put patients first and uphold strict ethical standardsEntrepreneurial Operators, who drive toward practical solutions and have an ownership mindsetTruth Seekers, who are detailed, rational, and humble problem solversIndividuals Who Inspire Excellence in themselves and those around themHigh-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 advanced degree is preferred
* Prefer at least five years of biopharma industry experience (relevant clinical trials experience in the biotechnology, pharmaceutical, CRO, and medical device industry) with at least one-year managing clinical trials
* Must have vendor management experience in clinical operations/development
* The global trial, pediatric, orphan drug, and/or rare disease knowledge is preferred
* 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
* Must be able and willing to travel periodically
* 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 - with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels seen, valued, and heard
To view San Francisco County's Fair Chance Ordinance, please click here.
QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on precision medicine for FGFR-driven cancers and diseases. The company's first therapy, TRUSELTIQ (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 [ Link removed ] - Click here to apply to Clinical Trial Manager | [ Link removed ] - Click here to apply to Clinical Trial Manager
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 accountable 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 ensure 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
No matter your role at BridgeBio, successful team members are:
Patient Champions, who put patients first and uphold strict ethical standardsEntrepreneurial Operators, who drive toward practical solutions and have an ownership mindsetTruth Seekers, who are detailed, rational, and humble problem solversIndividuals Who Inspire Excellence in themselves and those around themHigh-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 advanced degree is preferred
* Prefer at least five years of biopharma industry experience (relevant clinical trials experience in the biotechnology, pharmaceutical, CRO, and medical device industry) with at least one-year managing clinical trials
* Must have vendor management experience in clinical operations/development
* The global trial, pediatric, orphan drug, and/or rare disease knowledge is preferred
* 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
* Must be able and willing to travel periodically
* 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 - with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels seen, valued, and heard
To view San Francisco County's Fair Chance Ordinance, please click here.
Recommended Skills
- Biotechnology
- Clinical Trials
- Clinical Works
- Customer Service
- Databases
- Decision Making
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