BridgeBio Pharma
Clinical Research Associate San Francisco, CA/Hybrid
BridgeBio Pharma, Palo Alto, California, United States, 94306
QED San Francisco, CA/Hybrid Clinical OperationsAbout QED Therapeutics & BridgeBio PharmaQED 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 FIRSTEVERY MINUTE COUNTSTHINK INDEPENDENTLYBE RADICALLY TRANSPARENTFGFR=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.The Clinical Research Associate collaborates within the Clinical Operations team to support the timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials. Responsible for performing quality study oversight processes, including but not limited to monitoring, communications with clinical site staff, in addition to clinical vendors and clinical vendor Monitors, and review monitoring trip reports. In addition, participate in the training, oversight of clinical vendor monitors and study site staff personnel, and development of standardized clinical oversight/tracking tools.Responsibilities
Work closely with the Senior Clinical Trial Manager to support all aspects of clinical studies from initiation, planning, execution, maintenance, and close-outTake a leadership role in the assigned site and study management activities, including ICFs, site activations, monitoring reports, and study plansAct as a bridge between QED and the Investigators/study sites and contribute to building solid sponsor-site relationshipsProvide oversight of contract vendors and Clinical Research Organization activities to ensure all are conducted according to study plans, timelines, budgets, relevant SOPs, and compliance with GCPs, FDA regulation, and ICH/GCP guidelinesProactively identify issues for escalation, participate in problem-solving and implementation of risk mitigationCoordinate and maintain relevant tracking systems for subject screening, enrollment, study visits, data entry, query resolution, and related metricsPerform co-monitoring visits with CRO, as needed, to provide oversight during site qualification, site initiation, routine monitoring, and close-out visitsParticipate in the development, review, and implementation of departmental SOPs and processesParticipate in the development of study-related clinical documents, including informed consent forms, site training materials, CRFs, clinical monitoring plans, source document templates, and data audit worksheetsAssist in the preparation of study protocols, I.B.s, and regulatory submissionsSupport the organization in maintaining a work environment focused on quality, fostering learning, respect, open communication, collaboration, integration, and teamworkAdditional operations activities may be assigned as appropriateTravel as required to carry out responsibilities (up to 20%)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 speedEducation, Experience & Skills Requirements
BSc in natural or health sciences (biology, pharmacology, pharmaceutical sciences, or equivalent) or relevant industry experience in lieuMinimum
4-6
years of experience within clinical operations, study coordinator, or similar field; Citi training preferredKnowledge of clinical trial documentation and regulatory requirements related to trial master files is preferredAbility to communicate and collaborate respectfully in a remote environmentEffective communication, interpersonal skills, and true team playerDecision-making abilities, but knows when to ask for adviceStructured and organized with excellent attention to detailProactively identifies problems and generates possible solutions to present to a teamEager to learn and balance multiple tasks simultaneouslyExcellent verbal and written communication skillsSuccess in working with CROs and vendorsExcellent communication skills and ability to achieve milestones in a team environmentExperience using M.S. Office Suite (Excel, Word, PowerPoint)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 effortsA culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speakAn unyielding commitment to always putting patients first. Learn more about how we do this
hereA 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 scienceA place where you own the vision – both for your program and your own career pathA collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our gameAccess to learning and development resources to help you get in the best professional shape of your lifeRobust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)Flexible PTORapid career advancement for strong performersPotential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over timeCommitment to Diversity, Equity & Inclusion
#J-18808-Ljbffr
Our business is inspired by our values:PUT PATIENTS FIRSTEVERY MINUTE COUNTSTHINK INDEPENDENTLYBE RADICALLY TRANSPARENTFGFR=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.The Clinical Research Associate collaborates within the Clinical Operations team to support the timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials. Responsible for performing quality study oversight processes, including but not limited to monitoring, communications with clinical site staff, in addition to clinical vendors and clinical vendor Monitors, and review monitoring trip reports. In addition, participate in the training, oversight of clinical vendor monitors and study site staff personnel, and development of standardized clinical oversight/tracking tools.Responsibilities
Work closely with the Senior Clinical Trial Manager to support all aspects of clinical studies from initiation, planning, execution, maintenance, and close-outTake a leadership role in the assigned site and study management activities, including ICFs, site activations, monitoring reports, and study plansAct as a bridge between QED and the Investigators/study sites and contribute to building solid sponsor-site relationshipsProvide oversight of contract vendors and Clinical Research Organization activities to ensure all are conducted according to study plans, timelines, budgets, relevant SOPs, and compliance with GCPs, FDA regulation, and ICH/GCP guidelinesProactively identify issues for escalation, participate in problem-solving and implementation of risk mitigationCoordinate and maintain relevant tracking systems for subject screening, enrollment, study visits, data entry, query resolution, and related metricsPerform co-monitoring visits with CRO, as needed, to provide oversight during site qualification, site initiation, routine monitoring, and close-out visitsParticipate in the development, review, and implementation of departmental SOPs and processesParticipate in the development of study-related clinical documents, including informed consent forms, site training materials, CRFs, clinical monitoring plans, source document templates, and data audit worksheetsAssist in the preparation of study protocols, I.B.s, and regulatory submissionsSupport the organization in maintaining a work environment focused on quality, fostering learning, respect, open communication, collaboration, integration, and teamworkAdditional operations activities may be assigned as appropriateTravel as required to carry out responsibilities (up to 20%)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 speedEducation, Experience & Skills Requirements
BSc in natural or health sciences (biology, pharmacology, pharmaceutical sciences, or equivalent) or relevant industry experience in lieuMinimum
4-6
years of experience within clinical operations, study coordinator, or similar field; Citi training preferredKnowledge of clinical trial documentation and regulatory requirements related to trial master files is preferredAbility to communicate and collaborate respectfully in a remote environmentEffective communication, interpersonal skills, and true team playerDecision-making abilities, but knows when to ask for adviceStructured and organized with excellent attention to detailProactively identifies problems and generates possible solutions to present to a teamEager to learn and balance multiple tasks simultaneouslyExcellent verbal and written communication skillsSuccess in working with CROs and vendorsExcellent communication skills and ability to achieve milestones in a team environmentExperience using M.S. Office Suite (Excel, Word, PowerPoint)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 effortsA culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speakAn unyielding commitment to always putting patients first. Learn more about how we do this
hereA 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 scienceA place where you own the vision – both for your program and your own career pathA collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our gameAccess to learning and development resources to help you get in the best professional shape of your lifeRobust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)Flexible PTORapid career advancement for strong performersPotential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over timeCommitment to Diversity, Equity & Inclusion
#J-18808-Ljbffr