Sr. Clinical Trial Manager

About Eidos Therapeutics & BridgeBio Pharma

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a Phase 3 developmental-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our investigational product, acoramidis (AG10), is an orally administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

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, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe. 

To learn more about our story and company culture, visit us at eidostx.com/ | https://bridgebio.com

Who You Are

The Senior Clinical Trial Manager is responsible for the execution and management of assigned clinical studies while ensuring Good Clinical Practices (GCP) Compliance, high study quality, and timely completion. This position is responsible for assisting in meeting functional, organizational, and corporate goals for acoramidis (AG10) by providing successful management of clinical study teams and clinical trials.

Responsibilities

• Leads the Clinical Study Team for assigned projects; may lead one or more clinical studies, from concept to protocol, and achieve corporate objectives and key milestones such as First Patient In, Interim Analysis, Database lock, etc.
• Manage external vendors and contract research organizations, may manage internal resources such as Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs)
• Prepare/Review/Approve study documents such as the Monitoring Manual, Study Operational Manual, Source Data Verifications Plan, and Laboratory Manual
• Coordinate and design study materials such as CRFs, patient diaries, study participation cards, and source documents
• Assist with protocol development and study report completion
• Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to GCP, Standard Operating Procedures (SOPs), and study protocols
• Provide guidance, direction, and management to CRAs
• Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in the coordination of data management activities
• Coordinate study supplies
• Negotiate and manage contracts
• Review Informed Consent Forms, CRFs, and study-related materials
• Plan and participate in investigator meetings
• Assist and support the data query process
• 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 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

Education, Experience & Skills Requirements

• Bachelor’s degree in a scientific discipline or equivalent is required, and an advanced degree is preferred
• Requires at least eight years of biopharma industry experience (relevant clinical trials experience, in the biotechnology, pharmaceutical, CRO, medical device industry) with at least two years managing clinical trials
• Must have vendor management experience in clin