About the role

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
 
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 
 
Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

What You'll Do

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.
Manage operational activities at the study level and 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
Negotiate and mange vendor work agreements an site contracts

Where You'll Work

This is a U.S.based remote role that will require quarterly, or as needed visits to our San Francisco Office.

Who You Are

Historically the "Experience, Education, & Skills Requirement" section

(5-7 bullets max)

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 clinical operations/development
Strong verbal and written communication skills, can communicate strategic direc

Skills & Tags

go gcp ai ios data design

Aplyr's read

BridgeBio Pharma is a dynamic biotechnology firm dedicated to tackling genetic diseases and cancers, attracting professionals passionate about impactful medical advancements.
Synthesized from recent postings & public sources

What's promising

•BridgeBio focuses on innovative treatments for genetic diseases, offering significant potential for groundbreaking medical advancements.
•The company has a robust pipeline with multiple late-stage clinical trials, indicating strong future growth prospects.
•BridgeBio's strategic partnerships enhance its research capabilities and expand its therapeutic reach.

What to watch

•The company faces high financial risk due to significant R&D expenditures without guaranteed success.
•BridgeBio operates in a highly competitive market with numerous established players.
•Regulatory hurdles for drug approvals can delay product launches and impact revenue.

Why BridgeBio Pharma

•BridgeBio's focus on genetic diseases and cancers sets it apart in the biotechnology sector.
•The company's decentralized model allows for nimble and efficient project management.
•BridgeBio's commitment to rare diseases addresses unmet medical needs, differentiating its mission.

Aplyr’s read is generated by AI from public sources. Was it useful?