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.
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 clinical operations/development
Strong verbal and written communication skills, can communicate strategic direction and relevant context so that employees at all levels understand their role in achieving success
Ability to build and maintain strong working relationships within the department and cross- functionally to meet a project or corporate goal
Experience with Microsoft Office Suite required (Word, Excel, Project, Outlook)
Must be able and willing to travel periodically
Salary
$1 - $2 USD
As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
For USA based roles:
Financial & Rewards
Market-leading compensation
401(k) with employer match
Employee Stock Purchase Program (ESPP)
Pre-tax commuter benefits (transit and parking)
Referral bonus for hired candidates
Subsidized lunch and parking on in-office days
Health & Well-Being
100% employer-paid medical, dental, and vision premiums for you and your dependents
Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
Fertility & family-forming benefits
Expanded mental health support (therapy and coaching resources)
Hybrid work model with flexibili
Benefits
Health insuranceDental insuranceVision insurance401(k)Remote work optionsFlexible scheduleEquity / stock optionsPerformance bonus
Additional Information
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.
Bridgebio · Remote