BridgeBio Pharma
Biopharma
R&DMDVP
Neural analysis suggests this role is
optimal for Executive candidates.
“R&D MD VP at BridgeBio Pharma. Skills: Drug safety, Pharmacovigilance, Risk management. Manage drug safety functions. Collaborate with Clinical Operations”
What You'll Achieve.
Develop life-changing medicines; Achieve the impossible
Industry & Context.
Solve problems
Quarterly visits to San Francisco Office, As needed visits to San Francisco Office
What They're Looking For.
Must Have
MD, DO or international equivalent, 12 years industry experience, 9 years senior drug safety experience, Experience in clinical development, Experience in post-marketing drug safety, Regulatory Submission experience, 1-3 years project leadership experience, Safety experience in multiple therapeutic areas, Completion of US residency or ex-US equivalent
Nice to Have
Experience writing safety sections of marketing applications, DSUR/PSUR experience preferred, Management Experience preferred
What You'll Do.
Manage drug safety functions
Collaborate with Clinical Operations
Collaborate with Clinical Research
Collaborate with Regulatory Affairs
Collaborate with Medical Information/Liaisons
Collaborate with Medical Writing
Contribute to pharmacovigilance activities
Lead pharmacovigilance activities
Manage operational activities
Manage cross-functional activities
Manage quality systems
Direct drug safety management oversight
Manage oversight of external vendor activities
Oversee case processing
Oversee expedited safety reporting
Oversee partner data exchange
Lead safety operations strategy
Lead case management strategy
Lead database strategy
Lead vendor oversight strategy
Lead compliance strategy
Lead inspection readiness strategy
Lead contracts strategy
Lead training strategy
Lead Safety section of submission documents
Participate in presentations with Regulatory Authorities
Lead presentations with Regulatory Authorities
Participate in meetings with consultants
Lead meetings with consultants
Participate in meetings with investigators
Lead meetings with investigators
Participate in advisory panel meetings
Lead advisory panel meetings
Contribute to safety data exchange agreements
Review safety data exchange agreements
Contribute to safety management documentation
Review safety management documentation
Develop risk management strategies
Provide updates of safety profile
Recommend pharmacovigilance activities
Recommend risk management activities
Contribute to investigator’s brochures
Review investigator’s brochures
Contribute to safety sections of protocols
Review safety sections of protocols
Contribute to single expedited reports
Review single expedited reports
Contribute to aggregate expedited reports
Review aggregate expedited reports
Contribute to regulatory submissions
Review regulatory responses
Plan pharmacovigilance activities
Manage pharmacovigilance activities
Perform pharmacovigilance activities
Monitor pharmacovigilance activities
Monitor product safety profile
Develop product safety profile
Set-up safety analyses
Provide company causality assessments
Provide clinical input in signal detection
Perform signal evaluation activities
Provide clinical perspective at Safety Management Committee
Participate in Bridgebio Safety Board
Maintain currency with PV global regulations
Maintain currency with industry guidelines
Oversee preparation of SOPs
Oversee development of SOPs
Oversee implementation of SOPs
Oversee maintenance of SOPs
Oversee preparation of policies
Oversee development of policies
Oversee implementation of policies
Oversee maintenance of policies
Contribute to inspection readiness activities
Develop strategies to enhance Drug Safety department
Develop strategies to optimize Drug Safety department
Develop strategies to enhance PV department
Develop strategies to optimize PV department
How You'll Work.
Team & Collaboration
Cross-functional teams; Safety Management Team; Alliance partners
Communication Scope
Excellent communication; Interpersonal skills; Presentations; Reporting
Process & Methodology
Project leadership
Full Job Description
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. Who You Are The VP of Drug Safety will be responsible for managing all aspects of the drug safety functions of the CROs and will be an integral part of the Safety Management Team. In addition, they will be responsible for collaborating with Clinical Operations, QA, Clinical Research, Regulatory Affairs, Medical Information/Liaisons, and Medical Writing for investigational compounds across the company. Responsibilities can grow to include marketed product safety and pharmacovigilance when appropriate. Responsibilities Contribute to and lead a full range of pharmacovigilance (PV) activities for investigational products, including operational activities, cross-functional activities with other departments, quality systems, audits, and inspections Direct drug safety management oversight (clinical study case process flow, reconciliation with clinical database) for specific clinical trials, as requested Manage oversight of external activities by vendors (CR
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