R&D MD VP

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 (CROs), including case processing, expedited safety reporting, and partner data exchange. The successful candidate will be responsible for oversight of safety operations strategy, including case management, database strategy, vendor oversight, compliance, inspection readiness, contracts, and training
• Lead Safety section of submission documents
• Participate and/or lead presentations with Regulatory Authorities
• Participate and/or lead meetings with consultants and investigators
• Participate and/or lead advisory panel meetings
• Contribute to and review safety data exchange agreements with alliance partners and safety management documentation for studies managed under an alliance, as applicable
• Develop proactive risk management strategies for investigational compounds
• Provide updates of the assigned drug’s safety profile to senior management and recommend pharmacovigilance/risk management activities
• Contribute to and review investigator’s brochures, safety sections of clinical study protocols, single and aggregate expedited reports, areas of regulatory submissions, or regulatory responses (including IRBs or Ethics Committees)
• Plan, manage/perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including:
  • Continuous monitoring and further development of the product safety profile
  • Safety issue management
  • Set-up of safety analyses in both clinical trial and post-marketing databases
• Provide company causality assessments
• Provide clinical input in signal detection and perform signal evaluation activities
• Provide a clinical (drug safety) perspective at Safety Management Committee meetings
• Participate in Bridgebio Safety Board when requested
• Maintain currency with applicable PV global regulations and industry guidelines
• Oversee preparation, development, implementation, and maintenance of company standard operating procedures and policies relating to pharmacovigilance and risk management to ensure compliance with ICH guidelines and applicable regulatory requirements
• Contribute to inspection readiness activities
• Develop strategies to further enhance and optimize the impact of the Drug Safety and PV department

Education, Experience & Skills Requirements

• Post-graduate degree (MD, DO) or international equivalent from an accredited institution
• Excellent communication and interpersonal skills
• Minimum of 12 years of relevant industry experience, which includes at least 9 years of senior drug safety experience
• Must have experience in both clinical development and post-marketing drug safety
• Must have Regulatory Submission experience
• Minimum of One (1) to three (3) years of project leadership/management experience
• Experience writing safety sections of marketing applications, integrated safety summary, DSUR/PSUR preferred
• Excellent and broad understanding of the pharmaceutical industry and the future trends and developments in pharmacovigilance
• Management Experience preferred
• Must have safety experience in multiple therapeutic areas
• Completion of a US residency or ex-US equivalent

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.