Senior Medical Director, Drug Safety & Pharmacovigilance

Summary

Join Eidos Therapeutics, a BridgeBio Pharma affiliate, as a Senior Medical Director to lead the postmarketing safety strategy for assigned products. You will oversee all aspects of product safety, from clinical development to post-approval surveillance. Collaborate with cross-functional teams, regulatory agencies, and external partners to establish and execute safety strategies. This role demands extensive drug safety and pharmacovigilance experience, including managing safety teams and regulatory submissions. Eidos offers a competitive compensation and benefits package, including flexible PTO, robust health benefits, and opportunities for career advancement.

Requirements

• Have a Medical Degree
• Require at least 12 years of drug safety and pharmacovigilance experience (clinical trials safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO) with at least three years of oversight management experience (line management or CSO management)
• Have extensive experience with all aspects of safety signal evaluation, including data review and analysis, collaboration with cross-functional team members and senior management, authoring required regulatory correspondence, and safety label updates
• Have experience in both clinical development and post-marketing safety
• Have experience with Regulatory submissions for NDAs, EU MAAs, and other countries’ Regulatory reviews
• Demonstrate the ability to successfully manage drug safety team or drug safety CSO for a postmarketing program with responsibilities for expedited reporting, on-time PBRER preparation
• Have experience in drug safety audits and global agency inspections
• Have intimate knowledge of GCP and strong working knowledge of FDA, Good Clinical Practices, and ICH regulations and guidelines
• Prove the ability to collaborate successfully with postmarketing teams, including medical affairs, biostats, regulatory, medical writing, and QA
• Have experience in managing all postmarketing safety aspects of product quality defect investigations and assessments
• Manage compliance deviations and formulations of CAPAs
• Be familiar with clinical trial safety database use and CIOMS II and PBRER reporting generation (Argus, ArisG, or VeevaSafety) and Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook)
• Be able and willing to travel periodically for face-to-face engagements with regulatory authorities and occasional on-site meetings (if based remotely)

Responsibilities

• Be responsible for the overall risk management and safety strategy of assigned products, including both internal and external engagement with key collaborators
• Oversee and understand all aspects of the assigned product’s safety profile from clinical development to post-approval safety surveillance, including management of contract service organizations and partners that provide safety data
• Chair the Safety Management Committee for the designated product(s), responsible for identifying emerging safety trends, defining the safety profile, and recommending safety actions based on cumulative safety data
• In collaboration with regulatory, clinical development, medical affairs, and business partners, establish the safety strategy for postmarketing safety, core safety information, local labeling, safety reporting, benefit-risk evaluation, risk management, engagement with regulatory authorities, and authoring of responses to inquiries
• Participate in publication preparation and medical information material review
• Manage medical aspects of aggregate data analysis, presentation of medical analyses internally and to regulatory agencies as required, expedited case analyses, scientifically sound PBRER preparation, and ensure the signal management and risk management functions of the contract service organizations meet corporate goals and key performance indicators
• Assist in the medical review of adverse event reports, manage preparation and submission of drug safety expedited reporting in compliance with regulations
• Develop and present assessments of safety data, safety signals, benefits, and risks for internal senior management as well as external partner or regulatory authorities
• Assist in the authoring of aggregate reports
• Be accountable for partner liaison aspects of signal management and risk management (GVP Modules)
• Support ad hoc safety review meetings, including all internal and external stakeholders, with compliance with signal evaluation timelines, and maintain audit trail as inspection ready at all times
• When requested, work with other BridgeBio Affiliates to provide strategic input and work on assigned non-product/compound-related projects

Benefits

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
• An unyielding commitment to always putting patients first
• A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• A place where you own the vision – both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion