Sr. Director, Drug Safety

About Eidos Therapeutics & BridgeBio Pharma

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a Phase 3 developmental-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our investigational product, acoramidis (AG10), is an orally administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs. 

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe. 

To learn more about our story and company culture, visit us at eidostx.com/ | https://bridgebio.com

Who You Are

BridgeBio is expanding commercial operations across the US and worldwide to support the launch of our asset in ATTR-CM. As part of that expansion, we are hiring a Senior Director of Drug Safety, who will be responsible for managing all aspects of the drug safety functions related to postmarketing surveillance, BridgeBio partner organizations, and will be an integral member of the Safety Management Team.  You will maintain strategic partnerships, oversee postmarketing safety compliance, and be a subject matter expert during agency inspections. In addition, you will be responsible for collaborating with Clinical Operations, QA, Clinical Research, Regulatory Affairs, and Medical Affairs to determine safety strategy for postmarketing.

Responsibilities

• The primary responsibilities are to maintain a collaborative and complaint relationship with business partners and postmarket safety vendor oversight and compliance
• Manage the drug safety relationship with business partners and safety vendors with >=95% compliance with safety data exchange agreements and maintain collaborative working relationships to meet corporate goals and key performance indicators  
• Oversee contract service organizations (CSOs) for postmarket programs to achieve corporate goals and key performance indicators  
• Establish postmarket pharmacovigilance systems for data exchange, signal management, and audit readiness  
• Develop and prepare assessments of global safety data, signal management, and benefits/risks with business partners and business partner data and analyses for internal senior management as well as external partner or regulatory authorities  
• Manages, maintains, and fulfills safety data exchange agreements and PV agreements
• Acts as the strategic partner safety liaison to facilitate timely collection of information from partners for signal management meetings and other meetings, and maintain audit trail as inspection ready at all times of data exchanged   
• Oversees partner liaison aspects of global periodic safety review, signal management, and ICSR exchange    
• Accountable for partner liaison aspects of the quality management system for signal management (GVP Module IX.B.5) and PBRER preparation   
• Supports ad hoc safety review meetings, including all internal and external stakeholders, with compliance with signal evaluation timelines, and maintain a