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 audit trail as inspection ready at all times
• Develops and prepares reports for company management as well as external regulatory agencies
• Ensure compliance with standard operating procedures and clinical trial and post-market global drug safety regulations, including to the FDA, EMA, MHRA, and all assigned international RAs
• Implement pharmacovigilance SOPs and ensure the uniform and timely processing of adverse event data in all assigned development and post-marketing programs
• When requested, work with other BridgeBio Affiliates to provide strategic input and work on assigned non-product/compound-related projects

No matter your role at BridgeBio, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors, who execute against goals and milestones with quality, precision, and speed

Education, Experience & Skills Requirements

• Bachelor's degree in a health care discipline or equivalent is required, and an advanced degree is preferred

• Requires at least 12 years of drug safety and pharmacovigilance experience (post-market 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)

• Preferred skill sets:

• All phases of development and marketed compounds

• Worked/presented to FDA and international regulatory authorities

• US and global submission experience

• Leading teams - especially SMCs or equivalents

• Worked in multiple therapeutic areas

• Experience in both clinical trial and post-marketing safety required

• Experience with management of business partner safety SDEAs with at least 3 years of maintenance of ongoing partner relationships or equivalent

• Experience with safety aspects of clinical trials

• Experience with Regulatory submissions for PSUR, PBRER, RMP, and other countries' Regulatory reviews; experience in US, EU Canada, Brazil, Australia preferred

• Direct FDA and EMA, but also other regulatory bodies (e.g. Anvisa, Health Canada...) inspection experience

• Demonstrated ability to successfully manage drug safety team or drug safety CRO for clinical and post-marketing programs with responsibilities for ICSR collection, expedited reporting, on-time PSUR preparation, and meeting corporate goals and key performance indicators

• Safety signal management, and tracking, including supporting regulatory documentation

• Experience in drug safety audits and agency inspections as case processing, PSUR, and CSO management subject matter expert

• Intimate knowledge of GCP and strong working knowledge of FDA or other agencies, Good Clinical Practices, and ICH regulations and guidelines

• Experience in working with clinical trial and post-marketing teams, including data management, clinical sciences, medical monitors, clinical operations, biostats, regulatory, medical writing, medical liaisons, call center, QA, and business partners

• Management of compliance deviations and formulations of CAPAs

• Experience establishing and maintaining post-marketing signal management systems, inspection experience required

• Familiar with clinical trial safety database use and CIOMS II and PSUR reporting generation (Argus, ArisG, or VeevaSafety) and Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook)

• Must be able and willing to travel

What We Offer

• 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. Learn more about how we do this here
• 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