Sr. Medical Director, Drug Safety & Pharmacovigilance

About Eidos Therapeutics & BridgeBio Pharma

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a commercial 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. Attruby (acoramdis) is an orally administered small molecule designed to stabilize TTR, a 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

An experienced safety physician who will lead the postmarketing safety strategy for your assigned products, working closely with highly motivated colleagues eager to bring safe, new treatments to patients.  This role requires a keen ability to work collaboratively, adapt and find solutions to complex problems, and drive results.  You will be responsible for comprehensive oversight and strategic oversight of core safety information and local labeling, postmarketing safety data review, benefit-risk assessment, and risk management, and be a subject matter expert during agency inspections.

Responsibilities

The Sr. Medical Director is responsible for the overall risk management and safety strategy of assigned products, including both internal and external engagement with key collaborators.     

• Oversight and understanding of 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 of 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
• Accountable for partner liaison aspects of signal management and risk management (GVP Modules)
• Supports ad hoc safety review meetings, including all internal and external stakeholders, with compliance with signal evaluation timelines, and maintains 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

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

• Patient Champions, who put patient