Associate Director/Director, Drug Safety

Location
San Francisco, California
Posted
Oct 02, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract
About Eidos Therapeutics & BridgeBio Pharma

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a clinical-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 product candidate, 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, Boston, New York, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, 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:

The Associate Director/Director, Drug Safety will be responsible for managing all aspects of the drug safety functions of the CSOs and will be an integral part of the Safety Management Team. In addition, you will be responsible for collaborating with Clinical Operations, QA, Clinical Research, Medical Writing.  

Responsibilities:
  • Manage the drug safety expedited reporting, manage on-time and scientifically sound DSUR preparation, and ensure the drug safety functions of the CSOs meet corporate goals and key performance indicators
  • Manages the drug safety CSOs for scalable and high-quality SAE case processing for growth over the clinical program and into postmarketing
  • Manages the drug safety CSOs for compliance tracking for all safety submissions across all  drug safety functions of the CSOs  
  • Manages and reconciles drug safety data to and from the Clinical Events Committee for blinded trials
  • Reviews protocols, ICFs, and other documents requested by Clinical Research, Clinical Operations, Medical Writing, QA
  • Works with data management in the ongoing reconciliation of clinical and safety databases
  • Assists in the medical review of severe adverse event reports
  • Assists in the data reviews and medical analysis for internal Safety Management Committee (VP and C-suite level scientists), DMCs, DSURs, IBs, CSRs, CSR SAE narratives, CCSIs, product labeling, RMPs, new drug application safety updates, and other reports as necessary
  • Acts as a liaison with external collaborators to develop processes to meet regulatory reporting requirements
  • Develops and prepares reports for company management as well as external regulatory agencies
  • Ensure compliance with standard operating procedures and clinical trial and postmarket global drug safety regulations, including to the FDA, EMA, MHRA, other RAs
  • Implement pharmacovigilance SOPs and ensure the uniform and timely processing of adverse event data in all assigned development and postmarketing programs
  • Manage the drug safety contract service organizations (CSOs) for clinical programs with >=95% compliance with expedited reporting, manage on-time and scientifically sound DSUR preparation, and ensure the drug safety functions of the CSOs meet corporate goals and key performance indicators
  • 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 towards 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 five 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)
  • Team member needed for Drug Safety and Pharmacovigilance department
  • EU MAA submission experience – including QPPV service management, PSMF experience, EMA inspection experience for new approvals
  • Growing a clinical trial drug safety system into a global post marketing PV system
  • Demonstrated ability to successfully manage drug safety team or drug safety CSO for a clinical program with responsibilities for  expedited reporting, on-time DSUR preparation, and meeting corporate goals and key performance indicators
  • Experience working on a cross-functional team leading to the delivery of the Safety section of an NDA, BLA, or other crucial regulatory filings
  • Experience  in drug safety audits and agency inspections as case processing, DSUR, and CSO management subject matter expert
  • Intimate knowledge of GCP and strong working knowledge in FDA, Good Clinical Practices and ICH regulations and guidelines, and the demonstrated ability to manage drug safety and pharmacovigilance regulatory requirements during the conduct of 2 or more clinical trials
  • Experience in working with clinical trial teams, including data management, clinical sciences, medical monitors, clinical operations, biostats, regulatory, medical writing, and QA
  • Experience with drug safety and clinical trial aspects of clinical trial design, protocol development and review, CRF and SAE Form preparation, and site initiation visit safety reporting slide preparation and training
  • Must be able and willing to travel periodically
  • Familiar with clinical trial safety database use and CIOMS II and DSUR reporting generation (Argus, ArisG, or VeevaSafety) and Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook)


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 – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels seen, valued, and heard


We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.