Senior Safety Scientist

Location
San Francisco, California
Posted
Jul 04, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract
Eidos Therapeutics, a subsidiary 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 finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas, including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh with small satellites in other parts of the country. 

To learn more, visit us at  eidostx.com/ www.bridgebio.com

Who You Are:

The Senior Safety Scientist 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


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)
  • 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 enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so


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