Sr. Director/Safety Scientist, Pharmacovigilance Operations

BridgeBio Pharma

2d•Remote

About The Position

Sr. Director/Safety Scientist, Pharmacovigilance Operations Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here—but if it sparks excitement…read on. In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask “why not?” and help reengineer the future of biopharma. Affiliate Overview ML Bio, an affiliate within BridgeBio Pharma, is developing BBP-418 (ribitol), an investigational oral therapy for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), a rare genetic neuromuscular disease caused by mutations in the FKRP gene. BBP-418 is designed to address the underlying disease biology by supplying ribitol to support proper glycosylation of α-dystroglycan, which is critical for muscle integrity and function. The program has received Orphan Drug Designation from the U.S. Food and Drug Administration and the European Medicines Agency, as well as Fast Track and Rare Pediatric Disease Designations from the U.S. FDA. Topline interim results from the Phase 3 FORTIFY study have been publicly reported and support the ongoing clinical development of BBP-418. BBP-418 continues to be evaluated in global registrational clinical studies with the intent to bring a potential therapy to patients affected by this serious rare disease. What You’ll Do Oversight and understanding of all aspects of the assigned product’s safety profile from clinical development to post-approval safety surveillance, including management of CROs and other partners that provide clinical and safety data Facilitate Safety Management Committee for designated product(s), responsible for identifying any emerging safety trends, defining the safety profile, and recommending safety actions based upon cumulative safety data In collaboration with the regulatory and clinical development team, establish the safety strategy for marketing authorization applications, including the preparation of CTD documents, engagement with regulatory authorities, and authoring responses to inquiries Where You’ll Work This is a U.S.-based remote role that will generally require up to three visits per year, or as needed, to our San Francisco office. Rewarding Those Who Make the Mission Possible We have high expectations for our team members and ensure that those working hard for patients are rewarded and supported. Financial Benefits Market-leading compensation 401(k) with 100% employer match on the first 3% and 50% match on the next 2% Employee stock purchase program Pre-tax commuter benefits Referral program with a $2,500 award for hired referrals Health & Wellbeing Comprehensive health coverage with 100% of premiums covered for employees and dependents Mental health support via Spring Health (6 therapy sessions and 6 coaching sessions) Hybrid work model with flexibility in where and how work is performed Unlimited flexible paid time off Paid parental leave: 4 months for birthing parents and 2 months for non-birthing parents Flexible spending accounts and company-provided group term life and disability insurance Subsidized lunches via Forkable on in-office days Skill Development & Career Paths Opportunities for growth from discovery through late-stage development and FDA pipelines Career pathing through regular feedback, professional development programs, and continuous education via LinkedIn Learning, LifeLabs, Spring Health, and BetterUp Coaching Recognition of strong performance through financial rewards, peer recognition, and advancement opportunities #LI-NT1 At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.

Requirements

Bachelor’s degree in a healthcare discipline or equivalent is required; an advanced degree is preferred
Minimum of ten years of drug safety and pharmacovigilance experience, including at least five years in clinical development safety
Extensive experience with all aspects of safety signal evaluation, including data review and analysis, cross-functional collaboration, authoring regulatory correspondence, and safety label updates
Experience in both clinical development and post-marketing safety
Intimate knowledge of GCP and strong working knowledge of FDA regulations, ICH guidelines, and global pharmacovigilance requirements
Proven ability to collaborate successfully with clinical trial teams, including data management, clinical sciences, medical monitoring, clinical operations, biostatistics, regulatory affairs, medical writing, and quality assurance
Experience managing clinical safety aspects of product quality defect investigations and assessments
Familiarity with clinical trial safety databases and CIOMS II and DSUR reporting (e.g., Argus, ArisG, or Veeva Safety) and proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Project, Outlook)

Nice To Haves

Experience with regulatory submissions for NDAs, EU MAAs, and other global regulatory reviews is highly preferred
Experience in drug safety audits and regulatory agency inspections

Responsibilities

Support the clinical development team in the review of key documents, including protocols and informed consent forms (ICFs)
Manage drug safety contract research organizations (CROs) for clinical programs to ensure compliance with expedited reporting requirements, on-time and scientifically sound DSUR preparation, and alignment with corporate goals and KPIs
Assist in the medical review of adverse event reports; manage preparation and submission of expedited safety reports in compliance with global regulations, when necessary
Develop and prepare assessments of safety data, safety signals, and benefit-risk evaluations for internal senior management as well as external partners and regulatory authorities
Assist in the authoring of aggregate safety reports

Benefits

Market-leading compensation
401(k) with 100% employer match on the first 3% and 50% match on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with a $2,500 award for hired referrals
Comprehensive health coverage with 100% of premiums covered for employees and dependents
Mental health support via Spring Health (6 therapy sessions and 6 coaching sessions)
Hybrid work model with flexibility in where and how work is performed
Unlimited flexible paid time off
Paid parental leave: 4 months for birthing parents and 2 months for non-birthing parents
Flexible spending accounts and company-provided group term life and disability insurance
Subsidized lunches via Forkable on in-office days
Opportunities for growth from discovery through late-stage development and FDA pipelines
Career pathing through regular feedback, professional development programs, and continuous education via LinkedIn Learning, LifeLabs, Spring Health, and BetterUp Coaching
Recognition of strong performance through financial rewards, peer recognition, and advancement opportunities