Sr. Director/Safety Scientist, Pharmacovigilance Operations

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  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  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.  Who You Are  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  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  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)  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. Salary$247,800—$284,800 USD

BridgeBio Pharma (NASDAQ: BBIO) is a biopharmaceutical company dedicated to advancing a diverse pipeline of medicines that target genetic diseases. Founded in 2015, BridgeBio is committed to developing innovative therapies that address unmet medical needs in various rare and genetic diseases. With a focus on precision medicine and a patient-centered approach, BridgeBio is at the forefront of revolutionizing treatment options for individuals affected by genetic disorders.