BridgeBio · 1 day ago
Sr. Director, Scientist
United States
Full-time
Remote
Director/Executive
$262K/yr - $370K/yr
10+ years expBridgeBio is a pioneering biotech company focused on developing life-changing medicines for patients with unmet needs. The Sr. Director, Scientist will oversee all aspects of product safety from clinical development to post-approval safety surveillance, while collaborating with regulatory and clinical teams to establish safety strategies.
BiotechnologyHealth CareLife ScienceMedicalPharmaceutical
Responsibilities
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
Support the clinical development team in the review of key documents, including protocol and ICFs
Manage the drug safety contract service organizations (CROs) for clinical programs to ensure compliance with expedited reporting, manage on-time and scientifically sound DSUR preparation, and ensure the drug safety functions of the CROs 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, when necessary
Develop and prepare assessments of safety data, safety signals, and benefit/risk for internal senior management as well as external partner or regulatory authorities
Assist in the authoring of aggregate reports
Qualification
Required
Bachelor's degree in a health care discipline or equivalent is required
At least ten years of drug safety and pharmacovigilance experience with at least 5 years experience in Clinical Development Safety
Extensive experience with all aspects of safety signal evaluation, including review and analysis of data, collaboration with cross-functional team members and senior management, authoring of required regulatory correspondence, and safety label updates
Experience in both clinical development and post-marketing safety
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)
Preferred
Advanced degree is preferred
Experience with Regulatory submissions for NDAs, EU MAAs, and other countries' Regulatory reviews is highly preferred
Benefits
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with $2,500 award for hired referrals
Comprehensive health care with 100% premiums covered - no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model - employees have the autonomy in where and how they do their work
Unlimited flexible paid time off - take the time that you need
Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
Flex spending accounts & company-provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
Financial rewards, peer-to-peer recognition, and growth opportunities
Company
BridgeBio
BridgeBio focuses on the development and commercialization of precision medicines for various genetic diseases and cancers.
201-500 employees
H1B Sponsorship
BridgeBio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
2023 (4)
2022 (4)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$4.35BKey Investors
Blue OwlQatar Investment AuthorityKohlberg Kravis Roberts
2025-02-25Post Ipo Debt· $500M
2024-03-04Post Ipo Equity· $250M
2024-01-18Post Ipo Debt· $1.25B
Leadership Team
Justin To
CEO, Skeletal Dysplasias (QED Therapeutics)
Neil Kumar
CEO and Founder
Recent News
2026-01-05
2025-12-24
Company data provided by crunchbase