BridgeBio · 2 months ago
Sr. Director Clinical Pharmacology
United States
Full-time
Remote
Director/Executive
10+ years expBridgeBio is a biotechnology company focused on developing life-changing medicines for patients with unmet needs. The Sr. Director of Clinical Pharmacology will lead pharmacometric and clinical pharmacology strategies for global pediatric drug development programs, overseeing model applications and regulatory submissions while communicating findings to stakeholders.
BiotechnologyHealthcareLife SciencePharmaceuticalHealth CareMedical
Responsibilities
Develop and implement clinical pharmacology and pharmacometrics strategies to support global pediatric drug development programs
Manage the design, development, and application of population PK, exposure–response, PK/PD, and PBPK models to inform decision-making across programs
Conduct model-informed analyses to support study design, dose selection, and optimization of efficacy and safety for Phase 2 and Phase 3 trials in pediatric populations (0–18 years), and support regulatory submissions and labeling
Author and contribute to clinical pharmacology sections of regulatory documents (e.g., IB, DSUR, briefing books, NDA/MAA submissions) and support interactions with regulatory agencies (FDA, EMA, PMDA, etc)
Design clinical pharmacology studies and manage study execution and CROs/vendors. Conduct PK data analyses, provide study-level oversight, including authoring, review, and approval of protocols, analysis plans, and reports
Apply quantitative analytical tools to support early development decisions, including clinical candidate selection and first-in-human (FIH) study design (e.g., PK/PD modeling, human PK projections, and dose/exposure selection)
Present results to internal teams and external stakeholders, including contributions to scientific publications, abstracts, and conference presentations
Qualification
Required
Ph.D. or Pharm.D. in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, or a related discipline, with 10+ years of relevant experience in the biotechnology or pharmaceutical industry (or equivalent combination of education and experience)
Demonstrated track record of hands-on modeling and simulation (M&S) across drug development, including experience supporting regulatory submissions; experience in pediatric drug development is preferred
Expertise in population PK, PK/PD, mechanistic modeling (e.g., PBPK), and quantitative data analysis, with a proven ability to apply these approaches to inform clinical development and regulatory strategy
Proficiency in industry-standard pharmacometrics tools and programming languages (e.g., NONMEM, Monolix, NLME, Simcyp, R)
Strong understanding of global regulatory expectations and guidance (e.g., FDA, EMA) related to clinical pharmacology and model-informed drug development (MIDD)
Excellent analytical, critical thinking, and problem-solving skills, with the ability to translate complex quantitative findings into clear, actionable insights
Strong written, verbal, and interpersonal communication skills, with experience presenting to internal teams and external stakeholders
Preferred
Experience in pediatric drug development is preferred
Benefits
401(k) with employer match
Employee Stock Purchase Program (ESPP)
Pre-tax commuter benefits (transit and parking)
Referral bonus for hired candidates
Subsidized lunch and parking on in-office days
100% employer-paid medical, dental, and vision premiums for you and your dependents
Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
Fertility & family-forming benefits
Expanded mental health support (therapy and coaching resources)
Hybrid work model with flexibility
Flexible, “take-what-you-need” paid time off and company-paid holidays
Comprehensive paid medical and parental leave to care for yourself and your family
People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
We celebrate strong performance with 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.
501-1000 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
36%
Represents job field similar to this job
Engineering and Development
Management and Executive
Legal and Compliance
Customer Service and Support
Accounting and Finance
Trends of Total Sponsorships
*2026 (3)
2025 (3)
2024 (5)
2023 (4)
2022 (4)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$5.9BKey Investors
Sixth StreetBlue OwlQatar Investment Authority
2026-07-01Post Ipo Equity· $1B
2026-01-16Post Ipo Debt· $550M
2025-02-25Post Ipo Debt· $500M
Leadership Team
Justin To
CEO, Skeletal Dysplasias (QED Therapeutics)
Neil Kumar
CEO and Founder
Recent News
2026-07-10
Investor's Business Daily
2026-07-10
2026-07-10
Company data provided by crunchbase