Sr. Director Clinical Pharmacology
About The Position
BridgeBio, founded in 2015, employs a "moneyball for biotech" approach, pooling projects and early-stage research from academia under one financial umbrella to mitigate risk and foster innovation. This model empowers science and small expert teams to drive progress, building bridges to groundbreaking advancements in rare diseases and developing life-changing medicines for patients with unmet needs as rapidly as possible. The company values curiosity, experimentation, and the ethical use of AI to enhance work quality and speed. The Director/Senior Director, Clinical Pharmacology, will lead pharmacometric and clinical pharmacology strategies for global pediatric drug development programs. This role involves serving as the Clinical Pharmacology lead on cross-functional teams, translating complex quantitative insights into actionable development decisions. Key responsibilities include overseeing the design and application of population PK, PK/PD, exposure–response, and PBPK models to inform dose selection, study design, and optimize efficacy and safety across Phase 2 and Phase 3 trials. The position also supports regulatory strategy by authoring essential clinical pharmacology documents and engaging with global health authorities, while effectively communicating findings to both internal and external stakeholders.
Requirements
- 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.
- 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.
Nice To Haves
- Experience in pediatric drug development is preferred.
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.
Benefits
- Market-leading compensation
- 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
- Opportunities for skill development and internal mobility
- Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
- Financial rewards, peer-to-peer recognition, and growth opportunities for strong performance
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
