Director/Sr. Director Clinical Pharmacology

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. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work. What You'll Do Director/Senior Director, Clinical Pharmacology, leads pharmacometric and clinical pharmacology strategies across global pediatric drug development programs and serves as the Clinical Pharmacology lead on cross-functional teams, translating complex quantitative insights into actionable development decisions. This role oversees the design and application of population PK, PK/PD, exposure–response, and PBPK models to inform dose selection, study design, and optimization of efficacy and safety across Phase 2 and Phase 3 trials. The position also supports regulatory strategy by authoring key clinical pharmacology documents and contributing to interactions with global health authorities, while effectively communicating findings to internal and external stakeholders. 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. Where You'll Work This is a U.S.-based remote role that may require quarterly or as-needed visits to our San Francisco Office. Who You Are 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 pharmac…