Director/Sr. Director Clinical Pharmacology

The role

This person will lead pharmacometric and clinical pharmacology strategies across global pediatric drug development programs. They will oversee the design and application of various models to inform dose selection, study design, and optimization of efficacy and safety.

What you will do

• Develop and implement clinical pharmacology and pharmacometrics strategies for global pediatric drug development programs.
• Manage the design, development, and application of population PK, exposure–response, PK/PD, and PBPK models.
• Conduct model-informed analyses to support study design, dose selection, and optimization of efficacy and safety for Phase 2 and Phase 3 trials.
• Author and contribute to clinical pharmacology sections of regulatory documents.
• Support interactions with regulatory agencies like FDA, EMA, and PMDA.
• Design clinical pharmacology studies and manage study execution and CROs/vendors.
• Conduct PK data analyses and provide study-level oversight.
• Apply quantitative analytical tools to support early development decisions.
• Present results to internal teams and external stakeholders.

Required qualifications

• Ph.D. or Pharm.D. in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, or a related discipline
• 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
• Experience supporting regulatory submissions
• Expertise in population PK, PK/PD, mechanistic modeling (e.g., PBPK), and quantitative data analysis
• 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
• Strong written, verbal, and interpersonal communication skills

Nice to have

• experience in pediatric drug development

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
• Flexible Spending Accounts (FSA)
• Fertility & family-forming benefits
• Expanded mental health support (therapy and coaching resources)
• Hybrid work model with flexibility

About the company

BridgeBio uses a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella. They build bridges to groundbreaking advancements in rare disease and develop medicines for patients with unmet needs.