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 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.

As a global company, our comprehensive benefits may vary based on location.  We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

For USA based roles:

Financial & Rewards  

• 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  

Health & Well-Being  

• 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  

Skill Development & Career Paths: 

• 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