Senior Director, Clinical Pharmacology

<div class="content-intro"><p><span style="text-decoration: underline;"><strong><span data-contrast="auto">Mavericks Wanted</span></strong><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></span></p> <p><span data-contrast="auto">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</span> <br><span data-contrast="auto"> </span> <br><span data-contrast="auto">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. </span> <br><span data-contrast="auto"> </span> <br><span data-contrast="auto">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.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></p></div><h3><u>What You'll Do</u></h3> <p>Senior Director, Clinical Pharmacology, leading clinical pharmacology and pharmacometrics strategies on cross-functional teams. This role will have oversight over the design and application of population PK, exposure–response, PK/PD, and PBPK models at various stages of the clinical drug development programs for predominantly small molecules. This role will also have oversight over external bioanalytical CROs. The position will also support 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.</p> <p> </p> <h3><u>Responsibilities</u></h3> <p>Develop and implement clinical pharmacology and pharmacometrics strategies across all stages of clinical development including pediatric development programs.</p> <p>Manage the design, development, and application of NCA, population PK, exposure–response, PK/PD, and PBPK models to inform decision-making across programs.</p> <p>Oversee modeling and simulation-based analyses to support dose selection and study design for clinical trials in pediatric populations, and support global regulatory submissions and labeling.</p> <p>Author and contribute to clinical pharmacology sections of regulatory documents (e.g., IB, DSUR, briefing books, NDA/MAA submissions) and support interactions with global regulatory agencies.</p> <p>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.</p> <p>Present results to internal teams and external stakeholders, including contributions to scientific publications, abstracts, and conference presentations.</p> <p> </p> <h3><u>Where You'll Work</u></h3> <p><em>This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco