Sr. Director, Clinical Pharmacology & Pharmacometrics

Sr. Director, Clinical Pharmacology & Pharmacometrics

Reports to: Chief Development Officer

Location: Remote U.S. or On-site/Hybrid Palo Alto

About GondolaBio

GondolaBio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. GondolaBio is an independent sister company to BridgeBio, originally carved out in 2024 after securing $300M in private financing from external investors. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases.

The Role

You are an experienced clinical pharmacology and quantitative pharmacology leader with deep expertise in early clinical development and a strong track record of informing dose selection and development decisions for oligonucleotide therapies. You are comfortable setting strategy at the portfolio and program level while also rolling up your sleeves to execute in a small, fast-moving biotech environment, and you are energized by the opportunity to help build and shape clinical pharmacology and pharmacometrics approaches as the company and pipeline grow.

A successful candidate must have a demonstrated track-record of driving success in translational research, clinical pharmacology, MIDD and regulatory negotiations as an individual contributor and team leader in oligonucleotides. Key areas of emphasis will include but are not limited to clinical dose selection and refinement across all phases of clinical development, FIH and clinical pharmacology study design, development and hands-on application of MIDD using population and statistical framework, as well as mechanistic and translational PK/PD approaches.

Key Responsibilities

• Own the clinical pharmacology strategy and development plan for each program, from IND through NDA/MAA.

• Lead first-in-human dose selection and escalation, integrating nonclinical PK/PD, toxicology, and translational data.

• Personally perform and oversee translational and mechanistically based PK/PD modeling to enable identification of FIH dose, early characterization of efficacy and safety using biomarkers and disease animals.

• Lead and execute pharmacometrics strategies across all stages of drug development, including population PK, PK/PD, and exposure-response modeling and simulation, meta-analysis, disease modeling to inform clinical development.

• Support nonclinical PK/PD, ADME and DMPK evaluations including strategy development, data analysis and integration.

• Design and interpret clinical pharmacology studies and analyses, including renal/hepatic impairment, immunogenicity impact, and concentration-QTc strategy. Develop and execute pediatric dosing and extrapolation strategies appropriate to rare disease populations.

• Author and review clinical pharmacology content for regulatory documents: IND/CTA, Investigator’s Brochure, protocols, briefing packages, CSRs, and Module 2.7.2 summaries.

• Represent as functional area lead in FDA, EMA, and other health authority interactions, including starting dose rationale, dose escalation design, SAD/MAD strategy, and integration of nonclinical and translational data from IND to NDA/BLA.

• Encompass leading-edge knowledge in clinical pharmacology and pharmacometrics discipline, publish manuscripts. Advocate scientific leadership at external conferences and scientific community