Senior Director, Clinical Pharmacology – Pharmacometrics

🕒 Yesterday

🏄 California – Remote

🏄 California – Remote

💵 $285k - $325k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 4%

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GondolaBio

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2024

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 $300M Venture Round - GondolaBio on 2024-08

Healthcare • Consulting • Manufacturing

GondolaBio is a clinical-stage biopharmaceutical company launched in 2024 and affiliated with BridgeBio Pharma, focused on developing breakthrough therapeutics for patients with genetic diseases. The company uses a lean, decentralized approach to accelerate early-stage research and development across multiple modalities (including small molecules and oligonucleotide therapies) and is building a diverse pipeline targeting rare and underserved genetic conditions such as EPP/XLP with its lead program PORT-77. GondolaBio centers patient needs and aims to bring disease-modifying treatments more quickly to populations lacking approved therapies.

📋 Description

• Own the clinical pharmacology strategy and development plan for each program from IND through NDA/MAA • Lead first-in-human dose selection and escalation using nonclinical PK/PD, toxicology, and translational data • Perform and oversee translational and mechanistically based PK/PD modeling • Lead pharmacometrics strategies including population PK, PK/PD, exposure-response modeling and simulation, meta-analysis, and disease modeling • Support nonclinical PK/PD, ADME, and DMPK evaluations • 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 for rare disease populations • Author and review clinical pharmacology content for regulatory documents, including IND/CTA, Investigator’s Brochure, protocols, briefing packages, CSRs, and Module 2.7.2 summaries • Represent the functional area in FDA, EMA, and other health authority interactions • Provide starting-dose rationale, dose-escalation design, SAD/MAD strategy, and integration of nonclinical and translational data from IND to NDA/BLA • Publish manuscripts and provide scientific leadership at external conferences and in the scientific community • Report to the Chief Development Officer

🎯 Requirements

• PhD in Pharmacometrics, Quantitative & Clinical Pharmacology, Pharmaceutical sciences, or a related field • 10+ years of industry clinical pharmacology and/or pharmacometrics experience, with increasing leadership responsibility • Hands-on clinical pharmacology experience supporting programs from first-in-human into later-stage clinical development, ideally including novel modalities • Demonstrated hands-on modeling and simulation expertise, such as NONMEM, R, and Phoenix • Track record authoring clinical pharmacology sections of regulatory submissions and supporting health authority interactions • Experience in a small or fast-paced biotech environment • Clinical pharmacology experience with oligonucleotide therapeutics, strongly preferred • Intrathecal ASO experience and CNS/CSF pharmacokinetics • Neurology, neuromuscular, or rare disease experience • Pediatric development and extrapolation experience • Registration experience (NDA/MAA) and participation in late-stage regulatory meetings • PBPK, QSP, and disease progression modeling experience • Clear, collaborative communication and ability to translate quantitative findings for clinical and executive audiences

🏖️ Benefits

• Annual bonus • Equity • Comprehensive benefits package • Patient Days • Access to learning and development resources • Flexible PTO • Decentralized model with decision-making power close to the science • Collaborative, fast-paced, data-driven environment • Career ownership and development opportunities