Sr. Director, Clinical Pharmacology & Pharmacometrics

GondolaBio Service Co, Inc.; Palo Alto (CA); Hybrid; USD 285,000 - 325,000; Full time

Benefits offered by this job

Equity and comprehensive benefits

Flexible PTO

Job summary

GondolaBio seeks a Sr. Director, Clinical Pharmacology & Pharmacometrics to lead dose selection and translational PK/PD for oligonucleotide programs in a remote U.S. or on-site/hybrid Palo Alto setting. You will shape portfolio strategy and MIDD approaches in a fast-paced biotech environment.

The role requires a PhD and 10+ years in clinical pharmacology/pharmacometrics, with hands-on modeling and regulatory submission experience, plus strong cross-functional leadership and communication skills.

Qualifications

• 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.
• Hands-on modeling and simulation using NONMEM, R, Phoenix.
• Track record authoring clinical pharmacology sections of regulatory submissions.
• Experience in a small or fast-paced biotech environment; both strategist and individual contributor.
• Clear, collaborative communicator for clinical and executive audiences.

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.
• Perform translational and mechanistically based PK/PD modeling to enable FIH dose and early efficacy/safety insights.
• Lead pharmacometrics strategies across all stages: population PK, PK/PD, exposure–response, meta-analysis, disease modeling.
• Support nonclinical PK/PD, ADME and DMPK evaluations with data analysis and integration.
• Design and interpret clinical pharmacology studies, including pediatric dosing and extrapolation in rare diseases.
• Author/review regulatory documents: IND/CTA, ICFs, protocols, CSRs, Module 2.7.2 summaries.
• Represent functional area in FDA/EMA interactions, including start-dose rationale and SAD/MAD strategy.

Skills

Clinical pharmacology leadership

Modeling & simulation

Regulatory submissions

Clear communication

Independent contributor

Education

PhD in Pharmacology/Pharmacometrics/Pharmaceutical sciences

Tools

NONMEM

R

Phoenix

Job description

Job Description

Description:

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

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 (e.g., NONMEM, R, Phoenix) and the ability to do the work, not only oversee it.
• Track record authoring clinical pharmacology sections of regulatory submissions and supporting health authority interactions.
• Experience in a small or fast-paced biotech environment; comfortable being both strategist and individual contributor.
• Clear, collaborative communicator who can translate quantitative findings for clinical and executive audiences.

Preferred Qualifications

• Clinical pharmacology experience with oligonucleotide therapeutics (ASO, conjugated-siRNA,), strongly preferred.
• Intrathecal ASO experience and CNS/CSF pharmacokinetics.
• Neurology, neuromuscular, or rare disease experience (e.g., hereditary peripheral neuropathies, myotonic dystrophy).
• Pediatric development and extrapolation experience.
• Registration experience (NDA/MAA) and participation in late-stage regulatory meetings.
• PBPK, QSP and disease progression modeling experience.

No matter your role at GondolaBio, successful team members are

• Patient Champions who put patients first, uphold strict ethical standards, and anchor decisions in clinical and scientific integrity.
• Entrepreneurial Operators who take ownership and drive toward practical solutions, while exercising sound judgment, respecting established processes, and aligning with teammates and leadership.
• Truth Seekers who are rigorous, detail-oriented, and intellectually honest - comfortable challenging assumptions, engaging with data, and updating their views based on evidence.
• Collaborative Thinkers who work effectively in data-driven, interdisciplinary environments; listen actively; and welcome questions, debate, and constructive challenge as essential to better decision-making.
• Individuals Who Inspire Excellence in themselves and those around them.
• High-quality Executors who deliver against goals and milestones with precision, accountability, and appropriate urgency - without compromising scientific rigor or team alignment.

What We Offer

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
• An unyielding commitment to always putting patients first
• A decentralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• A place where you own the vision - both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Flexible PTO

Compensation & Benefits

The anticipated base salary range for this role is $285,000 to $325,000, plus annual bonus, equity, and a comprehensive benefits package. Final compensation depends on experience, qualifications, and level.

GondolaBio ServiceCo is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Employees of BridgeBio and all affiliated companies should work through their managers to inquire about and learn more about this role.