Senior Director, Clinical Pharmacology – Pharmacometrics

GondolaBio

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

Posted 10/20/2026full-timeRemote • California • United StatesSenior💰 $285,000 - $325,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in clinical pharmacology strategy and development, including hands-on experience with pharmacometrics, modeling, and regulatory submissions. Proven ability to lead complex clinical studies and communicate findings effectively to diverse audiences.

Highest-signal resume keywords

PhD In Pharmacometrics10+ Years Clinical Pharmacology ExperienceModeling And Simulation ExpertiseRegulatory Submission AuthoringPediatric Development Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacokineticsPharmacodynamicsPopulation PK ModelingExposure-Response ModelingNONMEMRPhoenixPBPK ModelingQSP ModelingDisease Progression Modeling

Soft Skills

Collaborative CommunicationScientific Leadership

Industry Keywords

INDNDAMAAOligonucleotide TherapeuticsIntrathecal ASOCNS PharmacokineticsNeurologyNeuromuscular DisordersRare DiseasesHealth Authority Interactions

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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