BlossomHill Therapeutics, Inc. · 5 hours ago
Director, Clinical Pharmacology
San Diego, CA
Full-time
Onsite
Lead/Staff, Director/Executive
5+ years expBlossomHill Therapeutics, Inc. is seeking a Director of Clinical Pharmacology to lead clinical pharmacology activities in drug development programs. The role involves applying model-informed drug development approaches, designing clinical studies, and collaborating with interdisciplinary teams to enhance drug development efficiency and success rates.
BiopharmaBiotechnologyHealth CareOncologyPharmaceuticalTherapeutics
Responsibilities
Act as clinical pharmacology lead in study teams and provide clinical pharmacology expertise to study design, data analysis and interpretation, and overseeing clinical pharmacology studies by working with CROs
Responsible for conducting non-compartmental analysis of human clinical PK data, and PK and PK/PD analyses including population PK, PK/PD and Exposure/response modeling and simulation, and meta-analysis
Provide the clinical pharmacology components of Clinical Development Plans, IBs, and regulatory documents such as INDs, Briefing documents, responses to regulatory queries, etc
Design, author and/or review clinical (pharmacology) study protocols, including PK/PD, drug-drug interaction (DDI), bioavailability, and first-in-human studies, and support the execution of clinical trials when applicable, conduct pharmacometrics analyses, and incorporate findings into study report and regulatory documents as well as participate directly in regulatory interactions
Provide Clinical Pharmacology expertise to discovery team during the pre-clinical stages of drug development and works with research colleagues to ensure quantitative mechanistic understanding of preclinical PK-PD data to inform human administration
Develop a MIDD strategy that integrates nonclinical data, quantitative understanding of the relationship among dose, PK, PD, efficacy and safety endpoints in the context of heterogeneous diseases (e.g., biomarkers), patient populations (e.g., intrinsic and extrinsic factors) and competitive landscape to make go/no go decisions, support dose and dosing regimen selection, and optimize preclinical and clinical study designs (sample size, duration, endpoints) throughout drug discovery and development
Qualification
Required
Ph.D. or PharmD or equivalent in life sciences, pharmaceutical sciences or related field
5 to 10 years of related experience
Strong hands-on experience with pharmacometrics software (e.g., NONMEM, Monolix, Phoenix WinNonlin, R)
Understanding of drug development in oncology or other therapeutic areas
Excellent analytical and problem-solving skills, with the ability to interpret complex data and translate findings into actionable drug development strategies
Excellent interpersonal, leadership, communication and time-management skills are essential
Company
BlossomHill Therapeutics, Inc.
BlossomHill Therapeutics, Inc.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$257MKey Investors
Colt Ventures
2025-12-10Series B· $84M
2024-01-02Series B· $100M
2023-01-01Series Unknown
Leadership Team
Y. Peter Li
Co-Founder
Recent News
BioWorld Financial Watch
2026-01-03
Venture Capital
2025-12-20
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