Precision Point Staffing ™ · 1 day ago
Clinical Pharmacologist
Precision Point Staffing is representing a pulmonology focused biopharmaceutical company developing therapies for respiratory and pulmonary diseases. They are seeking a Clinical Pharmacologist to lead and support clinical pharmacology strategy across pulmonary programs including dose selection PK PD and exposure response analyses to enable informed decision making throughout clinical development.
Responsibilities
Lead clinical pharmacology strategy for pulmonary and respiratory drug development programs
Design and interpret PK PD and exposure response analyses to support dose selection and regimen optimization
Support inhaled and or systemic respiratory therapies including small molecules biologics or combination products
Provide input into early phase and late stage study design including SAD MAD and proof of concept trials
Author and review clinical pharmacology sections of protocols IBs INDs and regulatory submissions
Collaborate cross functionally with clinical development translational medicine biostatistics regulatory and CMC teams
Support regulatory agency interactions related to clinical pharmacology and dose justification
Evaluate special population considerations relevant to pulmonology such as pediatrics smokers and patients with compromised lung function
Qualification
Required
PhD PharmD or MD in Clinical Pharmacology Pharmaceutical Sciences or a related discipline
Experience supporting clinical pharmacology in pulmonology or respiratory disease programs
Strong knowledge of PK PD modeling exposure response and dose justification
Experience contributing to regulatory submissions and cross functional development teams
Ability to clearly communicate quantitative concepts to clinical and non clinical stakeholders
Preferred
Experience with pulmonary delivery systems
Hands on experience with population PK modeling tools such as NONMEM Monolix or similar
Experience supporting asthma COPD IPF PAH or other respiratory indications
Prior experience in biotech or pharma environments with fast paced development timelines
Company
Precision Point Staffing ™
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