Senior Clinical Pharmacologist (Sr. Scientist)
CorMedix Therapeutics
1 month ago
Remote
United States
$162,000 - $175,000 USD yearly
Clinical Research and Development
Senior Clinical Pharmacologist (Sr. Scientist) — Clinical Pharmacology
Key Responsibilities
- Perform, review, and interpret pharmacokinetic (PK) analyses, including non-compartmental and model-informed approaches
- Support the design, execution, and analysis of clinical pharmacology studies in humans
- Contribute to the development and refinement of study protocols, with emphasis on PK-related sections
- Prepare and review clinical pharmacology content for key clinical and regulatory documents (e.g., clinical study reports, regulatory submission modules, and FDA briefing materials)
- Collaborate with cross-functional teams to address PK-related questions and support timely delivery of outputs
- Interface with external CROs and pharmacometrics partners, managing contracts, reviewing outputs, and ensuring quality of deliverables
- Interpret clinical pharmacology data to inform program-level and dose-selection decisions
- Apply relevant regulatory guidance to ensure analyses and reporting are compliant, consistent, and scientifically rigorous
Experience / Qualifications
- 1–2 years of relevant industry experience (postdoctoral experience may be considered)
- Experience performing and interpreting noncompartmental pharmacokinetic (NCA) analyses
- Experience authoring PK study reports
- Experience developing, evaluating, and interpreting population pharmacokinetic (PopPK) models, with familiarity with FDA PopPK guidance and regulatory standards
- Experience supporting clinical study execution
- Experience collaborating with cross-functional teams (Clinical Ops, Regulatory, CMC) and/or external partners/CROs
Preferred Experience
- Experience in antibiotic development
- Proficiency in data analysis and population PK modeling using tools such as R, NONMEM, WinNonlin, or related platforms
Education
- PhD or PharmD with focus in Pharmacokinetics, Pharmacology, Pharmaceutical Sciences, or a closely related field
- Strong foundation in clinical pharmacology principles, PK, and study design
Work Location / Schedule
- Fully remote with flexibility to work from home
- Occasional in-person collaboration at headquarters in Parsippany, New Jersey
Key Responsibilities
- Perform, review, and interpret pharmacokinetic (PK) analyses, including non-compartmental and model-informed approaches
- Support the design, execution, and analysis of clinical pharmacology studies in humans
- Contribute to the development and refinement of study protocols, with emphasis on PK-related sections
- Prepare and review clinical pharmacology content for key clinical and regulatory documents (e.g., clinical study reports, regulatory submission modules, and FDA briefing materials)
- Collaborate with cross-functional teams to address PK-related questions and support timely delivery of outputs
- Interface with external CROs and pharmacometrics partners, managing contracts, reviewing outputs, and ensuring quality of deliverables
- Interpret clinical pharmacology data to inform program-level and dose-selection decisions
- Apply relevant regulatory guidance to ensure analyses and reporting are compliant, consistent, and scientifically rigorous
Experience / Qualifications
- 1–2 years of relevant industry experience (postdoctoral experience may be considered)
- Experience performing and interpreting noncompartmental pharmacokinetic (NCA) analyses
- Experience authoring PK study reports
- Experience developing, evaluating, and interpreting population pharmacokinetic (PopPK) models, with familiarity with FDA PopPK guidance and regulatory standards
- Experience supporting clinical study execution
- Experience collaborating with cross-functional teams (Clinical Ops, Regulatory, CMC) and/or external partners/CROs
Preferred Experience
- Experience in antibiotic development
- Proficiency in data analysis and population PK modeling using tools such as R, NONMEM, WinNonlin, or related platforms
Education
- PhD or PharmD with focus in Pharmacokinetics, Pharmacology, Pharmaceutical Sciences, or a closely related field
- Strong foundation in clinical pharmacology principles, PK, and study design
Work Location / Schedule
- Fully remote with flexibility to work from home
- Occasional in-person collaboration at headquarters in Parsippany, New Jersey