Senior Clinical Pharmacologist (Sr. Scientist)

Job Title: Senior Clinical Pharmacologist (Sr. Scientist)
Type: Perm
Compensation: $150,000.00 - $165,000 depending on experience
Contractor Work Model: Remote but must be within EST time zone and based in the US

Leading Pharmaceutical Company located in NJ is hiring a Senior Clinical Pharmacologist w/3+ years industry experience. If you want to be a part of this groundbreaking work, please apply!

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, review, and refinement of study protocols, with emphasis on PK-related sections
• Prepare and review clinical pharmacology content for key clinical and regulatory documents, including clinical study reports, regulatory submission modules, and briefing materials (e.g., FDA briefing books)
• Collaborate with cross-functional teams to address PK-related questions and support timely delivery of clinical pharmacology 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

• 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 an understanding of 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
• 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

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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