Sr. Scientist, Clinical Pharmacokinetics-REMOTE

CarterMacKay; United States; Remote; USD 100,000 - 130,000; Full time

Job summary

A leading organization is seeking a Sr. Scientist in Clinical Pharmacokinetics to drive innovative research and support clinical development. This remote position involves critical analysis and collaboration with cross-functional teams to enhance drug efficacy and safety measures. The ideal candidate will have a strong background in Clinical Pharmacology and experience in regulatory documentation. Join us to make a significant impact in the field of pharmacokinetics.

Qualifications

• Lead PK scientist with expertise in Clinical Pharmacology.
• Experience in authoring regulatory documents and scientific publications.

Responsibilities

• Conceive and execute scientific research in Clinical Pharmacology.
• Support clinical development for Phase 1-4 studies.
• Conduct data analyses including modeling and simulation.

Skills

Clinical Pharmacology

Pharmacokinetics

Data Analysis

Regulatory Science

Education

PhD in Pharmacology or related field

Job description

Sr. Scientist, Clinical Pharmacokinetics - REMOTE

Description:

The organization is responsible for defining the relationship between drug exposure (e.g., concentrations in blood) and efficacy measures (primary and/or secondary clinical outcomes or biomarkers) to select the optimal dose and dosing intervals. CPPM is also responsible for defining the relationship between drug exposure and safety measures (clinical outcomes or biomarkers, e.g., QTc) to identify populations that may be at risk of increased toxicity or decreased tolerability.

CPPM performs the selection, design, and interpretation of all Phase I studies, including first-in-human, bioavailability/bioequivalence/food effect, drug interaction, pilot/definitive cardiovascular (QTc), special population, pharmacogenetic, and immunogenicity studies.

The organization provides critical support for conducting technical due diligence of new business opportunities (both in-licensing and out-licensing) by assessing the probability of success for achieving the Target Product Profile (TPP). CPPM contributes to defending intellectual properties, extending patent protection, supporting life-cycle management of marketed products, responding to post-marketing safety questions, legal, manufacturing, and regulatory inquiries worldwide, and publishing scientific information in patents and manuscripts. The Clinical Pharmacology and Pharmacometrics Organization (CPPM) leads strategy, data generation, analysis, interpretation, reporting, and communication with global regulatory agencies in areas of Clinical Pharmacology, Pharmacokinetics, Exposure-Response, and Biopharmaceutics.

Responsibilities:

• Conceive and execute novel scientific research or development in Clinical Pharmacology that aligns with project goals and CPPM objectives. Generate new PK/PD proposals and lead those efforts.
• Investigate, identify, develop, and optimize new methods and techniques in the PK/PD field.
• Act as a lead PK scientist in your area of expertise, critically evaluate relevant advances in Clinical Pharmacology, PK/PD, and regulatory science, and integrate this knowledge into research or development programs.
• Support clinical development by contributing to Phase 1-4 studies, including study design and clinical pharmacology strategy.
• Author regulatory documents such as protocols, study reports, population PK reports, exposure-response analysis reports, sections of investigator brochures, common technical documents, white papers, etc.
• Conduct data analyses including non-compartmental analyses, modeling, simulation, and literature data reviews.
• Participate and present at departmental and cross-functional teams such as study teams, clinical pharmacology, biopharmaceutics, clinical strategy, CPPM leadership, and journal clubs.
• Collaborate with scientific support from other CPPM groups to provide a unified clinical pharmacology position to clinical, CMC, and regulatory teams.
• Author scientific publications and present at scientific conferences.

Contacts:

***For a comprehensive list of over 25 openings, please contact Brenda Roseberry directly.***

Position: Sr. Scientist, Clinical Pharmacokinetics - REMOTE

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