Trial Clinical Pharmacologist

Company Overview

BioPharma Services Inc. is recruiting for the role of Trial Clinical Pharmacologist (TCP), a part-time position working remotely at 28 hours per week. The TCP contributes to the clinical drug development process for new and existing drugs by integrating clinical pharmacology expertise into trial protocols and reports, collaborating closely with multifunctional trial teams.

Key Responsibilities

• Assist in clinical study execution via contributions to key documentation such as Trial Statistical Analysis Plans, Case Report Forms, and Analysis Dataset Specifications.
• Participate actively in various trial-related meetings including Trial Oversight and Medical Quality Review sessions.
• Support supervision in preparing regulatory submission summaries and pooled analyses tailored to project demands.
• Lead exploratory and final analyses of pharmacokinetic/pharmacodynamic (PK/PD) data; oversee graphical and tabular presentation of results for internal communication.
• Enhance processes and scientific understanding related to clinical pharmacology in trials, helping harmonize practices at national and global levels within relevant groups.
• Present protocols and findings across multiple forums such as Clinical Pharmacology Groups, Translational Medicine meetings, and project-specific committees.
• Represent clinical pharmacology interests in multidisciplinary trial teams and external meetings including investigator and expert committee sessions.
• Maintain collaboration with various departments including Biomarker Integrators, Biostatistics, Data Sciences, Clinical Operations, Pharmaceutical Development, and Contract Research Organizations.
• Contribute to scientific posters and publications to disseminate findings.

Qualifications and Experience

• A Master's degree or equivalent in Medicine, Pharmaceutics, Clinical Pharmacology, or a related field.
• Between 2 to 6 years of relevant experience in pharmaceutical industry, regulatory agencies, or academia focusing on clinical PK/PD and biopharmaceutics.
• Deep understanding of clinical pharmacokinetics and pharmacodynamics, regulatory guidelines, and clinical biopharmaceutics.
• Skilled in graphic software tools for data visualization.
• Ability to interpret statistical outputs effectively.
• Strong presentation skills, with a collaborative and independent work approach.

Additional Information

• Employment is part-time (28 hours per week).
• Location is fully remote.
• Hourly compensation ranges from $40 to $60.