Trial Clinical Pharmacologist

Company: BioPharma Services Inc.

Position Title: Trial Clinical Pharmacologist

Hourly Rate: $40-$60

Job Class: Part-time, 28 hours per week

Work Location: Remote

Position Summary: 

The Trial Clinical Pharmacologist (TCP) supports the clinical drug development of new drugs and further development of approved drugs by providing clinical pharmacology input and by developing the clinical PK/PD aspects of clinical trial protocols and clinical trial reports as well as by supporting trial conduct. This happens in cooperation and alignment with other functional groups and in close cooperation with other trial team members. 

This position is a part-time contracted position and requires the TCP to work and report directly for a large international pharmaceutical company. Projects will include Phase I to III.

Duties and Responsibilities:

• Support clinical study execution by performing necessary tasks such as contribution to documents (e.g., Trial Statistical Analysis Plan, Case Report Form and Analysis Dataset Specification document) and participation in trial team meetings (Trial Oversight Meeting, Blinded Report Planning Meeting, Medical Quality Review Meeting and Results Alignment Meetings, etc.). 
• Support the manager/supervisor in the generation of submission summary documents (e.g., Summary of Biopharmaceutic Studies and Associated Analytical Methods or Summary of Clinical Pharmacology) or pooled analysis reports as per the project needs. 
• Steer exploratory and final non-compartmental analysis of PK/PD data and overview the generation of graphs and tables from the results and present/communicate the results to the trial team and/or project teams as appropriate. 
• Develop processes and scientific knowledge as regards clinical pharmacology aspects of clinical trials. Contribute to national and global harmonization within the Clinical Pharmacology (CP) and Data Science groups (e.g., descriptive analysis team).
• Present study protocols and results in meetings of Clinical Pharmacology group, Translational Medicine, and Clinical Pharmacology (TMCP) department as well as trial/project specific meetings such as trial team meetings, project teams meetings, medical sub team and Drug & Device team meetings, etc. 
• Present at panel and/or committee meetings (e.g., Clinical Expert Committe, Development Committee), external meetings (e.g., investigator meeting). Represent other TMCP functions like descriptive analysis team or Data concepts and services team for CP aspects in the trial team.
• Interact closely with other groups in the department of TMCP (e.g., Biomarker Integrators, Translational or TMCP Leads, Biomarker Platform, Data Science Leads). Depending on the study, TCPs also interacts with other groups and departments (e.g., Biostatistics and Data Sciences, Clinical Operations, Pharmaceutical Development, DMPK etc.) and with CROs (outsourcing).
• Contribute to scientific posters and publications.

Qualifications:

• At least M.Sc. (or equivalent) in Medicine, Pharmaceutics, Clinical Pharmacology or equivalent area.
• Expertise in the fields of Clinical PK/PD with a minimum of 2-6 years relevant in the pharmaceutical industry, regulatory agencies, or academia. 
• Knowledgeable in clinical PK/PD, biopharmaceutics, and relevant regulatory guidelines.
• Proficiency in graphic software packages.
• Proven abilities in understanding and interpretation of statistical output.
• Good presentation and team-work skills. 
• Strongly independent and diligent.