Senior Pharmacokinetic Scientist 1

Company: BioPharma Services Inc.

Position Title: Senior Pharmacokinetic Scientist 1

Hourly Rate: $40-$60

Job Class: Part-time, 28 hours per week

Work Location: Remote

Position Summary: 

The Senior Pharmacokinetic Scientist 1 is responsible for providing scientific expertise for the design, analysis, reporting, and presentation of pharmacokinetic data for inhouse studies. They also provide scientific support to the other company divisions and acts as a scientific consultant with the clients. The Senior PK Scientist 1 will provide trainings and supports to other team members as appropriate.

Duties and Responsibilities:

• Design and/or Performs literature and data evaluation to provide scientific background for clinical studies design
• Prepares the PK portion of synopses for clinical studies
• Answers inquiries in process of preparation and reviews study protocols
• Performs/reviews pharmacokinetic analysis of concentration-time data with the up-to dated software such as WinNonlin 
• Perform modeling analyses with PK software for PK level prediction or IVIVC 
• Prepares the pharmacokinetic section of clinical study reports
• Interacts and provides input and feedback to Biostatistics Department for data analysis
• Reviews statistical output to evaluate study results
• Reviews study reports
• Provides scientific support to other departments and teams in the areas of pharmacology, pharmaceutics and pharmacokinetics
• Attend and provide scientific support during meeting with client or agency 
• Lead the Pharmacometrics Department and the company SOPs update and involved in creating new SOP; provides input into departmental practices and in charge of maintaining updated the study- and report-related templates
• Maintains the Pharmacometrics Department databases; provides the department and the company with updated scientific literature and maintains regulatory guidelines updated
• Provide trainings and supports to PK associate and PK scientist as needed and per assigned by manager.

Qualifications:

• M.Sc. in Pharmacy/Pharmacology or related field plus minimum 3-year experience with clinical trials design/data analysis 
• Expertise in the fields of pharmacology and pharmacokinetics plus PK PD modeling experiences 
• Proven abilities in literature evaluation, scientific and medical writing and scientific support 
• Demonstrate the good mentoring and leadership ability
• Demonstrated critical analytical thinking with strong attention to detail
• Good organizational skills and ability for multitasking and prioritization; effective time management