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About the Role
The Senior Pharmacokinetic Scientist 1 provides scientific expertise for the design, analysis, reporting, and presentation of pharmacokinetic data for inhouse studies. They also offer scientific support to other company divisions and act as a scientific consultant to clients. This role includes training and supporting other team members.
Responsibilities
- Designs and performs literature and data evaluation to provide scientific background for clinical studies design.
- Prepares the PK portion of synopses for clinical studies.
- Answers inquiries during study preparation and reviews study protocols.
- Performs/reviews pharmacokinetic analysis of concentration-time data using software such as WinNonlin.
- Performs modeling analyses with PK software for PK level prediction or IVIVC.
- Prepares the pharmacokinetic section of clinical study reports.
- Interacts with and provides input and feedback to the Biostatistics Department for data analysis.
- Reviews statistical output to evaluate study results.
- Reviews study reports.
- Provides scientific support to other departments and teams in pharmacology, pharmaceutics, and pharmacokinetics.
- Attends and provides scientific support during meetings with clients or agencies.
- Leads the Pharmacometrics Department and company SOP updates, and is involved in creating new SOPs.
- Provides input into departmental practices and is responsible for maintaining updated study- and report-related templates.
- Maintains the Pharmacometrics Department databases.
- Provides the department and company with updated scientific literature and maintains regulatory guidelines.
- Provides training and support to PK associates and PK scientists as needed and assigned by management.
Requirements
- M.Sc. in Pharmacy/Pharmacology or related field.
- Minimum 3 years of experience with clinical trials design/data analysis.
- Expertise in pharmacology and pharmacokinetics.
- PK PD modeling experience.
- Proven abilities in literature evaluation, scientific and medical writing, and scientific support.
- Demonstrated mentoring and leadership ability.
- Demonstrated critical analytical thinking with strong attention to detail.
- Good organizational skills.
- Ability for multitasking and prioritization.
- Effective time management.
Skills
- Pharmacokinetics
- Pharmacology
- PK PD modeling
- Clinical trials design
- Data analysis
- Literature evaluation
- Scientific writing
- Medical writing
- WinNonlin
- Mentoring
- Leadership
- Analytical thinking
- Attention to detail
- Organizational skills
- Multitasking
- Prioritization
- Time management
Location
- Remote
Work Type
- Part-time
- 28 hours per week
Experience Level
- Senior
- Minimum 3 years
Education Level
- M.Sc. in Pharmacy/Pharmacology or related field
Salary/Compensations
- $40-$60 per hour
About the Company
- BioPharma Services Inc.