Job details
Job type full-time number of hires for this role 2
Qualifications
Pk data analysis: 2 years (required)
Full job description
Position summary
At amador we provide global-standard translational sciences and clinical pharmacology services to biopharmaceutical companies in us, eu and chinaSupported by top vcs in technology and healthcare, amador aims to become a leading global partner for the successful development of novel and improved biotherapeutics.
Amador bioscience is seeking candidates to enhance and further our biopharmaceutical consulting services globally through high-quality work and publications/presentationsThey will assist clinical pharmacologist or pharmacometricians to design nonclinical and clinical studies, analyze and report pkpd data, and communicate the results with clients and regulatory agencies.
The primary function of a pk scientist is to support clinical pharmacology consulting project leaders through all stages of new drug development cycleHe/she will be responsible for all aspects of pk-related support, including data evaluation, interpretation, reporting, and generation of manuscripts/abstracts for publication.
Additional key attributes include:
Attention to details.
Highly self-motivated and willing to take on challenges.
Excellent critical-thinking, problem-solving skills, and organization skills.
Excellent communication skills.
Ability to build relationships and work closely with global internal and external teams.
Key responsibilities
Support clinical pharmacology project leaders by performing pk data evaluation, analysis, interpretation, reporting of nonclinical and clinical studies.
Perform noncompartmental data analysis; comply with gclp/glp regulations for glp toxicokinetic studies; prepare nonclinical pk/tk reports, clinical pk sub-reports, study protocols and data analysis plans.
Assist with the conduct of population pkpd modeling & simulations in collaboration with pharmacometrics project leaders; aid the preparation of technical reports and clinical pharmacology components of regulatory submission documents (e.gInd, eop2, bla/nda, ib).
Collaborate with clinical pharmacology project leaders and scientific writer to generate abstracts and manuscripts for external presentation and publication.
Work in team environment, involve in process improvement and sop development if needed.
Participate in meetings with clients or assist hosting client visits.
Other assigned responsibilities that are related to amador bioscience’s business.
Qualifications and education requirements
Education:
A bachelor or master’s degree in pharmaceutical sciences, biological sciences, mathematics, engineering, chemistry or other relevant scientific fields.
Experience:
Prior working experience in pharmaceutical industry is preferred but not required.
Special skills/abilities:
Strong analytical and technical writing skills are required for this position.
Good communication and organization skills are essential.
Prior experience with pk data analysis and reporting is highly desirable.
Familiar with glp/gclp practices is desirable.
Good written and verbal communication skills are required.
Job type: full-time
Benefits:
401(k)
401(k) matching
Dental insurance
Flexible schedule
Health insurance
Life insurance
Paid time off
Referral program
Retirement plan
Vision insurance
Schedule:
Monday to friday
Supplemental pay:
Bonus pay
Application question(s):
Please elaborate on your experience supporting all aspects of pk-related; including data evaluation, interpretation, reporting, and generation of manuscripts/abstracts for publication?
Experience:
Pk data analysis: 2 years (required)
Work location:
Fully remote
Work remotely:
Temporarily due to covid-19
Work location: remote
