Scientist I

Title: Scientist

Location: South San Francisco

Summary:

The Clinical Pharmacology Scientist is responsible for the Clinical Pharmacology (CP) strategy for his/her development project[s] in order to ensure that appropriate dose/route/schedule decisions are made for the patients.  The CP Scientist uses state of the art model-informed drug development strategies that are aligned with project needs. The CP Scientist works in close partnership with Pharmacometricians, Biostatisticians, Clinicians and cross-functional project teams. Responsibilities include; leading the design & review of CP study protocols and analysis plans where appropriate, contributing to the design and review of clinical protocols and analysis plans, analysis and interpretation of PK/PD data, preparation and review of clinical study reports, presentation of PK/PD data at cross-functional teams, department meetings, conferences and regulatory meetings as well as planning, implementation and organization of regulatory filings (eg. IND, End-of Phase 2 meeting, EU Scientific Advice meeting, BLA, NDA, sNDA). Performs other duties as assigned.

 

Skills:   

  • Familiarity with quantitative approaches in drug development, working knowledge of relevant modeling software (eg. NONMEM, ADAPTII, WinNonlin, Berkeley Madonna, R, S-Plus, SimCYP, GastroPlus) and the ability to plan, organize, and critically assess and/or perform PK/PD data analyses. 
  • Familiarity with clinical study design options, especially for phase 1 and 2 studies. 
  • Working knowledge of statistical approaches as they apply to clinical study design & analysis. 
  • Working knowledge of relevant disease areas.
  • The CP Scientist requires excellent communication skills, both written and oral, in order to deliver high quality protocols, regulatory documents, documents for team and management review.
  • Based on experience and ability, the CP Scientist may lead CP teams, project sub-teams and represent CP at cross-functional project teams. 
  • Based on experience and ability, the CP Scientist may manage other Scientists or Research Associates within CP department.

 

Education:         

MD, PhD, PharmD or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related quantitative discipline.

 

 

Why Kelly®?

Kelly® Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

Related jobs you might be interested in...
Clinical Scientist
South San Franci...
25 days ago
Full Time
Scientist I
South San Franci...
27 days ago
Full Time
Statistical Genetics/Data ...
South San Franci...
27 days ago
Full Time
One moment please...

Create an Account or sign in using one of your social networks by clicking an icon below. You can also Create an Account by uploading your resume

As of Sep 19, 2019 our security requirements for account passwords have been updated and you are required to click the Forgot Password link to create a new password.
Email
Password
Forgot Password        
Email
Verify Email
First Name
Last Name
Password
Verify Password

 

Choose your resume:
   
       
You currently don't have any resumes uploaded. Please upload one to continue.
Resume Title
Upload a Resume
Candidate Experience Site Guest User
Phone:
Email:
shadowblade3684@gmail.com
Time Zone:
EST (Eastern Standard)
Area(s) of expertise:
All
Communication Preference:
Thank you for your interest in this job.
Your resume has been successfully submitted.

What would you like to do next?


One moment please...