Do you want to watch clinical development change, or do you want to be the one to shape it?
Because we’re hoping you’re here for the latter.
Who are we?
We Are PRA.
We are 12,000+ employees strong, operating in more than 80 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting lifesaving drugs into the hands those who need them most.
What will you be doing?
Conducts PK/PD analyses, interprets and reports results, and contributes to all phases of a clinical study involving PK/PD characterization
On the project level, assists in study start-up activities and evaluates data related to the PK/PD characterization of a drug
- Participates as a key team member on PK/PD projects
- Provides specific input into PK/PD study CRF design to ensure complete collection of data required for proper PK/PD analysis
- Assists or writes PK/PD sections of Statistical Analysis Plans
- Performs PK/PD data analysis and assists in interpreting the statistical results
- Assists in writing PK/PD sections of Clinical Study Reports
- Designs PK/PD studies; assists in writing clinical study protocols
- Works with investigators and their staff and participates in investigator meetings to ensure proper PK/PD collection techniques, sample handling, storage, and shipping
On the program level, provides scientific expertise and oversight to drug development and/or clinical trial project teams through all program stages
- Provides expertise regarding bioanalytical data interpretation for the client and internally
- Provide expertise in PK modeling, simulations and Population modeling
- Writes or assists with writing of PK/PD sections of regulatory submission documents or manuscripts
- Performs scientific literature searches and other research to support strategic overview planning and writing of proposals in support of individual clinical trials or for full development programs
- Collaborates with clients on the design of drug development programs
- Works directly with the project team to provide expertise on the importance of critical PK/PD data in the analytical process and their intended use in a report or submission
- Assists with the writing of clinical development plans and business plans
- Participates in the RFP process
- Provides feedback regarding PK/PD bids; may participate in RFP bid defense