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PHARMACOKINETICIST II
Job Title: PHARMACOKINETICIST II
Job Code: 2691
FLSA: E
Job Level: 78
Revised Date: 07/01/2016
Job Family: JF 05
Occupational Summary
Under general direction, performs pharmacokinetic (PK) and pharmacodynamic (PD) analysis for multi-center phase I-IV clinical trials and/or clinical research projects. Collaborates closely with a cross-functional trial and project teams, physicians, and external government or industry representatives with regard to the pharmacokinetic aspects of each clinical trial or project.
Work Performed
With limited guidance, prepares PK analysis plans. Proficient in compartmental, non-compartmental and population PK/PD analysis. Independently performs PK/PD modeling and simulation. Learns new PK methods as needed, and applies new skills to future projects. Oversees the workflow and output quality, plans and reports of the Pharmacokineticist I projects. Provides feedback and analytical suggestions to Pharmacokineticist I.
Designs analysis dataset specifications through writing own code using PK software (NONMEM). Finds and corrects errors, and validates output and results. Performs complex programming such as data transposition and macros. Programs analysis datasets using statistical software; combines multiple disparate raw databases, and derives analysis variables accurately. Uses complicated PK software procedures and options, and programs with increasing efficiency. Leads or participates in the PK/PD team responsible for designing and validating analysis data sets, programs, and PK output products (tables, listings, figures). Generates proposals, calculates effort needed for projects, assists in preparation of budgets, assists in representing the pharamcometrics group at sponsor meetings, communicates directly with principal investigators (as needed).
Documents, analyses, creates summaries, and presents results in written and verbal form to requestors. Works on any phase of a clinical trial project, from the initial meeting with an investigator to final review of a manuscript prior to submission for publication or to FDA. This includes advising and writing PK sections of protocols and CSRs. Builds documentation and organizational skills to effectively return to a trial or manuscript project after long intervals during which no progress was made by other members of the project team. Contributes meaningfully to discussions of analyses and identifies next steps.
Collaborates effectively with statistical programmers who support their clinical trial projects. Perform queries and bring potential data problems to the team.
Represents the functional group in project team meetings, and contributes constructively to project discussions. Understands the contracted scope of work, and forecasts monthly hours expected to complete each trial deliverable. Helps create timelines for PK project management, with assistance from project leader. Drafts PK sections for clinical study reports, study synopses and protocols with guidance of faculty.
May help select and work with bioanalytic labs to ensure regulatory guidelines are being adhered to. Work with Pharmacokieticist I, bioanalytical teams and projects leaders to oversee method development and validation and innovate as necessary to meet program needs.
Assists with project oversight tasks related to PK deliverables, such as: budgeting, business development and project tracking. Adheres to standard operating procedures of the functional department as they apply to documentation and validation of PK projects. Ensures FDA, ICH, EMEA, NIH, or other regulatory agency guidelines are met as they apply to PK analysis for each project.
Handles and secures highly confidential and sensitive analyses and documentation. Supports the preparation of Data and Safety Monitoring Board reports and final PK and study reports, including those intended for regulatory submission, and collaborates with medical writers as needed. Collaborates closely with investigators, sponsors, and other trial leadership to ensure that trial and project results and conclusions are presented accurately and without bias.
Develops leadership and communication skills and shares them with others. Prepares manuscripts for peer-reviewed journal publication and presents PK concepts/analyses at cross-functional team meetings, conferences and regulatory agency meetings.
Required Qualifications at this Level
Education/Training
PhD or master's degree in pharmaceutical sciences/pharmacology; other applicable degrees (statistics, engineering, mathematics)
Experience
PhD plus a minimum of three years of experience in PK/PD analyses
Master's degree plus a minimum of 6 years of experience in PK/PD analysis
Skills
Knowledge of PK and pharmacology concepts and PK/PD analyses;
Knowledge of the use of clinical PK for designing early-phase human studies
Complete understanding of clinical trial and project data collection processes and data sets, and able to share knowledge with collaborators.
Complete understanding of the regulatory requirements for the essential bionalytical processes needed for PK analysis.
Possesses excellent interpersonal, presentation, and excellent communication skills to facilitate team interactions and convey project results to colleagues, clients and the larger scientific community. Demonstrate the ability to help with PK/PD and Pharmacometric activities from planning, implementation through completion; Ability to organize and work simultaneously on multiple projects
Knowledge of clinical trial simulations & pediatric drug development a plus
Knowledge on clinical database, PK/PD data compilation, and manipulation with scripting software of NONMEM and SAS, STATA, or R
Knowledge of PK/PD/statistical software including WinNonLin; SAS, STATA or R; and NONMEM to function independently under guidance
Good knowledge of Microsoft Word, Excel, and PowerPoint
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
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Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
