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Occupational Summary

Performs intermediate-leve lpharmacokinetic (PK) and pharmacodynamic (PD) analysis for multi-center phaseI-IV clinical trials and/or clinical research projects. Demonstrates technical expertise for Pharmacokineticist I roles . Must have demonstrated ability to help with PK/PD and Pharmacometric activities from planning, implementation through completion. 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 and non-compartmental PK 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.

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 data sets using statistical software; combines multiple disparate raw databases, and derives analysis variables a ccurately. 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, an d PK output products (tables, listings, figures).

Documents, analyses,creates summaries, and presents results in written and verbal form to requestors. Able to work 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. Demonstrates understanding of clinical trial and project data collection processes and datasets, and shares knowledge with collaborators.

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 or Pharmacokieticist III.

Understands the regulatory requirements for the essential bionalytical processes needed for PK analysis.May help select and work with bioanalytic labs to ensure regulatory guidelinesare being adhered to. Work with PharmacokieticistI, 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. Understands guidelines from the FDA, ICH, EMEA, NIH, or other regulatory agenc y as they apply to PK analysis for each project.

Handles and secures highly confidential and sensitive analyses and documentation. Supports the preparationof 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.

Possesses excellent interpersonal, presentation, and communication skills to facilitate team interactions and convey project results to colleagues, clients and thel arger scientific community. 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.

Performs other relatedduties incidental to the work described herein.

Skills

Knowledge on clinical database , PK/PD data compilation, andmanipulation with scripting software of NON MEM and SAS, STATA, or R

Knowledge of PK/PD/statistic al software includingWinNonLin; SAS, STATA or R; and NONMEM to function independently under guidance

Knowledge of clinical tr ial simulations a plus

Knowledge of pediatric drugde velopment a plus

Good knowledge of Microsoft Word, Excel, and PowerPoint

Good written and oral presentatio nskills

Ability to organize and work simultaneously on multiple projects

PhD or master's degree in pharmaceutical sciences/pharmacology; other applicable degrees (statistics, engineering, mathematics)

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

** NOTE: This position may have an opportunity to work remotely. All Duke University and Duke Health remote workers must reside in one of the following states or districts: Arizona; California; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia or Washington, DC.

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Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob 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.