PK/PD Project Manager

As a PK/PD Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

The Pharmacometrics (PM) Reporting coordinator supports the global Pharmacometrics modelling team within Clinical Pharmacology & Pharmacometrics in delivering high quality support towards centralizing coordination of Pharmacometrics deliverables including reporting of various analyses (e.g., population PK, PK/PD, Model Based Meta Analysis and Quantitative Systems Pharmacology), quality control (QC) process, tracking the operational progress amongst stakeholders, and setting up a framework to facilitate the coordination of these activities.  This function liaises closely with pharmacometric leaders, clinical pharmacology leaders, and other team members.  Services are delivered by applying management and organizational skills, report writing and scientific QC.  Basic knowledge of Pharmacokinetics, Clinical Pharmacology and/or Pharmacometrics concepts is a plus.

Deliverables: 

BASE 

• Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc. 
• Clear communication with pharmacometric leaders, clinical pharmacology leaders and other team members.
• Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements.
• Central management of reporting of Pop PK/PKPD Analyses (.e.g Planning and ensuring reports get into the required databases).
• Support writing of PK/PKPD reports and manage review process, including comment resolution
• Maintain & continue development of Pharmacometric reporting templates, and analysis plans, data transfer plans, as required.
• Centralized support of QC process: ensures quality QC of Population PK/PD, MBMA and QSP reports in close collaboration with the Pharmacometrics Leader within projected timelines, in line with internal guidelines and analysis plan.
• Maintain oversight of outsourced deliverables related to review/reporting.
• Metrics and workload: facilitate our review of metrics and provide resource tracking for pharmacometrics deliverables.

You are:

Education and Experience Requirements/Qualifications:  

• Minimum degree: BA/BS
• Degree in a health, science, or computer science related field.
• 3 years industry experience.
• Proficient with templates and report processing tools.
• Experience in scientific report writing.
• Studious and data driven person with eye for detail.
• Proficient in speaking and writing in English. Effective communication skills, oral and written.

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.