PK Scientist

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

What you will be doing:
The services requested are for protocol writing of Phase 1 clinical pharmacology studies, pharmacokinetic and/or pharmacodynamic analysis using non-compartmental methods, and reporting for clinical trials Phase I – IV utilizing Phoenix WinNonlin and R.

• Services rendered will adhere to applicable  SOPs, Work Instructions, policies, local regulatory requirements, ICH-GCP guidelines, etc.
• For clinical pharmacology trial protocols, author the protocol and coordinate the overall development of the protocol with study team members, and ensure timely approval and issuance of the document.
• Provide QC review of protocols as needed.

• Review dataset requirements (i.e., trial specific data transfer agreement) for clinical studies with non-compartmental analysis (NCA).
• Write the Clinical Pharmacology Analysis Plan (CPAP) based on the protocol.

• Generate a logbook with data handling rules prior to the final NCA.

• Perform preliminary, interim, and final PK, PD, and/or PK/PD analysis for trials in all phases of drug development.
• Creation of tables, listing and figures based on the CPAP.
• Draft the clinical pharmacology sections of the Clinical Study Report.
• QC of analysis, all delivered outputs, and of documents reporting the analysis.

You are:

• Bachelor’s degree or higher and / or equivalent preferably with science background
• Demonstrated written and verbal communication.
• Working knowledge of Microsoft suite of software product
• Knowledge of Phoenix WinNonlin is a must.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.