PK Scientist
PK Scientist We are seeking an experienced Clinical Pharmacology professional to support protocol development and pharmacokinetic/pharmacodynamic (PK/PD) analysis across Phase I–IV clinical trials as PK Scientist. This role involves protocol writing, non-compartmental analysis (NCA), and clinical pharmacology reporting while collaborating with cross-functional teams within a regulated clinical development environment. What You Will Be Doing:
- Author and coordinate development of clinical pharmacology trial protocols and ensure timely review, approval, and issuance.
- Perform preliminary, interim, and final PK, PD, and PK/PD analyses using non-compartmental methods.
- Develop the Clinical Pharmacology Analysis Plan (CPAP) and generate data handling logbooks prior to final NCA.
- Create tables, listings, and figures and contribute to drafting clinical pharmacology sections of Clinical Study Reports (CSRs).
- Conduct QC review of protocols, analyses, datasets, and all deliverables while ensuring compliance with SOPs, ICH-GCP, and regulatory requirements.
Your Profile:
- Bachelor’s degree or higher in a scientific discipline (or equivalent experience) with strong written and verbal communication skills.
- Hands-on experience with Phoenix WinNonlin and working knowledge of R for PK/PD analysis (Experience with R is an advantage).
- Experience performing non-compartmental pharmacokinetic analysis (NCA) and interpreting PK/PD data.
- Understanding of clinical trial data structures and experience collaborating with Data Management, Biostatistics, and CRO partners.
- 4+ years of relevant experience in clinical pharmacology, including exposure to clinical study protocols and regulatory requirements.
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 maximize 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 to read more about the benefits ICON offers. 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. Are you a current ICON Employee? Please click to apply Apply tot his job Apply To this Job