PK Scientist
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Job Description
Senior PK Scientist providing clinical pharmacology expertise in protocol development and analysis for Phase I–IV clinical trials. Collaborating with cross-functional teams in regulated environments.
Responsibilities:
- 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
Requirements:
- Bachelor’s degree or higher in a scientific discipline (or equivalent experience) with strong written and verbal communication skills
- 4+ years of relevant experience in clinical pharmacology, including exposure to clinical study protocols and regulatory requirements
- Excellent hands-on knowledge of PK & PD software packages
- Hands-on experience with Phoenix WinNonlin and working knowledge of R for PK/PD analysis (Experience with R is an advantage)
- Excellent data-handling skills and working knowledge of database structures
- Working knowledge noncompartmental PK analysis & PK/PD analyses
Benefits:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
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