of Job Responsibilities:
• Reads and understands the Clinical Study Protocols, Cytel Work Request Documents, and Project Requirements.
• Prepares and reviews Pharmacokinetic Analysis Plan (PKAP) using Clinical Study Protocols and Study Specifications.
• Performs Integral data management, data cleaning process, and integration with Phoenix WinNonlin® software.
• PK/PD analysis using Phoenix WinNonlin® 8.1 or higher software, in accordance with study specifications.
• Plays an active role in planning, execution and delivery of pharmacokinetic assignments ensuring on-time quality deliveries.
• Creates Tables, Listings, and Figures (TLFs), and summary reports for regulatory submission.
• Interprets PK results and prepares pharmacokinetic content for Clinical Study Reports (CSRs).
• Perform quality control and quality assurance of PK deliverables as per the client assignment specifications.
• Provide strategic leadership to a team in conducting clinical pharmacokinetic studies, ensuring timely execution and adherence to guidelines.
• Should be proactive to pursue advanced technological aspects and mentor the team members in various technical and strategic aspects to meet the organization objectives.
• Acts as the primary client interface for technical support and project coordination, attending meetings to capture evolving requirements, track commitments, and ensure timely delivery.
• Should closely work with the higher management and business team for the effective project management
• Co-ordinates cross-functional activities involving statisticians, SAS® programmers and medical writers involved in pharmacokinetic projects.
• Co-ordinates with the client and US-team for clarity of specifications, data issues, reviews, schedules, etc.
• Reads and thoroughly understands applicable compliance standards such as GCP, 21CFR11, ISO 17799 and client’s SOPs.
Minimum Education:
Master of Pharmacy (M. Pharmacy) / in Pharmacology/Pharmaceutics/Pharmaceutical technology
Minimum Work Requirements:
8-10 years of hands-on experience in PK/PD analysis, interpretation and reporting of clinical trials data using Phoenix WinNonlin® software.
Should have profound knowledge in biopharmaceutics, pharmacology, clinical research, pharmacokinetics and pharmacodynamic (PK/PD) concepts.
Should be proficient in the concepts of Clinical Trials, Good Clinical Practices (GCP), SOPs and regulatory specifications.
Should have good academic credits and excellent communication skills (oral and written).
Skills:
Expertise in Phoenix WinNonlin® software in creating workflows independently.
Demonstrated strong understanding of Drug Discovery and Development, PK/PD principles, physiology/pharmacology and biopharmaceutics through scientific presentations, posters, and publications.
Proficiency in Medical and Scientific writing.
Knowledge in using GraphPad Prism, R Programming and SAS® software.
Thorough knowledge regarding International Conference on Harmonization-Good Clinical Practice. Basic Knowledge regarding Clinical Trials Methodologies
Cytel is the world’s leading data-science CRO, driving advancements in human health through robust analytics and innovative clinical trial software. For nearly four decades, we have set the standard in adaptive trial design, leveraging extensive data insights to inform strategy throughout every phase of drug development and commercialization. Our mission is clear: accelerate drug development, enhance success rates, and deliver better patient outcomes. With a comprehensive suite of services from innovative trial design to end-to-end biometrics and real-world evidence, our specialized, multidisciplinary team ensures optimal strategies for preclinical research, trial execution, market access, and reimbursement.
Headquartered in Cambridge, Massachusetts, Cytel has a global presence with over 2,000 employees across North America, Europe, and Asia. Learn more about how Cytel is harnessing the power of data to advance human health at www.cytel.com.
