Principal Scientist, Non-Clinical PKPD

Principal Scientist, Non-Clinical PKPD

ClinChoice

Slough, United Kingdom

The Principal Scientist will sit within the Non-Clinical PKPD group, who are searching for an enthusiastic, communicative, matrix-team operational individual with experience in non-clinical development PKPD, toxicokinetics analysis and reporting.

Main Job Tasks and Responsibilities:

• Participate in the development of non-clinical PKPD and GLP toxicokinetics studies;
• Lead the non-clinical PKPD strategy;
• Participate in protocol designs and writing by providing scientific support and input into regulatory study designs and protocols;
• Work collaboratively with the project team representatives (e.g. Non-Clinical Safety, Bioanalysis, Clinical Pharmacology) and with the CROs, to ensure high quality data is generated;
• Work under GLP compliance to deliver data packages that meet regulatory standards;
• Effectively communicate with the relevant team members to understand requirements and provide updates to ensure projects timelines are met;
• Analyse and communicate the results of interim and final PKPD/toxicokinetic data analysis to different stakeholders in a timely manner;
• Deliver PKPD study reports and integrated summaries of the studies and participate in regulatory submission documents;
• Facilitate the advancement of drug candidates by building a thorough knowledge of the drug pharmacology and PKPD;
• Represent the interests of the department internally and externally and contribute to enhancing the scientific reputation of Non-Clinical PKPD, Translational Science, and the company.

Education, Experience and Skills:

• PhD/MSc/BSc in a relevant discipline (quantitative pharmacology; pharmacokinetics/pharmacodynamics; DMPK, etc.) with more than 5 years hands on experience in PKPD data analysis within a pharma company or CRO environment;
• Good understanding of pharmacology and pharmacologic processes related to disease and drug mechanisms;
• Demonstrated experience in developing and executing effective non-clinical PKPD studies, and in delivering high-quality data packages for regulatory submissions;
• Experience working in a matrix environment, to help design and set non-clinical PKPD study protocols, and analyze, interpret, and report PKPD results including GLP toxicokinetics studies;
• Hands-on experience in delivering high quality pre-clinical PKPD data analysis. Proficiency in the use of Phoenix- WinNonlin for PKPD analysis is essential. Use of other modelling and simulation packages and tools, such as Berkeley Madonna and/or R would be advantageous;
• Able to handle several projects at any given time, to work successfully in project teams, and to communicate clearly to a variety of audiences;
• Good written and verbal communication skills, and ability to communicate study results and produce high standard reports that meet regulatory submission standards. Record of publications and other external scientific contributions relevant to PKPD will be a plus.