Principal Scientist PKPD Non Clinical

The Non-Clinical PKPD group sits within the recently formed Quantitative Clinical Pharmacology function of the Early Clinical Development and Translational Sciences Department. Our goal is to use integrated quantitative approaches; as an essential strategic driver from target to market; to bring differentiated solutions to patients. We are driving the quantitative integrated strategy of pharmacokinetics and pharmacology (e.g. PKPD, Systems modelling, clinical pharmacology/pharmacometrics) together with DMPK activities throughout the entirety of the lifetime of projects, from target identification through to life cycle management. We operate and collaborate closely with colleagues across Early Clinical Development & Translational Sciences, which, as a department, is responsible for providing strategy and support in bioanalysis, immunogenicity, safety, pathology, and regulatory activities.

Our group has a one-year contract vacancy, for an enthusiastic, communicative, matrix-team operational individual with experience in non-clinical development PKPD/toxicokinetics analysis and reporting to join us.

Role 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 teams 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.

• Effective communicate with the relevant team members to understand requirements and provide updates to ensure projects timelines are met.

• Analyse and communicate to different stakeholders the results of interim and final PKPD/toxicokinetic data analysis 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 and Translational Science

Requirements

• PhD/MSc/BSc 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.