Senior Clinical Pharmacokinetic (CPK) Scientist At MedImmune, Senior CPK scientist functions as the global Clinical Pharmacology/DMPK (CPD) team representative for biotherapeutic projects all stages of research and development (target validation [milestone A] through life-cycle management [Phase IV]) and is responsible for all aspects of pharmacokinetic/pharmacodynamics (PKPD), clinical pharmacology, and metabolism -related support for biotherapeutic products, including input into the design of preclinical and clinical studies, analysis and reporting of PKPD data, contribution to sections of regulatory documents (IND/EOP2/BLA), and internal/external communication of data and strategy. Specific responsibilities include:
* Responsible for providing clinical pharmacology & PKPD input into clinical development plans, including: o the design, conduct and interpretation of relevant clinical pharmacology studies o PKPD studies, analysis of data using complex PKPD modelling and simulation (M&S) methodologies o contribution to appropriate sections of the study reports o development and delivery of CPD regulatory strategy (e.g IB/IND, end of phase 2, and BLA documents). * Function as the sole point of contact for all CPD activities on projects at all stages of discovery and development (from discovery through phase 3 and beyond) * Be integrally involved in assessing, performing, and managing M&S analyses of PK/PD data, integrating clinical trial simulation strategies and disseminating the clinically relevant risk/benefit implications to project teams. * Collaborate with biostatisticians, clinicians and clinical operation managers for the appropriate design of Phase I-IV studies; contribute to the investigators brochure, clinical study protocol and analysis and reporting of data, and communication of data in regulatory documents and meetings. * Collaborate with preclinical team to perform translational PK/PD M&S to support drug design goals, designs of preclinical PK/PD and safety assessment studies, and dosing justifications for first-in-human clinical studies * Collaborate with toxicologists on the design, monitoring, and reporting of nonclinical safety studies to support IND filings. The successful candidate will have the following skills: * Expertise with standard modelling and simulation software (NONMEM, S-Plus/R, etc) is required. * Strong understanding of the use of M&S and its role in discovery and development of therapeutics is required. * Strong communication skills including the ability to condense results of complex M&S analysis into actionable plans for project teams * A good track record of high-quality PKPD delivery, exemplified by a publication record and conference presentations. The following skills are desirable * A good understanding of the role of systems modelling and its utility in drug discovery and development * Expertise in other modelling software (e.g. MATLAB, Berkeley-Madonna, etc) * Specific knowledge of the PKPD aspects of biologics and their importance in guiding preclinical and clinical strategies. * Knowledge and previous experience of working in a GLP environment. * Ability to line-manage less experienced PhD level PK scientists and associates The successful candidate will have the following attributes: * Is a self-starter, who works independently to understand team strategy and is able to convert this into clin pharm strategy. * Has excellent communication skills to work with matrix teams to ensure proposed strategy is implemented * Is technically capable enough to develop solutions to complex problems requiring ingenuity and creativity. * Is comfortable with latitude in determining scientific objectives of assignment. * Is able to work well with people and display considerable problem solving skills through formal channels and informal networks. * Ability to multi-task with various projects at different stages - ability to prioritise and retain focus on delivery Education/Experience: MD, or PhD in Pharmacokinetics/Pharmaceutics/BioEngineering/Chemical Engineering/PharmD or PhD in other fields To apply for this position please follow the below link or apply via our career website (https://home.medimmune.com/careers) using reference 8561. http://www.candidatecare.com/srccsh/RTI.home?r=2000033425110&c=921&d=medimmune.candidatecare.com&_dissimuloSSO=Sb3XB_z5IIo:bz5iowEZqs4udBZfAr20qURcyhM [cid:[email protected]] Balaji Agoram, Ph.D Director, CPD, Cambridge Granta Park CB21 6GH. Ph +44 (0)1223898294 MedImmune Limited is a company incorporated in England and Wales with registered number: 02451177 and a registered office at Milstein Building, Granta Park, Cambridge, CB21 6GH. To the extent this electronic communication or any of its attachments contain information that is not in the public domain, such information is considered by MedImmune to be confidential and proprietary. This communication is expected to be read and/or used only by the individual(s) for whom it is intended. If you have received this electronic communication in error, please reply to the sender advising of the error in transmission and delete the original message and any accompanying documents from your system immediately, without copying, reviewing or otherwise using them for any purpose. Thank you for your cooperation. MedImmune Limited is a company incorporated in England and Wales with registered number: 02451177 and a registered office at Milstein Building, Granta Park, Cambridge, CB21 6GH. To the extent this electronic communication or any of its attachments contain information that is not in the public domain, such information is considered by MedImmune to be confidential and proprietary. This communication is expected to be read and/or used only by the individual(s) for whom it is intended. If you have received this electronic communication in error, please reply to the sender advising of the error in transmission and delete the original message and any accompanying documents from your system immediately, without copying, reviewing or otherwise using them for any purpose. Thank you for your cooperation.
