Principal Clinical Pharmacokinetist - IC

As the global biologics research and development arm of AstraZeneca, MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic including respiratory, inflammation, and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines.

At MedImmune, Principal CPK scientist functions as the global Clinical Pharmacology/DMPK (CPD) team representative for biotherapeutic projects at various stages of research and development (target validation through life-cycle management) and is responsible for all aspects of pharmacokinetic/pharmacodynamics (PKPD) -related support for biotherapeutic products, including design of studies, analysis and reporting of data, and communication of data in regulatory documents and meetings.

* Responsible for providing clinical pharmacology expertise into clinical development plans, including the design, conduct and interpretation of relevant clinical pharmacology studies, including PKPD studies, analysis of data using complex PKPD modelling and simulation methodologies, development and delivery of regulatory strategy (e.g IB/IND, end of phase 2, and BLA) etc, and data analysis and reporting of clinical studies. * Function as the sole point of contact for all CPD activities on projects at all stages of discovery and development and be able to influence team strategy using modelling expertise. * Be pivotally involved in assessing and managing analyses of PK/PD data, integrating clinical trial simulation strategies and disseminating the clinically relevant risk/benefit implications to the Company's clinical development 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 report analysis and reporting of data, and communication of data in regulatory documents and meetings. * Drive clin pharm regulatory strategy for projects at all stages -- IND to BLA -- and defend strategy at regulatory meetings. * Help design and conduct translational PK/PD modelling and simulation to support drug design goals, designs of 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; prepare TK subreports; comply with good laboratory practice (GLP) regulations for GLP studies. Perform PK analyses for GLP studies per SOPs, record data and analysis results in GLP-compliant manner, ensure timely and clear communication with GLP SD/PI on GLP studies, contribute to GLP study reports. * Mentor other junior PK scientists staff on clin pharm science and strategy.

* Expertise with standard modelling and simulation software (NONMEM, S-Plus/R, etc) is required. * Knowledge of the use of modelling simulation and its role in discovery and development of therapeutics is required. * Strong publication and conference presentation track-record required. * Expertise in other modelling software (e.g. MATLAB, Berkeley-Madonna, etc) is highly desirable * Knowledge of bioanalytical expertise, especially of biologics is desirable. * Knowledge of biologics discovery and development - especially knowledge of bioanalytical strategy and GLP is desirable. * A doctorate degree in Pharmaceutics/Pharmacy/Engineering/Statistics with demonstrated expertise in PKPD and clinical pharmacology and strong quantitative skills. * 8+ years of experience after PhD required. * Proven track record of extensive experience in population modeling and simulations using NONMEM. Familiarity with statistical software package Splus, R or SAS. * Good communication and scientific writing skills, and ability to independently work in a matrix environment