Opportunities in Clinical Pharmacometrics - AstraZeneca (Waltham, MA)

The role: Director (Sr. Pharmacometrician) / Associate Director (Pharmacometrician) Multiple Openings *Description* *This position could be a Career Level E or F depending upon the level of experience of the selected candidate.* AstraZeneca is one of the world's leading pharmaceutical companies, with strong positions in many therapeutic areas of the global pharmaceutical market. AstraZeneca's Research & Development is based in a number of centres of excellence with state of the art facilities in Sweden, United Kingdom and North America. AstraZeneca has a world-class record of innovative, important prescription medicines for the treatment of gastrointestinal, cardiovascular, and respiratory diseases, cancer, diseases of the central nervous system, as well as treatment of pain. In our efforts to bring better medicines to patients faster, AstraZeneca recognizes the critical role modeling and simulation play in nearly all aspects of drug discovery and development. We also recognize that our projects have benefited greatly from the consistent, integrated application of cutting-edge modeling and simulation approaches. To realize this ambition, we are making significant investments in people and in the underlying science and technology. Our vision is that all aspects of every project, from target validation to clinical trial design and interpretation, will utilize modeling and simulation in synergy, thereby making the results of our modeling and simulation efforts greater than simply the sum of the individual parts. The role This is a scientific role within our Quantitative Clinical Pharmacology group which is involved in candidate drug (CD) selection and in all clinical phases of the product development including registration and commercialization. We are looking for an individual to fill the role of a Director (Sr. Pharmacometrician) / Associate Director (Pharmacometrician) in the US. In the implementation of Model Based Drug Development (MBDD), the Sr. Pharmacometrician (Sr PM) will work closely together with other modeling skills (such as preclinical PKPD scientists, statistical modelers etc ) to develop MBDD plans for disease area related as well as compound related modeling. The Sr. PM will develop pharmaco-statistical models including disease models, exposure response models, biomarker - efficacy models etc. The Sr. PM will work as a partner in multi-disciplinary development teams by providing MBDD expertise. Effective collaborations with physicians, DMPK PK/PD scientists, statisticians, clinical pharmacologists and regulatory affairs experts are of key importance. The Sr. Pharmacometrician will, together with statisticians, have the overall accountability for the MBDD plan. We will also look to this individual to collaborate externally by publishing their work, building relationships with academic institutions and building their expertise by networking with individuals in the pharmacometric field. Individuals in the senior role will also be called upon to coach less senior staff in their modeling work. *Requirements* *Minimum experience:* For the Pharmacometrician role, candidates will have a doctorate degree (preferred) but a Master's degree and other relevant academic training is acceptable. Candidates should have demonstrated expertise in pharmacometrics and strong quantitative skills (e.g. experience in mechanistic modeling/systems pharmacology, quantitative translational scaling, literature meta-analyses, population modeling). The PM's experience may have been gained in a variety disciplines including pharmacology, pharmaceutical sciences, biostatistics, medicine, mathematics, physiology, or engineering. For the Sr. Pharmacometrician role, a doctorate degree with demonstrated expertise in pharmacometrics and strong quantitative skills (e.g. experience in mechanistic modeling/systems pharmacology, quantitative translational scaling, literature meta-analyses, population modeling) is required. The Sr. PM's experience (>10 years) may have been gained in a variety disciplines including pharmacology, pharmaceutical sciences, biostatistics, medicine, mathematics, physiology, or engineering. A minimum of 5 years pharmaceutical industry experience, specifically contributing to pharmacometrics aspects of clinical drug development, is essential. As is an in-depth knowledge of advanced PK and PK/PD, a proficiency with pharmacometric/statistical software tools such as NONMEM, SAS, S-Plus, R, Matlab, Berkeley Madonna, a knowledge of FDA/ICH requirements for drug registration, knowledge of Bayesian methods and Monte-Carlo simulation, PK and PD drug interactions, in vivo/in vitro models, biopharmaceutics and the ability to understand, and implement all aspects of pharmacometrics needs across a variety of disease areas. *Location* MA, Waltham External website: http://bit.ly/143B4Nn