Principal Scientist - PK/PD Modeling & Simulation (Oncology) Job Listing at AstraZeneca in Waltham, MA

Biotechnology, Science/Research

  At AstraZeneca, our aim is to tackle illness and disease as effectively as possible. Through our RD pipeline of life-changing medicines, we're able to offer hope to millions around the world. And innovation is essential to our job. Our strategy includes a substantial application of Predictive Sciences, which help us to deliver drugs that tackle illness and disease even more effectively. The model-based approach is applied to the whole drug development process, and this includes developing a quantitative understanding of the biological hypothesis of drug action on the disease target. An understanding of pre-clinical quantitative pharmacology underpins our human predictions of dose, dose schedule, and therapeutic index and these predictions are critical to drug projects.   The Oncology Innovative Medicines unit (iMED) has an exciting opportunity for an experienced Modeling and Simulation (MS) scientist to join a vibrant global team. The individual will be embedded into the Oncology research group, working closely with scientists in Biology, Translation, Safety and other modelers. The successful candidate will have excellent problem solving, organizational, and documentation skills, in addition to strong oral and written communication skills. This role requires the ability to thrive in a team-based, multidisciplinary, fast-paced research environment.   Description:   The Modeling and Simulation (MS) Scientist provides the projects with an understanding and integration of the correlation between in-vitro and in-vivo ADME properties and the relationship between pharmacokinetics/toxicokinetics, pharmacodynamic responses, and efficacy. The role will have project oversight of quantitative pharmacology and PKPD modeling. The expert will have deep knowledge of MS techniques and their application in drug discovery and development and will need to partner effectively with a wide variety of peers in Oncology and global functions in order to apply robust and innovative science to projects. The individual will be expected to contribute to and lead science and strategy groups through a global MS discipline.   Major responsibilities:   * Deliver the preclinical and translational PKPD work in targets/projects from Target Validation to post-approval life-cycle management.
* Work collaboratively across multiple disciplines, including Bioscience, Translational Science, Safety, and Clinical Pharmacology to drive the quantitative pharmacology strategy into projects; use and refine best practice to ensure continuum of MS from pre-clinical to clinical.
* Design pre-clinical forward and backward translational PKPD and TKPD studies and report results to project teams.
* Deliver drug-drug interaction predictions and risk assessments to project teams and contribute to regulatory reports.
* Calculate safety margins and make recommendations and predictions/simulations on human dose and exposure together with the (senior) clinical pharmacologist/pharmacometricians as appropriate.
* Evaluate and interpret PKPD and TKPD data to prepare for internal governance bodies.
* Prepare the PKPD part of regulatory documents (e.g. IND, IMPD, IB, NDA).
* Maintain high level of visibility in MS field through active publication in conference proceedings and peer-reviewed journals.
* Contribute significantly to the development and implementation of MS external collaborations responding to emerging science and meet the short- and long-term needs of the portfolio.
* Effective mentoring for more junior MS, PK, and TK scientists and help them resolve issues through development of their technical/scientific skills and through appropriate leadership capabilities.
* Create a vibrant and innovative working environment where improvements and new ideas are adopted and freely shared among the teams.   Other Responsibilities
* Ensure compliance with corporate code of conduct guidance and ensuring adherence to best SHE practice.   Key Deliverables
* Deliver PKPD and TKPD elements to project teams and DMPK Project Leader within the agreed timelines and to the right quality.     Minimum Requirements:   * PhD or equivalent degree in a discipline with a significant component of Modeling Simulation, such as systems biology, quantitative pharmacology, pharmacometrics, chemical engineering, physics, or applied mathematics, with at least 5 years of relevant industry experience in Modeling Simulation, ideally in preclinical/translational setting, or an MS degree with at least 10 years of relevant industry experience.
* Experience in project-facing role at pharmaceutical RD.
* Comprehensive understanding of DMPK and pharmacology/safety aspects of drug discovery and development.
* Track record of supporting PK, PKPD and TKPD aspects of projects, with a delivery focus and ability to meet timelines to pre-specified quality and cost.
* Specialist in tools such as WinNonLin/Phoenix NLME, NonMem, Berkeley Madonna, MATLAB, and SimCYP
* Experience in project-facing role at pharmaceutical RD.
* Comprehensive understanding of DMPK and pharmacology/safety aspects of drug discovery and development.
* Track record of supporting PK, PKPD and TKPD aspects of projects, with a delivery focus and ability to meet timelines to pre-specified quality and cost.
* Specialist in tools such as WinNonLin/Phoenix NLME, NonMem, Berkeley Madonna, MATLAB, and SimCYP.