Manager, Quantitative Clinical Pharmacology Lead

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.  I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Our Data and Quantitative Sciences group (DQS) is made up of more than 500 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance, digital strategy, library sciences, and data architecture/governance) bring their expertise to our global program teams and reimagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation. As part of DQS, the Quantitative Clinical Pharmacology (QCP) Team at Takeda consists of therapeutically aligned teams who drive the clinical pharmacology strategy from pre-FIH through life-cycle management within the global project team. The QCP role works in partnership with the pharmacometrics lead to drive a MIDD path within each project. How you will contribute: Position Objectives: Provides clinical pharmacology support at study or project level. Possesses primary responsibility for   dosage selection and generation of causality evidence Provides additional portfolio support through program reviews, collaborative decision-making, infrastructure and best practice initiatives. Explores and excels in synergistic relationships with experts in digital health, global outcomes/ epidemiology, biostatistics, and other key data science disciplines. Serves as an ambassador of Quantitative Clinical Pharmacology (QCP) and Data and Quantitative Sciences (DQS) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications. Accountabilities: Provides study level support to assigned projects with some level of supervision. Creates or assists in the preparation of protocol synopses, oversees program execution including protocol conduct, data analysis and reporting. Contributes to clinical pharmacology content in regulatory submission documents such as briefing book, IB, IND, CTA, CTD Module 2 documents, CCDS, and product labeling. Oversees and/or independently performs PK, PD, or pharmacometrics analyses including the interpretation of PK/PD data in close partnership with DSI and external partners.