RESPONSIBILITIES AND ACCOUNTABILITIES:
1 Design and implement in vitro and ex vivo studies to investigate the mechanism of action of lead therapeutic candidates, understand disease patho-mechanisms and drive target validation activities.
2 Design appropriate PD response/biomarker strategies and assays to support non-GLP/GLP toxicology studies and first in human clinical studies/early clinical studies, including writing Biomarker Strategy Documents and leading Biomarker Expert Teams.
3 Collaborate with Immunology focused In vivo pharmacology researchers to provide pre-clinical studies in support of indication selection, including writing project proposals, research plans, and research agreements.
4 Collaborate with clinical researchers/clinical development team (lead clinicians, clinical pharmacology, clinical biomarkers) to provide pre-clinical studies to support indication selection and biomarker strategy, including writing project proposals, research plans, human ethics applications and research agreements.
5 Contribute to writing investigator brochures, regulatory submission, clinical study reports and other documents to support project progression
6 Works with Research Therapeutic Area Lead (RTAL) to develop and implement Research Strategy and to ensure project planning and execution is aligned with TA priorities.
7 Effectively liaises between Research TA Core team and Translational Research team together with key internal functions regarding strategic priorities and project implementation.
8 Provides Research input into early phase NPO due diligence process.
9 Works to build external scientific and industry networks relevant to Immunology TA (working with relevant members of Senior Management in Research function)