GSK
Associate Director, Translational Science/Translational Lead (Renal, inflammatio
GSK, Collegeville, Pennsylvania, United States, 19426
Associate Director, Translational Science/Translational Lead (Renal, inflammation and Fibrosis)
The department of Respiratory, Immunology and Inflammation Translational Unit (RIITU), within the RIIRU therapy area is accountable for end-to-end disease area translational science to inform therapy area and program level biomarker strategies (from preclinical to launch) to increase the probability of success from preclinical to clinical transitions and enable earlier and higher confidence asset related decisions.
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
In this role you will
Lead and/or contribute to developing innovative translational strategies in Renal, Inflammation and Fibrosis assets ranging from preclinical to clinical stage of development. Develop biomarker strategies aligned with clinical development plans to generate data that informs on target engagement, pharmacodynamics, mechanism of action and patient stratification/selection. Represent RIITU at Early Development Team (EDT), Clinical Matrix Teams (CMT) and clinical trial study teams (ST). As part of the CMT and clinical ST, establish clear decision-making criteria to enable biomarker-informed clinical decisions. Provide input on biomarker-related elements of clinical study documentation for study start and reporting of biomarker data generated from clinical trials Provide scientific expertise and technical guidance to enable timely biomarker sample collection and analysis including from high dimensional assays to deliver high quality biomarker data packages to inform clinical development, integrated evidence plan and regulatory strategy. Collaborate with cross-functional teams include biology, translational disease teams, human genetics and genomics, clinical, medical affairs to ensure end-to-end biomarker data generation for asset needs and reverse translation to support the pipeline Why you?
Basic Qualifications & Skills: Ph.D. in a relevant scientific discipline e.g., Cell/Molecular Biology, Genetics, Pharmacology, Physical Chemistry or related field) Experience in translational science and biomarker development in a clinical trial setting within the pharmaceutical or biotechnology industry. Renal, inflammation and / or fibrosis disease area knowledge and understanding in translational/biomarker development and implementation Experience of working in a clinical trial setting, working as part of a clinical study team and experience of authoring and oversight of clinical and regulatory documents Knowledge of regulatory requirements, industry standards, best practices and compliance considerations in Translational Research and biomarker development and validation. Experience in managing external collaborations with academic partners and CROs Strong interpersonal, matrix leadership and communication skills as well as ability to thrive in a matrix environment. Preferred Qualifications & Skills: Demonstrated scientific capability as evidenced by publications, research reports, and external presentations. Up to date knowledge and deep understanding of major molecular and genomic assay technologies and platforms Experience with novel technologies e.g., spatial transcriptomics and AIML GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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Lead and/or contribute to developing innovative translational strategies in Renal, Inflammation and Fibrosis assets ranging from preclinical to clinical stage of development. Develop biomarker strategies aligned with clinical development plans to generate data that informs on target engagement, pharmacodynamics, mechanism of action and patient stratification/selection. Represent RIITU at Early Development Team (EDT), Clinical Matrix Teams (CMT) and clinical trial study teams (ST). As part of the CMT and clinical ST, establish clear decision-making criteria to enable biomarker-informed clinical decisions. Provide input on biomarker-related elements of clinical study documentation for study start and reporting of biomarker data generated from clinical trials Provide scientific expertise and technical guidance to enable timely biomarker sample collection and analysis including from high dimensional assays to deliver high quality biomarker data packages to inform clinical development, integrated evidence plan and regulatory strategy. Collaborate with cross-functional teams include biology, translational disease teams, human genetics and genomics, clinical, medical affairs to ensure end-to-end biomarker data generation for asset needs and reverse translation to support the pipeline Why you?
Basic Qualifications & Skills: Ph.D. in a relevant scientific discipline e.g., Cell/Molecular Biology, Genetics, Pharmacology, Physical Chemistry or related field) Experience in translational science and biomarker development in a clinical trial setting within the pharmaceutical or biotechnology industry. Renal, inflammation and / or fibrosis disease area knowledge and understanding in translational/biomarker development and implementation Experience of working in a clinical trial setting, working as part of a clinical study team and experience of authoring and oversight of clinical and regulatory documents Knowledge of regulatory requirements, industry standards, best practices and compliance considerations in Translational Research and biomarker development and validation. Experience in managing external collaborations with academic partners and CROs Strong interpersonal, matrix leadership and communication skills as well as ability to thrive in a matrix environment. Preferred Qualifications & Skills: Demonstrated scientific capability as evidenced by publications, research reports, and external presentations. Up to date knowledge and deep understanding of major molecular and genomic assay technologies and platforms Experience with novel technologies e.g., spatial transcriptomics and AIML GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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