The department of ITGR/OMNI Biomarker Development within Development Sciences spans from drug discovery through Phase III clinical trials to support the development of novel therapeutics for unmet medical needs. We use relevant biomarkers to evaluate target-engagement, mechanism of action, and disease modification and guide clinical diagnostic biomarker development. Our department is responsible for developing biomarker strategies, designing and implementing biomarker assays, and interpreting biomarker results. Biomarker team leaders within the department provide scientific leadership for biomarkers for clinical trials ranging from early proof-of-concept through global Phase III. We are currently seeking a highly motivated scientist to provide PD and diagnostic biomarker support on both small molecule and biologics projects in Ophthalmology.
The primary responsibility for this individual will be supporting diagnostic biomaker development for clinical trials in ophthalmology. The individual will be responsible for leading internal research and coordinating external collaborations to further our understanding of biomarkers related to disease progression and treatment response, with a focus on genetics and retinal imaging. Success in these responsibilities requires a thorough understanding of disease and drug target biology, creativity and attention to detail to develop novel biomarkers, and a pragmatic approach to integrating biomarkers into clinical trials. The position requires working in close partnerships across various functions including Research, Preclinical PK, Clinical Pharmacology, Bioanalytical Assays, Diagnostics Discovery, Companion Diagnostics, Clinical Sciences, Biostatistics, and Regulatory. This individual will serve as the biomarker representative on cross-functional project teams and lead Biomarker Subteams that integrate all biomarker activities for projects in Development. Responsibilities also include leadership, management and prioritization of internal and outsourced lab work across multiple projects to insure timely and informative analysis of results. Effective communication is essential and includes presentations at cross-functional teams, internal review committees, and external conferences. The position also involves writing biomarker sections of clinical protocols, reports, regulatory filings and scientific publications. In addition, the individual is expected to establish and manage productive collaborations with academic researchers and contribute to the scientific community by publishing results in high quality journals.