● Expand project management skillset by leading the development of revised sNDA timelines and documenting outcomes of project-related discussions.● Collaborate with 6 cross-functional teams to identify responsibilities, resources, and deliverables to support sNDA submission to the FDA.● Lead for eCTD Module 1 sub-team. ● Assist in coordinating 3 FDA meetings and preparing meeting materials. ● Summarize regulatory milestones, progress, and emerging issues to project teams.● Participate in regulatory initiatives aimed at improving internal regulatory processes.

● Provide regulatory project management support for sNDA planning by managing the timelines, core filing team review matrix, and central outlook calendar. ● Assist in assessing risks and contributing proposals to mitigate risks identified.● Assist in coordinating 3 FDA meetings and preparing meeting materials.● Collaborate with 6 cross-functional groups to develop work-streams, project plans, and target completion dates necessary for successful regulatory submissions.● Mentor Regulatory Affairs fellows.

● Regulatory representative for 2 early and 1 late phase oncology clinical trials, ensuring successful and compliant execution of trials. ● Lead the preparation, review, and timely submission of regulatory dossiers as required for investigation products in the U.S. and abroad (Orphan Drug Designation).● Effectively collaborate with 3 external regulatory consultants/CRO’s as required.

● Assist in developing and implementing strategies for the earliest possible approvals of regulatory submissions associated with assigned projects.● Assist with the preparation, review, and timely submission of regulatory dossiers as required for investigation products in the US and abroad.● Maintain regulatory archive across 2 early and 1 late phase oncology clinical trials.

● Design and execute cell signaling assays (qPCR and luminescence).● Troubleshoot and optimize in vitro cell assays (western blot, Q-PCR, soft agar) in support of 2 oncology programs.● Generate and maintain cell lines for in-vitro screening studies (stable/transients cell line generation, RNAi/shRNA study). ● Assist and train research associates on in-vitro cell assays and techniques

● Identify and characterize compound potency form in-vitro cell lines, in-vivo mouse models, and primary patient samples (tissue processing, western blot, Q-PCR, soft agar). ● Conduct synthetic lethal screening in collaboration with drug discovery groups (large scale cell culture, virus library infection, validation by western blot, and proliferation assays).

Molecular Biology Department of the Biomarker and Personalized Medicine (BPM). ● Study gene expression changes in multiple in vitro cancer cell models treated with drug compounds (cell culture, compound treatment, and RNA extractions). ● Measure the effect of PARP inhibitor in combination with temozolomide (TMZ) by measuring protein levels from patient plasma samples (ELISA assay).

Department of Cancer Biology● Study the chronic induction of PIK3CA-H1047R in genetically engineered mice (qRT-PCR, carmine staining of mammary glands, and western blot analysis).● Assist in identifying the serine-threonine kinase, SIK1, as a regulatory of p53-dependent anoikis by a kinome-wide shRNA screen.