Responsible for identifying and defining process improvements, including the oversight, planning, and strategy for implementation to the business. As a key member of project and compound teams, provide scientific contributions to clinical trials, focusing on efficiently driving task completion while ensuring high quality. Strategically aligned our department’s operational policies and procedures to business objectives using available technology, resulting in enhanced productivity across all groups in our organization.• Lead, drive efforts and fully implement innovative process improvements based on technology that have increased efficiency in clinical pharmacology trial execution. Efforts have resulted in decreased end-to-end timelines and an enhanced end-user experience. • Extensive experience and proficient in the operations and program management of Phase I clinical trials, including (but not limited to): timeline management, site selection, oversight of study conduct, site initiation activities, clinicaltrials.gov study entry, etc. Extensive experience and proficient in end-to-end Phase 1 clinical trial activities, including (but not limited to): development of clinical trial protocols, contribution to data management activities (e.g., case report forms, laboratory initiation and set-up, data transfer specifications and agreements, clinical database development), clinical pharmacology data analysis (e.g., pharmacokinetic, pharmacodynamic, biomarker, etc.), and development of clinical trial study reports. Over 100+ clinical trials supported.• Extensive experience and proficient in the preparation of regulatory submission documents and modules as they relate to clinical pharmacology (e.g., NDA, MAA, Labeling, etc.). • For Phase II to IV, participate in the operations and program management of, support the development of clinical trial protocols, perform clinical pharmacology data analysis, and contribute to the development of clinical trial study reports.

• Collaborate with project leaders and external stake-holders to actively participate in the overall clinical development strategy and design of clinical pharmacology studies. Act as a liaison between global internal and external stake-holders, ensuring cross-functional partnerships are successful, and all parties work together in bringing projects to completion.• Competent in the operations and program management of Phase I clinical trials, including (but not limited to): timeline management, site selection, oversight of study conduct, site initiation activities, clinicaltrials.gov study entry, etc. Competent in in end-to-end Phase 1 clinical trial activities, including (but not limited to): development of clinical trial protocols, contribution to data management activities (e.g., case report forms, laboratory initiation and set-up, data transfer specifications and agreements, clinical database development), clinical pharmacology data analysis (e.g., pharmacokinetic, pharmacodynamic, biomarker, etc.), and development of clinical trial study reports. Over 100+ clinical trials supported.• Competent in the preparation of regulatory submission documents and modules as they relate to clinical pharmacology (e.g., NDA, MAA, Labeling, etc.). • Develop and author abstracts, posters at conferences, and publications in peer reviewed journals.

• For clinical trials in all phases of development (Phase I, II, III, and IV), perform pharmacokinetic, pharmacodynamic, and/or pharmacokinetic/pharmacodynamic analysis and prepare summarize results. Prepares these results for Summary Overviews, Clinical Study Reports, Data Communications and Regulatory Submissions. • Participate in scientific working groups with cross-functional/cross-departmental scope to provide input regarding project or submission deliverables.• Develop and author abstracts, posters at conferences, and publications in peer reviewed journals.

• For Phase I clinical trials, perform pharmacokinetic, pharmacodynamic, and/or pharmacokinetic/pharmacodynamic analysis and prepare summarize results. Prepares these results for Summary Overviews, Clinical Study Reports, Data Communications and Regulatory Submissions. • Participate in scientific working groups with cross-functional/cross-departmental scope to provide input regarding project or submission deliverables.