Jennifer Ott Email & Phone Number

Cleveland, Oh, Us

Cleveland, Oh, Us

Indianapolis, Indiana, Us

Stamford, Ct, Us

Defined bioanalytical operational oversight process for phase 1 clinical and clinical pharmacology oncology trials within new role in clinical operations group. Responsible for the planning, execution and monitoring of clinical bioanalytical activities. Developed expedited sample management plans, partnered on lab kit/manual development and resolved issues at site, CRO and vendor level regarding clinical bioanalytical work. Execute strategies for managing multiple vendors to ensure quality driven work and partner effectively with clinicians, scientists and vendors to succinctly execute lab deliverables.

Indianapolis, Indiana, Us

• Primary point person for outsourced in vitro studies investigating potential DDI clinical interactions for small and large molecule candidates. Provide key scientific leadership on study design proposal, vendor contract agreements, and results/report acceptance. Manage capacity at multiple vendors to ensure timely study completion for internal departmental and regulatory needs.• Lead, moderate and facilitate interactions with outsourcing partners on key study deliverables to leverage collaborative efforts. Generate metrics capturing the movement of work from start to finish with vendors on completion timeliness and conduct capacity planning activities to meet study demand. • Ensure external vendors maintain high data standards, secure archival processes, thorough notebook documentation and meet guidelines set forth by FDA regulations for lab operations. Conduct routine check-up meetings with external lab partners and conduct oversight audits on-site as needed.

Indianapolis, Indiana, Us

Designed, coordinated and interpreted preclinical ADME (in vivo, in vitro and/or metabolism) studies for various therapeutic discovery platforms. Prepared detailed reports/power point presentations for distribution among team members in assistance of scientific decisions regarding potential clinical outcomes based upon discovery results. Leveraged research expertise to successfully deliver results to discovery teams and assert confidence in ADME project leader role. Independently analyzed and presented ADME data to make informed decisions regarding SAR progression. Diligently assessed and researched the potential liability for clinical drug interactions based upon in vitro data to generate risk profiles for compounds using the SimCYP modeling program. Over 15 projects were reviewed spanning from late discovery to early clinical development. In some cases, these modeling efforts provided a path forward regarding dosing strategies for a discovery compound for movement into clinical development when alternatives did not exist. Developed and applied a structured report format for SimCYP modeling results for submission to regulatory agencies. Co-author on publication comparing SimCYP predicted assessment to clinical outcome.

Indianapolis, Indiana, Us

• Conducted laboratory procedures in support of the development, validation and execution of assays used to determine pharmacokinetic properties of discovery therapeutics. • Core contributor for discerning optimal preclinical report writing processes for discovery reports (Brand Champion Award, 2004).• Developer and process owner of Quality Assurance process for reports and documents submitted to internal governance committees (Quality Advocate Award, 2005). • Served as QC reviewer of ADME reports submitted to internal and/or global regulatory agencies. • Provided oral and written presentations on ADME data to internal project teams, internal/external departmental meetings, and internal/external scientific conferences.• Developer of screening assay used to assess the potential for discovery compounds to form glucuronides in vitro (work presented at AAPS in 2006).

Master'S Degree, Biology/Biological Sciences, General

Ba, Biology