Jessica Claire
, , 100 Montgomery St. 10th Floor (555) 432-1000,
Professional Summary

Results-driven leader offering severn years of clinical, asset management, and patient care experience. Skilled in building and implementing approaches to increase quality and streamline procedures. Significant leadership background directing multidisciplinary functional teams to achieve corporate objectives and outperform business targets.

  • Decision Quality
  • Collaboration and Communication
  • Partnership Development
  • Team Leadership
  • Risk mitigation
  • SOX, Oxley, Data Integrity & Privacy, FDA
  • Quality Assurance Evaluation
Work History
03/2021 to Current Asset Manager Adobe Systems Incorporated | Berwyn Heights, MD,
  • Asset Manager for late-phase compound (Vadadustat) Program. Key program milestones to date include FDA approval of interventional study protocols (April 20210
  • Leading ACCESS Consortium submission timelines and resources ensuring simultaneous filings with a harmonized defense period.
  • ·Asset Manager for early-phase compound (VIS649), creating and managing timelines and resources that directly support Clinical and Regulatory strategy and operations. Key achievements include successfully launching Clinical Regulatory Team (CRT); monthly forum aligning clinical and regulatory activities for program priorities and issue escalation. Current key assignment includes managing timelines and cross-functional stakeholders for IND Submission January 2022.
  • Key contributor for Otsuka's Target Product Profile (TPP) Strategic Development Tool Initiative, which is focused on re-designing Otsuka’s TPP, in order to be used as a decision-driving strategic roadmap. Responsibilities included defining late-stage TPP requirements with input from key subject matter experts (SMEs) and creating the Late-Phase TPP template to support overall project delivery.
10/2019 to 11/2021 Asset Manager Adobe Systems Incorporated | Akron, OH,

Lead Asset Manager for the global early-phase Epilepsy Clinical Program

Successfully achieved (met or exceeded) 2019 and 2020 Corporate R&D Goals.

  • Complete all planned Phase 1 studies on time on budget.
  • Successfully executed on program milestones (corporate goals and operational activities such as protocol approval and regulatory activities), despite logistical challenges due to Covid-19 pandemic
  • Successfully launched first-ever internship program for the Portfolio Strategy and Asset Management Department; onboarding four summer interns, two of which have now been chosen for hire.
01/2017 to 10/2019 IT Quality and Reporting Manager Otsuka Pharmaceutical Development & Commercialization | City, STATE,
  • Project Manager for the Otsuka & Harvard School of Public Collaboration, a project focused on the indoor environment and impact to public health; this project resulted in a successful readout to internal senior leaders to inform corporate strategy.
  • Served as the support lead for IT Quality and Compliance: External Audits, regulatory inspections, audit response & evaluation, and reporting/communication on education & learnings.
  • Quality lead for IT Adherence/Compliance (Delivery): Policies and standards, Compliance within delivery (projects), GxP, JSOX, data privacy, and vendor quality.
  • Quality lead for IT compliance and risk Management: Implementing corrective actions on process deficiencies, education for project and business teams understand the quality processes.
05/2013 to 12/2016 Corporate Projects Lead Otsuka Pharmaceutical Development & Commercialization | City, STATE,
  • Responsible for implementing innovative solutions within clinical research and digital medicine to support good clinical practices and regulatory compliance.
  • ·Served as a liaison between various corporate initiatives such as enhancing investigator training, development of eModules, implementation of eConsent in clinical trials, and working to create scientific medical animation videos to be used for patient education.
  • ·Collaborated with members of the clinical development team such as executive management, medical monitors (physicians), clinical research associates, and IT personal to meet corporate deliverables.
  • Co-Lead in the successful implementation of novel solutions (e.g., eConsent, eSource, eScanning, etc) to improve Clinical trial efficiencies and increase OPDC's probability of clinical and regulatory success.
  • Served as the eConsent Business Lead in support of the ePlatform initiative, providing guidance & training for new teams using eConsent
  • · Served as lead for eConsent integration and implementation to include working closely with Quality and Legal functions on eConsent from a privacy and regulatory perspective.
  • Serve as a change agent with clinical sites, CROs, and internal teams on promoting adoption, technical support and training.
  • Project Lead on Princeton University Genomics Collaboration with Otsuka Think Team and Data Sciences. Ensuring functional area personnel (Clinical, pharmacologist, etc.) ensuring necessary team members are engaged and are actively contributing, to evaluate results and make decisions.
  • Served as OPDC PORT (Protocol and Outline Review Team) Administrator to develop electronic efficiencies within PORT process as well as develop strong communication strategies between Clinical Teams and PORT stakeholders.
  • Key contributor/lead on Digital Health System collaboration with Proteus Health (NDA submitted to FDA September 2015). Supporting all major clinical trial deliverables (ethic/IRB submissions, trial start up, data cleaning, etc).
  • Key contributor for the “Business Intelligence” committee, seeking out business opportunities (e.g. vendor partnerships, technology platforms & solutions) to improve the overall operation for clinical trials across OPDC.
Expected in 12/2017 Master of Science | Public Health Rivier University, Nashua, NH GPA:
Expected in 05/2014 Bachelor of Science | Nursing Rivier University, Nashua, NH GPA:

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