Kyle Doctor Email & Phone Number

Rockville, Maryland, United States

- Coordinate the input, planning, and attendance of task force members, Congressional staff members, and multiple internal departments, within the guidelines of the Senate Ethics Committee, to positively execute a briefing on Capitol Hill to address drug shortages and offer recommendations to tackle the crisis.- Support standing up the pilot phase of a novel testing program by capturing potential stakeholder engagement and impressions to determine direction, scope, and mechanics. Additionally, arrange a launch event at USP’s headquarters with external stakeholders to elaborate the importance of this program and onboard other participants to the pilot program.- Oversee the development and organizing efforts of multiple concurrent workstreams to successfully fulfill USP's governance objectives at the 2025 Convention Meeting by introducing a project management rigor around appropriate resourcing, fostering two-way lines of communication, and precise project metrics tracking to establish productive accountability among internal and external stakeholders.- Develop fit for purpose key performance indicators (KPIs) and project management tools and processes to properly track and maintain complex projects to better understand and improve stakeholder engagement.

Gaithersburg, Maryland, United States

- Coordinated Chemistry, Manufacturing, and Controls-related, otherwise known as CMC, activities with departmental heads, subject matter experts (SMEs), and external clients to produce GMP-level lentiviral vectors (LVVs) containing client gene of interest as a form of cancer immunotherapy. This was accomplished by translating business strategy documents into project objectives, work plans, resource assessments, timelines, budgets, as well as identifying and mitigating any potential risk scenarios.- Composed and presented detailed project work plans that outlined LVV manufacturing process, QC testing specifications, QA documentation requirements, and accelerated and real-time stability study timepoints; and revised project work plans to meet changing industry and client standards.- Supported client Biologics License Application (BLA) submissions to FDA for LVV commercial use by confirming that source documentation was complete, current, and aligned; while maintaining an on-going lessons-learned directory to streamline future BLA submission procedures.- Developed and communicated clear performance expectations, established open feedback channels to improve day-to-day operations, monitored Key Performance Indicators (KPIs) to ensure that all deliverables were completed on-time and in-full (OTIF), and escalated process deficiencies to resource managers.- Advised on forecasting efforts of LVV manufacturing runs (valued at $1M+ per run) to optimize portfolio capacity by informing key internal and external senior stakeholders of critical clinical, manufacturing, QC reporting, and stability testing milestones.- Ensured the precision and accuracy of all interdepartmental findings and results by reviewing client- and project-specific release paperwork, Batch Production Records (BPRs), and global Standard Operating Procedures (SOPs); and supporting the resolution of any out of specification (OOS) or out of trend (OOT) investigations.

Rockville, Maryland, United States

- Collected, collated, and cross-referenced data related to all EPTM projects and initiatives from internal and external Otsuka functions and partners, while maintaining good working relationships to foster positive interactions to ultimately support Otsuka’s long-term strategic goals.- Prepared and maintained up-to-date project-level deliverable information to the EPTM group, the EPTM group VP, and the wider Otsuka organization, to enable concise strategic long-term decision-making.- Supported EPTM members in the review, preparation, and development of project proposals, while ensuring appropriate follow through to achieve approved program/project objectives.- Communicated between the Otsuka Finance division and the respective Functional Area leads to review and accurately estimate monthly forecast reports against spending trends to support project prioritization to align with corporate budgetary goals.- Generated process workflows and visualizations to improve the efficiency of advancing protocol review processes, the contracting and payment of suppliers/vendors, and the consulting efforts of scientific key opinion leaders (KOLs).- Organized and hosted internal- and external-facing EPTM meetings to align on project timelines and objectives with other Otsuka departments such as Portfolio Strategy and Asset Management (PSAM), Clinical Management, Global Regulatory Affairs, as well as other Otsuka partner companies.- Facilitated the on-boarding process of new team members that addresses the rapidly expanding body of work; identifying and tracking both cross-project and cross-functional risks and issues related to project scope, timeline, and budget.

Rockville, Maryland, United States

Rockville, Md

- Applied PM techniques and concepts to effectively organize, schedule, and budget cross-functional activities of internal resources throughout the lifecycle of a study to ensure that project activities and deliverables met timeline and quality obligations, were in compliance with internal SOPs and other regulatory requirements for clinical trials, and fulfilled all Sponsor team’s requirements.- Established milestone events and coordinated startup activities with Sponsor and internal teams through kickoff meetings; including study documentation drafting, systems setup, site enrollment tracking, and the provisioning of ECG equipment and supplies to domestic and international sites relative to Sponsor team’s study requirements.- Operated as the main POC for 17 assigned studies with a budgetary value of $5.4M, and provided weekly project status report trackers for each study that detailed milestone activities, study metrics, site qualification statuses, patient and data tracking, site-specific data discrepancies; as well as any study-, personnel-, or site-related announcements/issues.- Hosted and/or participated in regularly scheduled study status meetings to discuss agenda items such as timeline updates, study metrics, site qualification status, data discrepancy solutions, or potential risk mitigation strategies; which were all documented in meeting agenda and meeting minute documents that were provided to the Sponsor team in a timely manner.- Assessed any changes in study scope related to resources, timelines, or deliverables and drafted Change Request documents for internal and Sponsor team review that covered the financial and/or scheduling impacts, the reasoning of the impacts, as well as the necessary actions to implement the change request.- Attended and represented BioTel Research at Sponsor-held Investigator Meetings and CRO trainings to ensure familiarity and efficiency with study-specific processes throughout study startup, maintenance, and closeout.

Menlo Park, Ca

- Identified client expectations, then devised and implemented appropriate project activities and timelines for cross-departmental functional groups required for preclinical, IND-enabling studies.- Coordinated pre-study planning action items for all involved scientists/analysts, including completing Study Director Assignment forms, submitting test article requests, and ensuring that all necessary facilities and equipment were reserved.- Assured the timely submission of raw in-life data from various technical groups and the completion of any internal or 3rd party experimental analyses to maintain complete study records and client-set deadlines.- Facilitated the composition and quality assurance review of Chemistry, Manufacturing, and Control (CMC) biopharmaceutical research reports and ensured they met Section 508 accessibility standards.- Set up and lead monthly status meetings and provided notetaking assistance to ensure that ongoing research efforts maintained project scope and accuracy, while following up on any client queries.- Compiled monthly, semi-annual, and annual program status reports and financial summaries, while monitoring spending reports and invoice submissions.- Reviewed regularly updated SOPs, attended SRI training seminars and outside project management courses, as well as created project management training documents to improve day-to-day operations.

San Francisco, Ca

- Supervised diverse project scopes with budgets ranging from $10,000 to $100,000 while communicating between full-service vendors, quality assurance testers, packaging designers, in-house team members, and stakeholders for higher education divisions such as Anatomy & Physiology, Physics & Astronomy, Health & Nutrition, and Geology.- Developed and organized planning and production documents, budgets, and schedules for up to 18 concurrent digital and physical media products, each consisting of 4,000+ JPEGs, 3,000+ PowerPoint slides, and 100+ multimedia resources, while ensuring proper functionality across various operating systems.- Mitigated project deviations by implementing necessary production changes in order to preserve planned in-stock or go-live dates while operating within budget constraints and quality standards.

San Francisco, Ca

- Connected with acquisition, project, and development editors to arrange, conduct, and manage textbook reviews for upcoming majors, non-majors, and graduate-level physics and astronomy textbook revisions.- Set up and maintained program and component records in multiple internal record systems to provide insight into editorial assistant responsibilities during Pearson’s workflow restructuring to improve operational efficiency.

San Francisco, Ca

- Assisted in the content and technical development of Practice Anatomy Lab 3.0, one of Pearson’s successful revenue-generating virtual laboratory aids.- Collaborated with PAL 3.0 team members to generate spreadsheets, edit manuscripts, and proofread templates used by authors, in-house staff, and third-party vendors in accordance with budget and schedule obligations.- Additionally supported other media producers with the production of new editions or versions of existing online and print media in various science disciplines.

Moraga, Ca

- Accountable for the organization of large volumes of high- and low-priority incoming packages and their delivery to appropriate departments in a reliable and timely manner.- Additionally, determined affordable and timely shipping methods for outgoing letters and packages despite budget cuts mandated throughout the campus.

Moraga, Ca

- Responsible for intercollegiate game operations tasks, including management of student staff employees and sports facilities, coordination with home and visiting NCAA Division I teams, and facilitation of customer service conflicts in order to improve pre- and post-game operations.- Coordinated efforts with various athletic department staff members, campus security personnel, student body, and community fan base to provide unrivaled sporting event experiences.- Assisted in various aspects during the appearances of the men’s basketball team in the 2009 NIT and 2010 NCAA Basketball Tournaments, the women’s basketball team in the 2010 NIT Tournament, and the women’s volleyball team in the 2009 NCAA tournament.