Kathleen Sotelo Tran

Biotech Program Leader | CMC & Clinical Development | PMO Strategy & Execution

San Francisco Bay Area

About

With over a decade of experience helping biotech and pharmaceutical programs move from strategy to execution, the work behind the work is what drives me: building the governance, alignment, and momentum that allow scientific teams to focus on what matters most: advancing therapies to patients. I work at the intersection of technical operations and cross-functional execution, supporting late-stage pipeline development in the oncology space. My focus is bringing structure and clarity to complex CMC workstreams, from tech transfer and clinical readiness to supply chain alignment and regulatory milestones. My background spans the full spectrum of the industry, from large CDMOs like Catalent and CROs like Intertek, to lean sponsor-side teams at Alkahest and Galapagos. Each experience has sharpened my ability to lead programs that are both rigorous and adaptive, and to build the operating cadences, cross-functional alignment, and executive visibility that keep high-stakes programs on track.

Experience

  • US Project Lead - Site Management at Galapagos
    Sep 2024 - Present · 1 yr 10 mos

  • Project Manager II at Alkahest, Inc.
    Sep 2020 - Sep 2024 · 4 yrs 1 mo

  • Project Manager at Miltenyi Biotec
    Sep 2019 - Sep 2020 · 1 yr 1 mo

    Served as the primary project manager for 5+ major accounts, facilitating technology transfers to a new facility, ensuring timely regulatory submissions, and overseeing a successful transition to the next stage of manufacturing. • Collaborated with project team leaders to develop and maintain comprehensive project plans and trackers, ensuring alignment on execution and resource allocation. • Facilitated cross-functional meetings with internal and external departments to synchronize project execution, regulatory strategies, and tech transfer planning. • Led the creation and standardization of tools for the Project Management Office (PMO), enhancing project management capabilities. • Pioneered client-focused communication strategies and implemented best practices to strengthen and sustain client relationships, while managing site selection, tech transfer phases, and regulatory submissions.

  • Project Manager at Catalent Pharma Solutions
    Jun 2018 - Sep 2019 · 1 yr 4 mos

    Served as the primary liaison with clients, managing portfolios across multiple Catalent sites globally. • Cultivated strong client relationships through effective lifecycle management, building trust, and identifying strategic clinical development opportunities, enhancing market presence and revenue. • Secured new business and expanded project scopes, contributing to revenue growth and strengthening Catalent’s market position. • Developed and managed project timelines, facilitated internal collaboration, and led client meetings, resulting in on-time project delivery, improved internal coordination, and an increase in project efficiency and client satisfaction. • Utilized project management software (Orchestrate, MS Project, Smartsheet) to track progress, enhance communication, and align regulatory compliance, budgets, and clinical planning with business objectives.

  • Project Manager, Client Services at Intertek
    Nov 2016 - Jun 2018 · 1 yr 8 mos

    Served as the primary client contact for all assigned projects, ensuring consistent client satisfaction. Managed and tracked over 15 clients with projects in both clinical and non-clinical phases. • Leveraged Microsoft Project and Smartsheets to develop and implement structured project trackers, meeting agendas, and minutes, enhancing project oversight and communication efficiency, which resulted in a 30% improvement in project tracking accuracy and a 20% reduction in meeting preparation time. • Delivered weekly revenue forecasts and client pipeline reports to senior management, supporting informed decision-making and strategic planning. • Developed and implemented financial forecasting and account reconciliation templates, enhancing overall financial accuracy and ensuring billing precision for projects. • Initiated and led the adoption of new processes, including a sample management tracker, complement of the LIMS, resulting in a 75% increase in sample processing from initial receipt to analysis. • Improved project timeline accuracy by using the Smartsheet lab scheduling tool for analysts, ensuring effective resource allocation to meet deadlines.