• Director, Post Trial Supply

    BeOne Medicines (Emeryville, CA)


    General Description:

    This role will focus on providing Post Trial Supply (PTS) Access to patients exiting a BeOne parent protocol who are eligible for continued patient access to BeOne medicines through the Patient Programs/PTS route. This is a global role that will work cross functionally within BeOne to ensure adherence to the PTS process.

    Patient Support Programs (“Post-Trial Supply”):

    + Lead the Post-Trial Supply activities across Global Clinical Operations Trial portfolios/compounds as needed/established.

    + Establishing and follow new or revised GCO policies and procedures for PTS SOP.

    + Work with the PTS GCO Leader- ensure cross functional team members are provided with appropriate vision, direction, training, and support to ensure PTS access as needed and where regulatorily allowed by region/country.

    + Support the PTS GCO Leader to build up and maintain Post-Trial Supply Governance Board aimed at driving PTS access across our portfolio, countries, and regions as needed.

    + As the PTS Lead- partner with key stakeholders and external partner vendors in ensuring proper execution of PTS access programs and solutions are aligned with country level regulations.

    + With support from the PTS GCO Leader, develop, establish, and report post-trial supply related metrics (KPIs/KQIs), tools and training materials for optimal change management within BeOne organization.

    + Lead or co-lead the Identification of emerging regional/country/ regulatory risks or concerns related to the roll-out and execution of Post-Trial Supply programs.

    + Work with regional team to drive exploration and set up country level solution to meet company financial excellence

    + Use appropriate measurements, analysis and evaluation methods to accurately identify and document process improvements.

    + Review upcoming and ongoing portfolio/compound activity for PTS forecasting needs in BeOne CTMS

    Qualifications:

    + Bachelor or higher degrees (life science preferred, including medicine, nursing, biology and laboratory technology)

    + 10+ years of experience in research and development,

    + Post Trial Experience is required

    + Excellent interpersonal skills, strong organizational skills, and effective written and verbal communication skills.

    + Evidence of team leadership capabilities

    Computer Skills:

    + Microsoft Office Suite, Excel, PowerPoint, Word, etc. DocuSign Other

    Travel:

    + Minimal to none except if department wide face to face is needed.

     

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.