Program Manager

The Associate Director, Program Management plays an integral role in advancing gene therapy products through clinical development. They will provide comprehensive program management and operational support for the Integrated Product Team (IPT), including creation and maintenance of integrated, end-to-end development plans and timelines. This role partners with the IPT Lead to ensure the program team has clear direction and alignment to execute critical activities ranging from pre-clinical (IND-enabling) studies up through BLA submission (e.g., CMC, regulatory, clinical, medical).Responsibilities:In partnership with the IPT Lead, define scope, objectives, and deliverables for product candidates in stages of clinical developmentCreate and maintain integrated development plans that accurately capture timelines, decision points (i.e., stage gates), resource needs, and budget for multiple clinical programsTrack and coordinate critical activities required to advance programs into early-stage and/or registrational clinical studiesProvide general operational support to the IPT, including risk identification/mitigation, problem-solving, communication, and contingency planningIn partnership with IPT lead, ensure the team is prepared for stage-gates and governance interactions, including content development, stakeholder management, and pre-readsDeliver timely updates to key functional stakeholders, leadership, and governance boards covering program status, risks/mitigation, scope changes, etc.Document IPT meeting minutes, key decisions, risks/issues, and action itemsEnsure the team communicates effectively and collaboratively, implementing team building techniques where needed to establish and maintain a high-performing teamsFacilitate creation of program budgets, resource models and long-range plansDefine resource needs (FTEs and financial) for each stage of developmentEnsure all critical program documentation is organized, accessible, and archivedIn partnership with the PM Center of Excellence, develop, implement, and champion PM best practices, processes, and strategies within the IPT and supporting functionsAssist with implementation of stage-gates and IPT operating model, including education to the organizations through functional team sessions and meetings with stakeholders/teamsRequired Education and Experience:Bachelor's degree in a technical or life science discipline5+ years of experience within the pharmaceutical/biotechnology industry5+ years of project/program management experienceExcellent written and verbal communication skills with the ability to communicate effectively across disciplines and experience levels, including executive managementExperience in planning and/or managing cross-functional aspects of biopharmaceutical product development, including translational and clinical studiesExperience with SmartSheets and/or other project planning/management softwareAbility to mentor, lead, and/or influence partners in a matrixed environmentPrevious exposure to budgeting and resource management processesPreferred Experience and Skills:Advanced degree (e.g., Master's or Doctorate) in a technical or life science disciplineProject Management Professional (PMP) or an equivalent certificationPrior experience with developing advanced therapies (e.g., cell or gene therapy)Experience working on/with global teamsUnderstands and interprets technical data related to biopharmaceutical product development