Senior Program Manager

Title: Associate Director, Program Management (Gene therapy)

Duration: 6 Months

Location: Research Triangle Park, NC

Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.

Description:

The Associate Director, Program Management plays an integral role in advancing client’s 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 development

· Create and maintain integrated development plans that accurately capture timelines, decision points (i.e., stage gates), resource needs, and budget for multiple clinical programs

· Track and coordinate critical activities required to advance programs into early-stage and/or registrational clinical studies

· Provide general operational support to the IPT, including risk identification/mitigation, problem-solving, communication, and contingency planning

· In partnership with IPT lead, ensure the team is prepared for stage-gates and governance interactions, including content development, stakeholder management, and pre-reads

· Deliver 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 items

· Ensure the team communicates effectively and collaboratively, implementing team building techniques where needed to establish and maintain a high-performing teams

· Facilitate creation of program budgets, resource models and long-range plans

· Define resource needs (FTEs and financial) for each stage of development

· Ensure all critical program documentation is organized, accessible, and archived

· In partnership with the PM Center of Excellence, develop, implement, and champion PM best practices, processes, and strategies within the IPT and supporting functions

· Assist with implementation of stage-gates and IPT operating model, including education to the organizations through functional team sessions and meetings with stakeholders/teams

Required Education and Experience

· Bachelor’s degree in a technical or life science discipline

· 5 years of experience within the pharmaceutical/biotechnology industry

· 5 years of project/program management experience

· Excellent written and verbal communication skills with the ability to communicate effectively across disciplines and experience levels, including executive management

· Experience in planning and/or managing cross-functional aspects of biopharmaceutical product development, including translational and clinical studies

· Experience with SmartSheets and/or other project planning/management software

· Ability to mentor, lead, and/or influence partners in a matrixed environment

· Previous exposure to budgeting and resource management processes

Preferred Experience and Skills

· Advanced degree (e.g., Master’s or Doctorate) in a technical or life science discipline

· Project Management Professional (PMP) or an equivalent certification

· Prior experience with developing advanced therapies (e.g., cell or gene therapy)

· Experience working on/with global teams

· Understands and interprets technical data related to biopharmaceutical product development