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Program Manager

LanceSoft Inc

Durham, NC

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JOB DETAILS
JOB TYPE
Full-time
LOCATION
Durham, NC
POSTED
24 days ago
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 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

About the Company

L

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

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.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/

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