Sr. Program Manager

Milestone has a need for a Sr Program Manager that can manage a large Program that needs to be road-mapped refreshed manage multiple workstreams and hold the leads accountable In addition manage and identify risks and issues and work with the team to address and close such issues and risks The Sr Program Manager will work closely with the Lead Architect the team s and is accountable for the overall management of the initiative Currently an assessment review of options solutions and the creation of an business case recommendation has been kicked off by the client with the expectation the Sr Program Manager will take over these initial workstreams and manage to completion Program Leadership Lead end-to-end program execution for one or more programs or product lines including planning scheduling risk management and reporting Cross-functional Integration Partner with functional leads across R D Technology Regulatory Affairs Quality Manufacturing and Commercial to align on milestones resource allocation and deliverables Governance and Communication Facilitate program governance meetings provide regular status updates to executive leadership and stakeholders Deliver high-quality executive-level updates dashboards and presentations to senior stakeholders and steering committees Timeline and Budget Management Develop and manage integrated project plans timelines and budgets track progress and proactively address risks and issues Maintain accurate budgeting and forecasting tracking expenditures and managing financial risks in partnership with finance teams Regulatory and Compliance Oversight Ensure programs adhere to GxP ICH and FDA EMA other applicable regulatory requirements throughout all phases Lifecycle Planning Support product development strategy regulatory submissions clinical trial planning and launch readiness activities Stakeholder Engagement Act as a key liaison between internal teams and external partners including CROs CDMOs and regulatory bodies Manage multi-vendor engagements including contract negotiation performance oversight and SLA adherence Provide deliverables not limited to on a timely cadence Project Charter Business Case Program Project Schedules Plans Status Reports Communication Plans Meetings Announcements Stakeholders etc Meeting Minutes RAID Log Qualifications Needs to have the experience and composure to be the single point of contact on all workstreams and is expected to provide guidance on all things supporting this program including knowing and providing answers or if not can quickly and effectively find the answers Preferences Experience in Risk Issue Mitigation Mgmt strategies and impacts to project Working knowledge of SAFe Agile frameworks to be able to effectively work with the Scrum Master and Product Owner Bachelor s degree in life sciences engineering or related field Master s or Ph D preferred 8-12 years of program project management experience preferably in the pharmaceutical or biotechnology industry Proven track record of leading complex cross-functional drug development programs Strong understanding of regulatory pathways clinical development and commercialization processes PMP certification or similar credentials preferred Excellent communication presentation and leadership skills Proficiency with project management tools e g MS Project Smartsheet Planisware etc Regulated and GXP GLP GMP Experience preferred Regulated Domain Experience in a Life Sciences company Familiarity with data governance cybersecurity or enterprise systems e g ERP CRM in the pharma industry is a plus Tools Jira Smartsheet Confluence MS Teams SharePoint MS Office 365 Excel Powerpoint Sharepoint Teams Word Miro