Job Description

Description:
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