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Role Summary
Responsibilities
Partners with Program Lead to drive the cross-functional alignment and delivery of assigned programs.
Provides program management leadership by providing active input into the project strategy & vision, ensuring alignment of the project strategy with operational delivery.
Leads teams in the creation of comprehensive development and launch plans, including identifying alternatives and scenario planning in corporation with other functional areas.
Leads teams to develop and manage marketing authorization submissions to health authorities and overall cross-functional launch/new product introduction to the Commercial organization.
Partners with all functional areas (e.g. pre-clinical, manufacturing, regulatory, clinical, safety, data management) to refine and build integrated program strategy and timelines, identify the critical path and keep the programs on track.
Ensures appropriate linkages between project strategy and key internal processes (therapy area strategies, prioritization, resource management, corporate scorecard, etc.).
Works with the program team to establish short and long-term goals and proactively identifies issues and/or risks; facilitates risk mitigation strategies where needed.
Coaches project teams towards successful issue resolution and decision making and focuses the team on the right activities at the right time; able to handle most challenging project situations.
Monitors deliverables and communicates regular updates of program status to stakeholders via dashboards, program reporting and other cross-portfolio project management tools.
Completes day-to-day program management activities, such as facilitating cross-functional team meetings, leading discussions to drive decision-making, preparing agendas and meeting minutes, and defining and resolving action items.
Partners with the Program Lead and project team members to develop impactful presentations which summarize complex topics into critical points to facilitate strategic planning and decision-making and prepares programs status updates and governance presentations to the governance committees.
Ensures that all key stakeholders are knowledgeable of program milestones, plans, program status and decisions through regular reporting and communication.
Ensures the team and stakeholders have the right information for decisions and leads the team through problem solving, decision discussions and contingency planning, particularly with respect to complex and unique issues.
Upholds excellent program management best practices and principles while serving as a visible leader to strengthen the program management department and create efficiencies where possible.
Provides guidance regarding standards/templates to Program Lead, the project team and senior management/governance bodies that allows efficient (timely and informed) decision making.
Working with the Program Lead, uses broad influential network and ensures engagement at all levels prior to key decisions to ensure alignment on key questions/decisions which need to be made.
Ensures that overall team deliverables, budgets, schedules, and performance standards are realistically set, governance-approved and successfully attained, and that the project effectively fulfils all business reporting requirements.
Champions company program management methodologies and adoption of new project management practices; can drive and execute programs.
Uses business knowledge to drive cross-project learning, champion and embed better ways of working across the company through influence.
Assists the VP, Program and Portfolio Management, and other team members as required, in process improvements and other initiatives to improve organizational effectiveness; leads departmental initiatives as requested.
Qualifications
Educated to BS/ BA level or higher in life science discipline or equivalent
Typically requires a Bachelor's degree and 16+ years of related experience; or equivalent experience.
Masters/ PhD/ PharmD/ MBA in immunology, biochemistry, cell biology or related discipline
Prior experience in BLA/MAA filings and new product launch.
PMP certification preferred but not required
Experience
Experience in the biotech/pharmaceutical industry with prior experience in an R&D Project or Product Management role in the Biotech industry (at least 12+ years of relevant experience)
Extensive knowledge of late-stage R&D drug development processes within the Pharmaceutical and/or Biotech industry
Proficiency with MS Project/Smartsheet and/or other PM tools and practices
Ability to empower, lead and encourage efficient cross-functional teams
Excellent working knowledge of project management tools and processes
Strong organizational and time management skills
Familiarity with Microsoft environment (Word, Excel, Power Point, Visio, SharePoint, Teams)
Exceptional relationship building skills to work with internal and external stakeholders and user groups and quickly understand their needs and the scientific, clinical, and operational problems that need solving.
Ability to influence and persuade other stakeholders by applying knowledge and expertise to drive desired departmental while preserving relationships
Excellent attention to detail, organisational, communication and stakeholder management skills
Highly proactive in identifying risks, raising issues, and identifying solutions within the project and predict where opportunities for improving processes may arise in the future
Delivery-focused mindset, capable of scaling at pace, taking operational and practical ownership of projects
Strong track record in a relevant scientific discipline
Education
BS/BA in life sciences; advanced degrees preferred