Posted by
Danielle Shemberev
Recruitment Marketing Manager at Amgen
Last Active: NA as recruiter has posted this job through third party tool.
Posted in
Consulting
Job Code
1705101

About the Role:
- Increasing demand for observational research and real-world evidence (RWE) from regulatory and reimbursement authorities makes observational research a critical component of drug development and commercialization.
- The CfOR Strategic Planning & Operations Manager drives operational excellence, strategic execution, workforce planning, study operations, analytics, and digital transformation across the organization.
- This role requires expertise in business operations, study management, data analytics, dashboarding, forecasting, process optimization, and digital enablement.
- The ideal candidate is analytical, execution-oriented, and capable of translating complex operational data into actionable leadership insights using tools such as Power BI.
Strategic Planning & Business Operations:
- Partner closely with CfOR leadership to support strategic planning, operational execution, workforce planning, and organizational initiatives.
- Drive cross-functional operational programs and strategic initiatives across global teams, ensuring alignment with organizational goals and priorities.
- Support leadership decision-making through business analysis, operational insights, scenario planning, and executive-ready presentations.
- Manage and track organizational priorities, risks, dependencies, timelines, and action plans across multiple workstreams.
- Support headcount management, staffing analysis, requisition tracking, organizational planning, resource forecasting, and capacity planning.
- Support operational budgeting, financial tracking, forecasting, and resource planning activities across organizational initiatives and study operations.
- Analyze resource utilization, portfolio demand, operational capacity, and forecasting trends to support leadership planning and prioritization decisions.
- Lead operational transformation initiatives and strategic special projects.
- Support organizational governance activities including leadership reviews, operational planning cadences, hiring alignment, and cross-functional coordination.
- Drive operational readiness initiatives across teams by improving visibility into resource capacity, prioritization, and execution tracking.
- Partner with functional leaders to streamline onboarding, collaboration models, knowledge management, and operational communication frameworks.
Data Analytics, Reporting & Visualization:
- Develop and maintain executive dashboards, operational metrics, KPIs, and reporting frameworks using Power BI and other visualization tools.
- Translate operational, organizational, and portfolio data into actionable insights for senior leadership.
- Analyze trends across resource allocation, study delivery, operational efficiency, financials, forecasting, and portfolio performance to support strategic decisions.
- Build scalable reporting solutions that improve visibility, transparency, and operational governance across CfOR.
- Partner with stakeholders to define reporting standards, business requirements, and performance measurement frameworks.
- Develop integrated reporting solutions, forecasting models, and self-service dashboards across multiple operational data sources.
- Drive data quality, reporting consistency, process standardization, and governance across operational systems.
Study, Project & Program Management:
- Lead operational planning, coordination, and execution of observational research studies and cross-functional operational initiatives.
- Partner with study teams, functional stakeholders, and vendors to support study timelines, deliverables, operational readiness, and execution tracking.
- Support end-to-end study operations including planning, governance, resource coordination, risk tracking, issue resolution, and stakeholder communication.
- Develop and maintain project plans, roadmaps, RAID logs, governance trackers, and operational documentation.
- Facilitate cross-functional meetings, manage dependencies, and ensure timely completion of operational and study-related milestones.
- Monitor portfolio progress, operational risks, execution metrics, and forecasting trends to support proactive decision-making.
- Communicate project and study status, risks, escalations, and key updates effectively to stakeholders and leadership.
- Support vendor coordination, budget tracking, financial monitoring, forecasting activities, and resource management.
- Operate effectively in fast-paced, matrixed environments with evolving priorities and competing business needs.
Digital Transformation & Operational Excellence:
- Lead adoption and optimization of digital collaboration and workflow tools including Microsoft Teams, SharePoint, Miro, and Power Platform solutions.
- Support SharePoint governance, content organization, operational documentation, and knowledge management initiatives across teams.
- Evaluate and implement modern workflow management and collaboration tools that improve operational scalability and team effectiveness.
- Identify opportunities to improve operational processes through automation, standardization, and digital enablement.
- Leverage AI and productivity tools such as Microsoft Copilot, ChatGPT, and AI agents to streamline workflows, documentation, communications, reporting, and meeting management.
- Support experimentation and implementation of emerging technologies that enhance organizational efficiency and stakeholder engagement.
- Drive continuous improvement initiatives focused on scalability, operational maturity, and user experience.
Stakeholder Management & Communication:
- Build strong collaborative relationships across CfOR, study teams, functional partners, and enterprise stakeholders.
- Influence stakeholders across varying levels of the organization through structured problem-solving, operational leadership, and data-driven recommendations.
- Prepare executive communications, dashboards, presentations, operational summaries, leadership business reviews, and forecasting updates.
- Facilitate alignment across geographically distributed teams through structured communication, governance processes, and operational planning.
- Act as a trusted strategic operations partner capable of balancing organizational priorities with tactical execution.
Preferred Qualifications:
- 8-10+ years of experience in strategic operations, program management, business operations, analytics, or related roles within pharma, biotech, healthcare, consulting, or regulated industries.
- Strong expertise in Power BI, dashboard development, data visualization, operational analytics, and reporting automation.
- Advanced proficiency in Microsoft Excel, PowerPoint, Power BI, Microsoft O365, SharePoint, and modern workflow/project management platforms.
- Experience supporting operational management of observational research studies or cross-functional healthcare/pharma initiatives preferred.
- Experience building executive-level dashboards and presenting operational insights to senior leadership teams.
- Strong analytical and problem-solving skills with the ability to synthesize large datasets into actionable recommendations.
- Proven ability to manage complex cross-functional projects in fast-paced, matrixed environments.
- Experience with Agile methodologies including SAFe, Scrum, and Kanban.
- Demonstrated ability to improve operational efficiency through automation, process optimization, and digital transformation initiatives.
- Familiarity with Power Platform tools (Power Automate, Power Apps) and workflow automation solutions preferred.
- Working knowledge of AI productivity tools such as Microsoft Copilot, ChatGPT, AI agents, and other emerging digital solutions.
- Strong communication and stakeholder management skills with the ability to influence across organizational levels.
- Experience supporting workforce planning, hiring coordination, resource management, budgeting, forecasting, and strategic planning activities.
- Experience with operational budgeting, portfolio forecasting, capacity planning, and business planning support preferred.
- Experience building scalable operational processes, governance frameworks, and executive reporting models in matrixed organizations preferred.
- Understanding of pharmaceutical development, real-world evidence, clinical operations, or healthcare business environments preferred.
- Knowledge of GxP, regulatory, and compliance environments is a plus.
Key Success Attributes:
- Strategic thinker with strong operational execution capabilities.
- Highly data-driven with strong business acumen.
- Comfortable balancing strategy, analytics, operations, and execution.
- Strong ownership mindset with ability to independently lead initiatives.
- Collaborative and relationship-oriented with excellent communication skills.
- Passion for innovation, continuous improvement, and leveraging technology to drive efficiency.
- Adaptable, agile, and capable of thriving in rapidly evolving environments.
Preferred Qualifications:
- Minimum of 10 years of project management experience, including 5+ years in pharma/biotech within regulated, cross-functional environments.
- Proven ability to lead complex projects end-to-end in fast-paced, matrixed settings; experienced in budgeting, resource planning, vendor management, and risk mitigation.
- Skilled at managing ambiguity and shifting priorities through structured thinking, stakeholder alignment, and agile decision-making.
- Highly motivated and proactive professional who thrives with minimal supervision, balancing multiple initiatives while ensuring compliance with regulatory standards and organizational processes.
- Expertise in evaluating current-state operations and designing scalable, creative solutions improving efficiency, quality, stakeholder satisfaction.
- Superior communication and presentation skills with ability to translate complex data into dashboards for diverse stakeholders, including Senior Leadership Team
- Comprehensive understanding of Good Clinical Practices (GCP), FDA regulations, and applicable regulatory/compliance frameworks critical to clinical and commercial operations
- Familiarity with drug commercialization & business practices
- High proficiency in Smartsheet, Microsoft O365, and Miro, with a focus on leveraging tools for planning, tracking, and visual collaboration
- Passionate about continuous improvement and applying emerging technologies to increase productivity, automate repetitive tasks, and enhance stakeholder engagement
- Working knowledge of AI tools such as Microsoft Copilot, ChatGPT, and AI Agents, with practical experience integrating these into project workflows.
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Posted by
Danielle Shemberev
Recruitment Marketing Manager at Amgen
Last Active: NA as recruiter has posted this job through third party tool.
Posted in
Consulting
Job Code
1705101