Director, Project Management – IEP & HEOR

Role Summary

The Director, Project Management – Integrated Evidence Planning (IEP) & Health Economics and Outcomes Research (HEOR) leads cross-functional planning, execution, and governance of integrated evidence generation activities. This role ensures seamless coordination across the company to deliver high-impact evidence that drives clinical adoption, patient access, and differentiation of the pipeline assets. It requires strategic thinking, operational excellence, and expertise in medical evidence planning—including real-world evidence (RWE), HEOR, and data generation initiatives aligned with launch strategies and lifecycle management.

Responsibilities

• Strategic Program Leadership
  • Lead program management for Integrated Evidence Plans (IEP), ensuring alignment across clinical, medical, and market access functions.
  • Oversee project planning for HEOR and RWE initiatives to support product value proposition, access, and payer engagement strategies.
  • Serve as program lead for evidence generation planning in preparation for key milestones such as NDA submissions, HTA reviews, and global product launches.
• Cross-Functional Coordination
  • Facilitate collaboration between Global Medical Affairs, Clinical Development, Biostatistics, Market Access, Regulatory, and Commercial on data generation priorities and execution.
  • Drive governance of the Integrated Evidence Working Group (IEWG) and ensure transparent communication of goals, timelines, and deliverables.
  • Maintain regular check-ins with Medical Affairs and key groups to determine IEPs need to be updated.
• Operational Execution & Oversight
  • Build and manage cross-functional project plans, dashboards, and timelines to monitor progress and mitigate risks across IEP and HEOR initiatives.
  • Support internal review, approval, and documentation of evidence generation activities in alignment with compliance and SOPs.
  • Maintain calendar of IEP activities.
• Process Excellence & Infrastructure
  • Champion process improvement and operational efficiency across IEP and HEOR planning cycles.
  • Implement tools (e.g., Veeva Medical, Smartsheet) and frameworks to optimize planning, documentation, and tracking of evidence generation deliverables.
  • Help to facilitate broad IEP development and implementation.
• Stakeholder Engagement & Communication
  • Coordinate with external stakeholders including research collaborators, data vendors, and HEOR partners to ensure timely and high-quality execution.
  • Drive preparation and delivery of cross-functional updates, dashboards, and communication materials for senior leadership and governance committees.
  • Work across Medical Affairs and RWE/HEOR leadership to ensure engagement and alignment of all evidence generation activities.
• Team Leadership & Vendor Management
  • Provide guidance and oversight to junior project management staff and contractors.
  • Oversee vendor performance and budget adherence for outsourced HEOR, RWE, or medical data generation services.

Qualifications

• Required: Bachelor’s degree; advanced degree (MS, MPH, PharmD, PhD, MBA) or PMP certification strongly preferred.
• Required: 15+ years of experience in biotechnology or pharmaceutical industry (with BS), 13+ years (with MS) or 11+ years (with PharmD/PhD), including 8+ years of direct project/program management in Medical Affairs or Evidence Generation.
• Required: Deep knowledge of HEOR, RWE, and medical affairs data generation practices and compliance frameworks.
• Required: Experience supporting integrated evidence plans, HTA submissions, and cross-functional alignment across medical, access, and commercial.
• Required: Proven ability to lead matrix teams and influence across levels and disciplines.
• Required: Strong project governance skills and fluency in PM tools and platforms (e.g., Veeva, Smartsheet, MS Project).
• Required: Experience in oncology or precision medicine is highly preferred.
• Required: Excellent communication, organization, and presentation skills.
• Preferred: Previous experience managing launch-focused IEPs in oncology.
• Preferred: Familiarity with global payer evidence needs and HEOR methodologies.
• Preferred: Demonstrated success implementing evidence governance models and working groups.

Education

• Bachelor’s degree required; advanced degree (MS, MPH, PharmD, PhD, MBA) or PMP certification strongly preferred.