Associate Director, Real World Evidence Strategy (Integrated Evidence Planning) (FSP Sponsor Dedicated)

IQVIA

Durham (NC)

Sur place

USD 120 000 - 180 000

Plein temps

Il y a 5 jours
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Résumé du poste

IQVIA is seeking a senior-level Integrated Evidence Planning Coordinator to support the development, maintenance, and monitoring of asset-level Integrated Evidence Plans (IEPs) under the Chief Medical Office. You will lead coordination with Medical Affairs, Epidemiology, Regulatory, and other partners to translate evidence strategy into structured plans and deliverables.

You will maintain IEPs, track milestones, and support governance reviews, ensuring alignment with asset priorities and

Qualifications

  • PhD or Master's in Epidemiology preferred; other degrees may be considered with relevant experience.
  • Experience supporting Integrated Evidence Planning.
  • Experience coordinating multi-stakeholder planning and translating strategy into clear plans, actions, timelines, and tracking mechanisms.
  • Strong knowledge of the drug-development process and medical evidence generation across asset lifecycles; oncology experience preferred.
  • Ability to facilitate cross-functional discussions, document decisions, and escalate when needed.

Responsabilités

  • Coordinate development of Integrated Evidence Plans (IEPs) based on evidence strategy and priorities established by the MED Lead and asset leadership.
  • Facilitate cross-functional working sessions to gather input from Medical Affairs, Epidemiology/RWE, Statistics/Programming, Regulatory, Safety, Operations, Quality, Global Access & Value, International, and other partner functions.
  • Translate approved evidence strategy into a structured IEP with documented gaps, activities, owners, timelines, and deliverables.
  • Apply planning frameworks, templates, and standards for consistency and quality across IEPs.
  • Escalate unresolved strategic questions, prioritization decisions, and resource constraints to the appropriate forum.
  • Maintain current versions of IEPs and coordinate reviews/refreshes in response to strategy changes.
  • Support evaluation of operational feasibility of proposed evidence-generation activities.
  • Identify opportunities to apply evidence-generation approaches and bring recommendations to subject-matter experts.
  • Coordinate ongoing monitoring of IEP activities, milestones, dependencies, risks, and changes.
  • Prepare progress updates and decision-support materials for leaders and stakeholders.
  • Follow up to reflect actions and deliverables in tracking tools.
  • Support early research concept discussions by documenting requirements and connecting teams with experts.
  • Track execution risks and mitigation actions.
  • Provide operational input into study-design discussions while deferring final decisions to leaders.
  • Coordinate review of regulatory and study-level documents as requested.
  • Participate in therapy-area or enterprise evidence-generation initiatives as the operational lead for assets.

Connaissances

Stakeholder coordination
Project coordination
Cross-functional collaboration
Documentation
Communication

Formation

PhD in Epidemiology
MD/PharmD/Bachelor's with experience

Description du poste

Job Summary

This role within the Chief Medical Office organization will support the operational development, maintenance, and monitoring of asset-level Integrated Evidence Plans (IEPs). Working under the strategic direction of the Medical Evidence Development Therapeutic Area Lead and other designated strategy owners, this role will lead the coordination of evidence plan development, facilitate cross-functional input, track execution, and support timely updates as evidence needs and asset priorities evolve.

Responsibilities
Integrated Evidence Planning Coordinatio n

Coordinate the development of Integrated Evidence Plans (IEPs) based on evidence strategy and priorities established by the Medical Evidence Development Therapeutic Area Lead, asset leadership, and relevant governance teams.

Facilitate/coordinate cross-functional working sessions to gather, document, and reconcile input from Medical Affairs, Epidemiology/RWE, Statistics/Programming, Regulatory, Safety, Operations, Quality, Global Access & Value, International, and other partner functions.

Translate approved evidence strategy into a structured IEP that clearly documents evidence gaps, planned activities, dependencies, owners, timelines, and expected deliverables.

Apply established planning frameworks, templates, and standards to support consistency and quality across assigned asset IEPs.

Escalate unresolved strategic questions, prioritization decisions, resource constraints, and material cross-functional misalignment to the appropriate strategy owner or governance forum.

Maintain current versions of assigned IEPs and coordinate periodic reviews and refreshes in response to approved strategy changes, emerging evidence, study results, or changes in asset plans.

Support evaluation of whether proposed evidence-generation activities are operationally feasible and sufficiently defined for implementation.

Identify opportunities to apply established or emerging evidence-generation approaches and bring recommendations to appropriate subject-matter experts and decision owners.

IEP Maintenance, Monitoring & Execution Support

Coordinate ongoing monitoring of IEP activities for assigned assets, including milestones, dependencies, risks, decisions, and changes to planned evidence-generation activities.

Partner with the MED Program Management team and study teams to maintain trackers, dashboards, meeting materials, and status reports supporting oversight of the medical research agenda.

Prepare consolidated progress updates and decision-support materials for the Therapeutic Area Lead, asset teams, Medical Affairs leadership, and other designated stakeholders.

Follow up with activity owners to confirm that approved actions, plan updates, and agreed deliverables are reflected in the IEP and supporting tracking tools.

Support early research concept discussions by documenting requirements, coordinating input, and connecting teams with relevant MED and functional subject-matter experts.

Track execution risks and limitations, support development of mitigation actions, and escal

Provide operational input into selected study-design and planning discussions, while deferring final scientific, strategic, regulatory, and prioritization decisions to accountable functional leaders.

Coordinate review of selected regulatory and study-level documents by the appropriate MED asset and functional reviewers, as requested.

Participate in therapeutic-area or enterprise evidence-generation initiatives as the operational representative for assigned assets.

Qualifications

PhD or Master's degree in Epidemiology preferred . MD, PharmD, Bachelor's degree may be considered with significant applicable experience.

Experience supporting Integrated Evidence Planning required . Experience supporting medical affairs research, real world evidence, outcomes research, or clinical development is an added bonus.

Experience coordinating multi-stakeholder planning activities and translating strategic direction into clear plans, actions, timelines, and tracking mechanisms.

Strong working knowledge of the drug-development process and the role of medical evidence generation across the asset lifecycle; oncology experience is preferred where relevant to the assigned portfolio.

Strong understanding of observational research, real-world evidence, and low-interventional study approaches, with the ability to engage appropriate scientific and methodological experts.

Demonstrated ability to facilitate cross-functional discussions, synthesize diverse inputs, document decisions, and escal

Strong organizational, project coordination, and communication skills, with attention to version control, dependencies, risks, and follow-through.

Experience supporting regulatory-grade evidence projects or regulatory interactions is desirable; accountability for regulatory strategy or correspondence is not required.

Ability to work effectively in

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