Medical Evidence Development Asset Lead (FSP, Sponsor Dedicated)

IQVIA; Durham (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

IQVIA in Durham, NC is seeking an Asset Lead for Medical Evidence Development to shape and execute evidence generation plans across assets. You will lead multi-disciplinary teams and coordinate with Medical Affairs, Epidemiology, Statistics, and Regulatory to deliver strategic evidence programs.

The role requires advanced life sciences training, real-world evidence experience, and strong communication. This on-site position offers opportunities across global initiatives and regulatory

Qualifications

• Direct experience leading integrated evidence generation plans (min 1 year, 3+ preferred)
• Advanced science degree in life sciences with RWE experience
• Expert knowledge of drug/oncology development
• Experience with various research methodologies using real-world evidence
• Strong communication and project management skills

Responsibilities

• Oversee asset-level IEP development and evidence generation planning and delivery
• Lead cross-functional teams and coordinate stakeholders across Medical Affairs, Epidemiology/RWE, Statistics/Programming, Regulatory and more
• Advise on study design and planning to ensure feasibility and resources
• Identify risks and mitigate medical affairs research limitations
• Represent MED asset in enterprise evidence generation initiatives

Skills

Evidence generation

Cross-functional leadership

Project management

Regulatory interactions

Real-world evidence

Study design

Communication skills

Education

Advanced science degree (life sciences)

Job description

Job Overview

The Medical Evidence Development Asset Lead FSP within the Chief Medical Office organization will oversee Asset-Level Evidence Generation activities and strategy to ensure that the medical evidence generation needs of an asset are strategically aligned and delivered.

Essential Functions

• 1. Medical Evidence Generation Strategy & Planning Support the development of the integrated evidence generation plan (IEP) Oversee a multi-disciplinary approach to bridge evidence gaps, leveraging capabilities and expertise across epidemiological, RWE, and patient-centered research Lead cross-functional team meetings of colleagues responsible for developing and executing the asset(s) IEP Engage with all relevant stakeholders (e.g., Medical Affairs, Epidemiology/RWE, Statistics/Programming, Regulatory, Safety, Operations, Quality, Global Access & Value, International, etc.) to ensure comprehensive evidence generation planning is conducted and all tactics are implemented in support of medical strategy Guide teams to ensure consistency of approach, appropriate planning and oversight of evidence generation activities for assigned assets Provide expert input into evidence generation tactical plans and implementation Partner with cross-functional teams to ensure adequate CMO resourcing is available for evidence generation activities Conduct review/refresh of asset(s) IEPs Acts as a champion for identifying and implementing novel approaches to real-world evidence generation activities
• 2. Medical Evidence Generation IEP Delivery / Tactical Implementation Oversee the execution of the IEP evidence generation activities of assigned asset(s) Engage MED Program Management team to coordinate ongoing oversight and tracking of evidence generation activities to ensure timely and quality execution of the medical affairs research agenda Partner with MED teams to report on study progress and metrics to R&D, Medical Affairs leadership and other key stakeholders Provide input to partner lines on study design and planning to ensure evidence generation activities are feasible and adequately resourced Lead and/or participate in early research concept discussions with internal and external stakeholders, as the primary representative from the MED organization Proactively and continuously aim to identify and mitigate medical affairs research-related risks and limitations Partner with relevant partner lines to find innovative, efficient and timely approaches to achieve Medical Affairs research agenda deliverables Act as MED asset reviewer for critical regulatory and select study-level documents as needed Represent asset(s) in enterprise and/or therapeutic area evidence generation initiatives

Key Qualifications

• Direct experience leading the development and execution of integrated evidence generation plans ; minimum 1 year required, 3 or more years preferred
• Advanced science degree with significant professional experience in real world evidence and life sciences
• Expert knowledge of drug/oncology development process
• Demonstrated ability to advise on medical evidence generation strategies
• Experience across various research methodologies using real-world evidence, observational and low-interventional study designs
• Highly effective verbal and written communication skills with respect to evidence generation planning and decision making
• Strong organizational and project management skills
• Experience engaging with and supporting regulatory-grade real-world evidence projects including contributing to regulatory interactions/correspondences

Additional Qualifications for Day-to-Day Work

• Ability to speak in detail with CEOs, COOs, and CMOs about brand, launch and commercial strategy services/solutions, specifically in the life sciences industry segment, in a meaningful manner with depth of content knowledge.
• Understanding of client medical, brand and commercial strategies that are specific with regard to international geography.
• Expresses ideas in a clear and concise manner; tailors message to target audience with the gravitas to build relationships across senior stakeholders.
• Maintains understanding of industry, client and competitive trends in the life sciences industry. Applies this knowledge to active client engagements and activities.
• Applies an analytical approach to solving problems and reaching logical conclusions. Gathers information from a variety of sources and quickly gains an understanding of it. Works effectively with complicated, conflicting or ambiguous information, and looks beyond the surface of issues to identify their underlying patterns and causes.
• Ability to speak clearly and fluently. Demonstrates a logical, structured approach, adapts to the needs of the situation and the nature of the audience; confirms the audience has understood the message. Beyond presenting clearly, this competency is also concerned with ensuring strong two-way communication.
• Ability to write clearly and succinctly. Adapts style and content; meets demand