Medical Evidence Development Asset Lead (FSP, Sponsor Dedicated) at IQVIA in Durham, North Carolina, United States of America

Job description

• 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.

Responsibilities

• 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
• 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

Requirements

• 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
• 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 demands of the situation and audience. Communicates clearly and effectively uses well-structured, logical arguments and avoids unnecessary technical or complex language.
• Builds supportive relationships within a team, based on trust and respect. Requires listening to others, adapts to other people's different work styles and focuses on shared goals. Willing to challenge others and accepts challenges as a way of getting the best results for the team.
• Develops strong, lasting relationships with clients. Possesses desire to understand and satisfy customers’ needs and exceed expectations whenever possible. Concern with clients inside or outside the organization; internal customers may be other departments or individuals from the same organization.
• Makes clear, appropriate decisions. Performs with incomplete or ambiguous information, and while under time pressure. Resilience in making unpopular decisions when necessary, and taking responsibility for outcomes and impacts of those decisions.
• Responds well to change. Positive attitude toward change and a readiness to adapt when presented with new information, new situations or shifting priorities.
• Balances the need to shape outcomes in short term while maintaining successful long-term relationships. Knows how to motivate and inspire to achieve a common goal, and demonstrates key strategic negotiation tactics. Uses personal and professional contacts to influence people across teams or organizations.
• Enables others to perform. Sets a clear direction and delegates fairly and appropriately allowing direct reports the means to achieve their goals. Looks for opportunities to develop individuals by encouraging them to take on greater responsibility and make decisions for themselves.
• Establishes and prioritizes tasks and objectives in order to manage time and resources appropriately. Sets deadlines based on the time required, and on how each part of the plan affects others. Prepares backup plans in case the situation changes.
• Creates a clear view of the future of the business. Considers the long-term goals of the organization and defines the strategy to achieve this. Takes into account the current environment in which the business operates and anticipates future changes or challenges for the organization.
• Shows comfort and aptitude using technology in order to reach goals more efficiently, and to a higher standard of quality. Welcomes advancements in technology and is willing to understand and implement them. Uses technology appropriately, and helps others to appreciate and understand the benefits of using technology.

Skills

Preferred

• Ability to speak clearly and fluently
• Ability to write clearly and succinctly
• Makes clear, appropriate decisions
• Responds well to change
• Enables others to perform

Benefits

• The potential base pay range for this role, when annualized, is $140,200.00 - $390,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.