Global Executive Director, Development Real-World Evidence

Overview

The Global Executive Director, Development Real-World Evidence is part of the Clinical Development group and provides strategic oversight and direction for development RWE generation with a focus on supporting clinical trial designs and observational studies to generate innovative and new treatment approaches on a global and/or regional scale for assets in clinical development.

The candidate will be a thought leader with the technical skills to build innovative and scientifically credible evidence for product development and regulatory approval. The successful applicant will lead the evaluation of observational research methods and statistical analysis to define appropriate research data sources, study design, and analytical approaches to be used for regulatory submissions, publications, clinical development plans and study designs as examples.

Responsibilities

• Leads the development and execution of RWE operating plans. 
• Collaborates with multiple stakeholders and partners throughout the organization to design Real-World Evidence (RWE) studies for development stage assets.
• Implements analyses to address product- and disease-area research questions, which will inform business decisions about the research and development of products.
• Collaborates with Medical Affairs to provide patient-centric outcomes and healthcare impact by providing RWE insights into medical decision making
• Drive the preparation and submission of regulatory documents related to RWE
• Collaborate with cross-functional teams, including R&D, clinical development and commercial functions, to ensure alignment and compliance with product development milestones.
• Develop data requirements to meet the RWE objectives
• Represent the company's interests in industry forums, working groups, and regulatory meetings, advocating for regulatory policies and positions that support product development and commercialization objectives.
• Serve as a subject matter expert on global RWE requirements, guidelines, and best practices.
• Prepare and present updates, progress reports, and strategic recommendations to senior and/or executive leadership informing decision-making and driving RWE excellence within the organization.
• Other duties as assigned.

Minimum Job Requirements

Qualifications

• Master’s degree in Public Health, Health Services Research, Economics, Epidemiology, Pharmacy, Health Policy, or a related discipline required. (MD, PhD, PharmD) preferred.
• 10+ years of relevant work experience with a focus on evidence generation, specifically a focus on real-world evidence methodologies / approaches (strongly preferred).
• Proven track record of successful leadership, with demonstrated ability to influence work and align with multiple internal and external stakeholders.
• Strong knowledge of HCP and Payer evidence needs and what is required to support these needs.
• Previous leadership responsibility with demonstrated ability to think and act strategically and proven tactical experience and delivery of results.
• Strategic mindset with the ability to anticipate challenges, identify opportunities, and develop innovative solutions to achieve regulatory objectives.

Competencies

• Strong leadership skills with the ability to effectively lead and motivate a multidisciplinary team, foster collaboration, and drive results in a fast-paced and dynamic environment.
• Ability to conduct and oversee clinical data analysis, epidemiology, and biostatistical elements of RWE and epidemiology.
• Proficiency in preparing and submitting regulatory documents, study plans and publications.
• Strong interpersonal and communication skills with the ability to effectively engage and collaborate with internal stakeholders, cross-functional teams, and external regulatory authorities to achieve regulatory objectives.
• Excellent leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively across functions and regions.
• Extensive knowledge of patterns of medical practice, healthcare delivery and the current and evolving landscape within the US and globally
• To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.

Additional Information

The base salary range for this full-time position is $290,000 - $325,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowance