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Position Overview:

With the tremendous promise that Prime editing brings to the treatment of a broad spectrum of serious diseases, also comes the significant challenge of communicating about this new technology to external audiences who may not have specific scientific backgrounds: in particular, patient groups and payors. We are seeking a unique individual with the ability to analyze and quantify the prospective benefit of a genetic technology for patients and the healthcare system, to effectively communicate about this potential to both patient groups and payors, and reciprocally, to provide the voice of these external collaborators back to Prime Medicine.

This role will be instrumental in fostering strong relationships with patient communities, driving patient-centric initiatives, and utilizing real world data to enhance our understanding of treatment outcomes and patient needs. The ideal candidate will bring a deep understanding of biotech, patient engagement, and RWE methodologies to drive our mission forward.

The individual hired into this role will be charged with establishing this new function at Prime Medicine. This role reports to the head of Clinical, and will be a critical part of a larger medical affairs function that is being built.

Responsibilities:

Patient Advocacy:

• Develop and execute a comprehensive patient advocacy strategy aligned with the company's mission and goals.
• Cultivate and maintain strong relationships with patient advocacy groups, ensuring effective collaboration and understanding of patient perspectives.
• Champion the patient voice internally, influencing decision-making across departments to ensure patient-centricity in all aspects of our work.
  • Organize patient or care-giver presentations to the Prime team.
• Lead the planning and organization of patient advisory boards, ensuring valuable insights are incorporated into protocol development, and for the purposes of documenting such feedback per regulatory obligations.

Real World Evidence Generation:

• Design and oversee the implementation of RWE studies to gather insights on treatment effectiveness, safety, and patient outcomes. These include:
  • Partnering with existing disease registries and academic groups collecting data on disease outcomes
  • Developing and implementing Prime-sponsored observational trials.
• Ensuring that patient reported outcomes, quality of life instruments and healthcare utilization endpoints are all appropriately addressed within all Prime-sponsored protocols (interventional, observational and follow-up).
• Collaborate with cross-functional teams including Clinical Development and Regulatory Affairs to ensure RWE studies align with regulatory requirements and strategic objectives.
• Collaborate with external partners including clinical research organizations, academic institutions, and other stakeholders to access relevant data sources and establish collaborative RWE research initiatives, and in the management of Prime-sponsored observational trials.
• Analyze and interpret RWE findings to generate actionable insights that inform communication to payors
• Communicate RWE findings to external audiences including in academic publications and to payors and HTA bodies.

Leadership and Team Development:

• Be ready to build a team of professionals dedicated to patient advocacy and RWE efforts, fostering a collaborative and innovative work environment.
• Collaborate with senior leadership to align patient advocacy and RWE initiatives with the overall company strategy.

Qualifications:

• Advanced degree in healthcare or economics-related field (MD, PhD, MPH, Masters in Economics or Statistics).
• Minimum of 6 years of experience in biotech or pharmaceutical industry (or an equivalent academic, consulting or governmental position), with a focus on patient advocacy and real world evidence generation for at least 3 years.
• Strong knowledge of pharmaceutical development, scientific project management, real world data collection, RWE generation, and regulatory requirements. Experience in health economics and outcomes research strongly preferred.
• Proven track record of successfully engaging with patient advocacy groups and incorporating patient perspectives into clinical protocols, regulatory communications and strategic decisions.
• Strong expertise in real world evidence methodologies, including study design, data collection, analysis, and interpretation.
  • Relevant familiarity with statistical methodologies
• General understanding of Good Clinical Practice
• Experience contributing to authorship of clinical protocols, especially as pertains to the collection and analysis of patient reported outcomes, quality of life instruments and healthcare utilization endpoints.
• Ability to manage clinical research organizations and academic partnerships in the execution of observational trials.
• Exceptional communication and collaboration abilities, with the aptitude to work effectively across multidisciplinary teams and external stakeholders.
• In-depth understanding of regulatory requirements related to real world evidence and patient engagement.
• Strategic mindset with the ability to translate insights from patient advocacy and RWE into actionable recommendations for the organization.
• Ability to function independently, with a strong direct “hands on” approach, required in a nascent biotech.
• Ability to travel as necessary to engage with patient advocacy groups, payors, HTA bodies and/ or attend conferences and presentations.