Director, Evidence Generation

Reporting to the Medical Director, Global Medical Affairs, the Associate Director of Evidence Generation will develop and execute evidence-generation plans, ensuring close alignment with product strategy. In close collaboration with Global Medical Affairs and cross-functional team members, this role will be responsible for driving the execution of a variety of evidence generation activities such as studies on natural history of disease, treatment trends, claims data, qualitative/quantitative research, and registries.

This role is based in the Lexington office and requires employees to be onsite five days a week.

Responsibilities (including, but not limited to):

• Engage with both internal and external stakeholders to perform evidence gap analyses that systematically and proactively identify key unanswered clinical and scientific questions
• Support the planning, design, and execution of evidence generation initiatives including conceptualization, document preparation, protocol reviews, and operational plans
• Manage timelines, deliverables, and budgets for all evidence generation initiatives
• Provide oversight of all evidence generation activity, including CRO-led activities (e.g., site trainings, data collection, data management)
• Translate evidence generation outputs into clear, concise, and targeted messaging and while maintaining medical accuracy and compliance
• Confidently present data to broad range of audiences, both in internal and external settings
• Drive appropriate collaboration with both internal and external stakeholders to assure evidence generation initiatives fit both corporate and product needs
• Closely collaborate with Scientific Communications to assure proper accurate, timely, and impactful dissemination of emerging evidence
• Proactively identify opportunities to improve evidence generation processes and efficiencies, including use of innovative tools and AI

Standout Skills for Success:

• Proactively identify opportunities for evidence generation
• Will clearly communicate complex data sets to various stakeholders
• Will review all datasets and final deliverables, assuring they are thorough, precise, and accurate
• Owns accuracy and timeliness of all deliverables

Qualifications:

• 10+ years of experience in related fields with a concentration in evidence generation
• Scientific degree (PhD, PharmD, MD) or relevant advanced science degree (MS, MPH)
• Direct experience in a pharmaceutical or CRO leading the planning and execution of a disease registry, preferably within rare disease space
• Strong attention to detail
• Ability to collaborate effectively with internal stakeholders and external stakeholders
• Excellent verbal and written communication skills, presentation skills, conflict management, and problem-solving skills are required
• Strong analytical skills and experience with clinical data presentation and interpretation
• Efficient independent worker with ability to focus and drive for results
• Ability to work in a fast paced-environment and to handle multiple tasks
• Strong commitment to compliance and ethical standards
• High proficiency in Microsoft Word, Excel, PowerPoint, CoPilot, and Outlook
• Experience with AI preferred
• Some travel may be required