Role Summary:

The Senior Director, Medical Information is responsible for establishing and leading the medical information function to ensure timely, accurate, balanced, and compliant scientific responses to unsolicited inquiries from healthcare professionals. This role plays a critical part in supporting the safe and appropriate use of the company’s products by delivering high-quality medical information and enabling scientific exchange. The person in this role has strong scientific expertise, experience in regulated environments, and the ability to build scalable medical information processes in a biotech setting. 

This position is based in Waltham, MA, with the option to work remotely. 
 
Primary Responsibilities Include: 

• Establish and lead the medical information function, including strategy, processes, and execution 
• Establish scalable medical information infrastructure, including inquiry intake, documentation, and response workflows 
• Oversee the implementation and training of the medical inquiry intake portal and call center vendors and manage relationships going forward 
• Develop high-quality medical information response documents (standard response letters, FAQs, backgrounders) and maintain medical information content aligned with product labeling, clinical data, and evolving scientific evidence 
• Lead and oversee Medical, Legal, and Regulatory (MLR) review  
• Ensure responses are scientifically accurate, balanced, up-to-date, and compliant with regulation 
• Ensure appropriate escalation and coordination of safety, quality, and off-label inquiries 
• Analyze inquiry trends to identify knowledge gaps, unmet medical needs, and opportunities to inform medical strategy 
• Monitor metrics and quality indicators to ensure continuous improvement and compliance 

Education and Skills Requirements: 

• Doctorate degree (MD, PhD, PharmD) with 15+ years of experience in medical information or medical affairs in rare diseases, neuromuscular diseases, or a related field 
• Experience establishing or leading a medical information function is strongly preferred 
• Strong understanding of regulatory, compliance, and pharmacovigilance requirements 
• Excellent scientific writing and verbal communication skills 
• Strong organizational and process-building capabilities 
• High attention to detail and commitment to compliance and scientific integrity 
• Ability to work effectively in a matrixed, fast-paced biotech environment 
• Strong judgment in handling complex or sensitive inquiries