Senior Director, Medical Information

Role: Senior Director, Medical Information

Responsibilities:
- Establish and lead the medical information function (strategy, processes, execution).
- Build scalable medical information infrastructure (inquiry intake, documentation, response workflows).
- Oversee implementation and training for the medical inquiry intake portal and call center vendors; manage vendor relationships.
- Develop medical information response documents (standard response letters, FAQs, backgrounders) and maintain content aligned with product labeling, clinical data, and evolving evidence.
- Lead and oversee Medical, Legal, and Regulatory (MLR) review.
- Ensure responses are scientifically accurate, balanced, current, and compliant.
- Coordinate appropriate escalation for safety, quality, and off-label inquiries.
- Analyze inquiry trends to identify knowledge gaps, unmet needs, and inform medical strategy.
- Monitor metrics and quality indicators to ensure continuous improvement and compliance.

Qualifications/Skills:
- Doctorate degree (MD, PhD, PharmD) with 15+ years’ experience in medical information or medical affairs in rare diseases, neuromuscular diseases, or related field.
- Strongly preferred: experience establishing or leading a medical information function.
- Strong understanding of regulatory, compliance, and pharmacovigilance requirements.
- Excellent scientific writing and verbal communication skills.
- Strong organizational and process-building skills; high attention to detail and scientific integrity.
- Ability to work effectively in a matrixed, fast-paced biotech environment.
- Strong judgment handling complex/sensitive inquiries.

Location:
- Waltham, MA; option to work remotely.

MA Pay Range:
- $230,000 - $295,000 USD.