Senior Director, Medical Information
New
D
Dyne TherapeuticsBiotechnology, Rare Diseases
This position is based in Waltham, MA, with the option to work remotely.Full-TimeDirector
Salary230,000 - 295,000 USD per year
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Job Details
- Experience
- 15+ years
- Required Skills
- Process improvement
Requirements
- Doctorate degree (MD, PhD, PharmD)
- 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 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
Responsibilities
- 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
- Develop high-quality medical information response documents (standard response letters, FAQs, backgrounders) and maintain medical information content
- 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
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