Senior Medical Director

Role Summary

The Senior Director, Global Medical Affairs leads medical strategy and execution for MIPLYFFA (NPC) and OLPRUVA (UCDs), guiding medical communications, evidence generation, payer engagement, and cross-functional collaboration. The role is based on-site in Boston, MA.

Responsibilities

• Develop, refine and lead the medical affairs strategy including data dissemination plan, scientific communications, congress planning, advisory board planning, medical education, publications planning, and payer engagement
• Serve as the cross-functional medical affairs lead to support marketing, sales, advocacy, market access, and other collaborative planning and tactical execution across the company
• Maintain high level of scientific and medical expertise in NPC and UCD and serve as key medical resource in the diagnosis, treatment and management of targeted disease areas and associated products
• Collaborate closely with Field Medical Leadership to develop and support the successful execution of the field medical engagement strategy and ensure alignment with the product strategy
• Lead/support the development of content and resources to support external engagement activities by the field medical affairs team and support/oversee the training of the team
• Serve as the MIPLYFFA and OLPRUVA medical reviewer for abstracts, publications, disease-related and product related promotional materials and non-promotional scientific materials, including reimbursement dossiers and payer materials
• Lead and support clinical studies and evidence generation activities including Phase IV clinical studies, registries, and expanded access programs
• Develop and communicate medical information and scientific communication content and key findings externally and within the company
• Provide medical expertise to the commercial organization to compliantly assist in the development and execution of commercial activities, including training
• Ensure medical affairs compliance with all corporate, legal and regulatory requirements
• Collaborate or serve on cross-functional global teams as directed by the SVP of Medical Affairs and Advocacy
• Help attract talent to the organization

Qualifications

• Advanced degree in scientific discipline required (e.g., PhD, PharmD, MD)
• Strong strategic and business acumen as evidenced by at least 8 years in Medical Affairs, with at least 5 years building and leading medical affairs plans and supporting drug launches
• Developing and leading medical communications plans and deliverables
• Expertise in rare diseases and rare disease drug development
• Medical affairs planning and execution
• Building and leading medical launch plans
• Cross-functional engagement, support and collaboration
• Evidence Generation
• KOL Engagement
• Stakeholder management

Skills

• Medical leadership and strategic thinking
• Scientific communication and publications planning
• Evidence generation and clinical study oversight
• Cross-functional collaboration and program management
• Regulatory and compliance awareness in medical affairs