Medical Affairs Director - Rare Disease

Company Overview

A global, biopharmaceutical company is seeking a Medical Affairs Director to support its growing Japan organization. The company is focused on developing innovative treatments for patients living with rare diseases and improving outcomes for patients and their families.

Job Summary

The Medical Affairs Director will support the development and execution of the Japan Medical Affairs strategy and related medical activities under the direction of the Japan Medical Affairs leadership. The role will collaborate closely with global Medical Affairs and cross-functional teams, including Regulatory, Clinical Development, Market Access, and Marketing.

Key areas of responsibility include advisory boards, publication planning, congress activities, medical education, scientific communications, evidence generation, and engagement with healthcare professionals and external experts.

Responsibilities

• Contribute to the development of the Japan Medical Affairs plan in alignment with global and local strategies.
  
• Execute medical tactics and operational activities outlined in the Medical Affairs plan.
  
• Plan and execute advisory boards in collaboration with Japan and global Medical Affairs teams.
  
• Build and maintain relationships with Key External Experts, Principal Investigators, and relevant medical societies in Japan.
  
• Lead Japan publication activities, including abstracts, manuscripts, and congress presentations.
  
• Coordinate scientific activities at congresses and ensure alignment with publication and communication strategies.
  
• Develop and deliver scientific training and educational content for internal teams and field-based colleagues.
  
• Provide ongoing scientific and medical support to field teams and cross-functional partners.
  
• Review promotional and non-promotional materials for scientific accuracy and compliance.
  
• Support collaborative research and investigator-initiated studies, including protocol review and scientific oversight.
  
• Interpret clinical and real-world data to generate medical insights and inform evidence-generation priorities.
  
• Collaborate with Regulatory, Clinical Development, Market Access, Marketing, and global Medical Affairs teams.
  
• Ensure compliance with Japanese regulations, company policies, and relevant industry standards.
  
• Provide medical input for external-facing materials and activities while maintaining appropriate separation from promotional decision-making.
  
• Strengthen scientific engagement and relationships with external experts.
  
• Contribute to the development of scientific communication platforms and ensure consistency of messaging.
  
• Support activities related to access information and disease awareness initiatives.
  
• Support regulatory submission activities, including interactions with regulatory authorities and preparation of related documentation.
  
• Track progress against Medical Affairs plan deliverables and report relevant metrics.
  
• Build relationships with relevant patient advocacy organizations to support disease awareness.
  
• Take on additional responsibilities as needed to support team and organizational objectives.
  

Requirements

Mandatory: Proven publication track record, including experience as a lead author for abstracts, manuscripts, and congress presentations.

Advanced degree required; PhD, MPH, or MD preferred.

3–5+ years of relevant pharmaceutical and/or biotechnology industry experience.

Previous Medical Affairs experience strongly preferred.

Experience in rare diseases is a plus.

Product launch experience is a plus.

Experience working in a fast-paced environment is a plus.

Track record of Real-World Evidence generation and dissemination.

Excellent scientific communication and presentation skills, with confidence facilitating discussions with internal and external stakeholders.

Familiarity with Japanese regulatory, compliance, and ethical standards relevant to Medical Affairs.

Excellent English communication and presentation skills.

Proven ability to collaborate across functions and international teams.

Proactive, detail-oriented, and operationally strong.

Proficiency in Microsoft Office, including PowerPoint, Word, and Excel.

Willingness to travel as required (up to approximately 20%).