Associate Director, Medical Affairs

What You'll Do  

The Associate Director, Medical Affairs, will play a key cross-functional role supporting the development, coordination, and execution of strategic medical initiatives across medical affairs for ML Bio Solutions (ML Bio), a BridgeBio company. ML Bio is developing BBP-418, potentially the first oral treatment for patients with Limb Girdle Muscular Dystrophy type 2I/R9 (FKRP-related) (LGMD2I/R9).  

This individual will serve as a core liaison between external vendors/stakeholders, the medical, legal and regulatory review team, driving medical execution to support the organization’s strategic goals.  

Responsibilities  

• Be the medical reviewer on the medical, legal and regulatory review committee 
• Develop response letters for non-standard Medical Information requests 
• Review tactics for messaging/lexicon alignment, scientific accuracy, appropriateness for audience, quality, and provide direction to medical communication agencies during development, and reviews 
• Facilitate the communication of clinical data and scientific information to both internal and external stakeholders 
• Collaboratively develop and help execute medical plans in alignment with the company's overall strategy 
• Ensure that all medical activities are compliant 
• Represent the company at scientific conferences, advocacy meetings, external executive joint meetings, and other events 

Where You'll Work  

This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.  

Who You Are  

• PharmD, Ph.D., MD required 
• 5+ years of experience in the Medical Affairs, with preference for experience in medical (MLR) review and/or Medical Information  
• 3+ years of experience in Medical Affairs as a content reviewer (MLR)Knowledge of pharmaceutical regulations, regulatory compliance and quality assurance  
• Experience in rare diseases, especially rare neuromuscular diseases preferred  
• Ability to manage simultaneous priorities, changing deadlines, and limited resources required  
• High sense of urgency, attention to detail, and commitment to execution required  
• Strong organizational and prioritization skills  
• Excellent communication and interpersonal skills (including networking) highly organized, and detail-oriented required  
• Travel – 20% time used for travel  

#LI-LN1