Associate Director, Medical Affairs

Mavericks Wanted 

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on 
  
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.  
  
Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work. 

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

As a global company, our comprehensive benefits may vary based on location.  We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

For USA based roles:

Financial & Rewards  

• Market-leading compensation   

• 401(k) with employer match   

• Employee Stock Purchase Program (ESPP)  

• Pre-tax commuter benefits (transit and parking)  

• Referral bonus for hired candidates  

• Subsidized lunch and parking on in-office days  

Health & Well-Being  

• 100% employer-paid medical, dental, and vision premiums for you and your dependents  

• Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)  

• Fertility & family-forming benefits  

•  Expanded mental health support (therapy and coaching resources)  

• Hybrid work model with flexibility  

• Flexible, “take-what-you-need” paid time off and company-paid holidays  

• Comprehensive paid medical and parental leave to care for yourself and your family  

Skill Development & Career Paths: 

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility 

• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching 

• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities