Associate Director, Medical Affairs

BridgeBio Pharma

1d•Remote

About The Position

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.

Requirements

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
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

Nice To Haves

Experience in rare diseases, especially rare neuromuscular diseases preferred

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

Benefits

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
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
Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching