Associate Director/Director Pharmaceutical Development

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

Provide strategic pharmaceutical development guidance as the CMC lead to cross functional project teams. 

Develop robust formulations and manufacturing processes to support development and rapid registration of QED products.

Review development and manufacturing programs at CRO’s/external vendors to ensure compliance with agreed proposals, quality standards and timelines. Review external data.

Manage drug forecasts and any associated transactions

Integrate and liaise effectively with CMC team

Provide formulation and Clinical supply expertise/support in the preparation of regulatory submissions (e.g. IB, IND, NDA).

Responsibilities

Ability to work effectively and collaboratively on cross functional project teams, in a fast-paced, dynamic environment under tight timelines.

Develop complex formulation for pediatric indications.

Work effectively with CDMO's.

A team player, functional leader, effective listener, clear communicator and quick learner.

Clear, concise communication style with ability to interact internally and externally.

Willing to “roll up his/her sleeves and do what it takes” to achieve critical program deliverables.

Hands-on experience in clinical trials management/study conduct, formulation development and clinical trial manufacturing.

Knowledge of commercial manufacture

Where You'll Work

Remote with 30% travel expected

Who You Are

PhD or advanced degree in Chemistry or Pharmacy with 7+ years of bio/pharmaceutical industry experience in formulation development and Clinical Supply.

Expertise in formulation in addition to knowledge of PK/PD principles, ADME concepts, and regulatory documentation and authorship.

Knowledge of import/export sensitivities.

Demonstrated ability to manage Clinical Supply, Formulation development and manufacture at CRO’s.

In-depth knowledge and understanding of CMC Regulatory requirements for US and EU are required

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 BridgeBio Full-Time U.S 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