Associate Director – Pharmaceutical Development

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $223k - $239k / year

⏰ Full Time

🟠 Senior

👔 Director

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BridgeBio

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2015

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

BridgeBio is a biotechnology company focused on designing transformative medicines for patients with genetic diseases. It employs a novel approach to drug development by integrating finance with science to deliver solutions as efficiently as possible. The company is committed to developing not only life-changing drugs but also leaders in the field, encouraging hands-on engagement and the pursuit of innovation. BridgeBio actively seeks investment to help achieve its mission of providing solutions for unique patient populations with unmet needs. Headquartered in Palo Alto, CA, BridgeBio emphasizes bridging the gap between scientific advancements and patient care.

📋 Description

• 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 CROs and external vendors for compliance with proposals, quality standards, and timelines • Review external data • Manage drug forecasts and associated transactions • Integrate and liaise effectively with the CMC team • Provide formulation and clinical supply expertise and support for regulatory submissions, including IB, IND, and NDA • Develop complex formulations for pediatric indications • Work effectively with CDMOs • Manage clinical supply, formulation development, and manufacturing at CROs

🎯 Requirements

• PhD or advanced degree in Chemistry or Pharmacy • 7+ years of bio/pharmaceutical industry experience in formulation development and clinical supply • Expertise in formulation • Knowledge of PK/PD principles and ADME concepts • Knowledge of regulatory documentation and authorship • Knowledge of import/export sensitivities • Demonstrated ability to manage clinical supply, formulation development, and manufacturing at CROs • In-depth knowledge and understanding of CMC regulatory requirements for the US and EU • Ability to work effectively and collaboratively on cross-functional project teams in a fast-paced, dynamic environment under tight timelines • Hands-on experience in clinical trials management/study conduct, formulation development, and clinical trial manufacturing • Knowledge of commercial manufacture • Clear, concise communication style with ability to interact internally and externally • Willingness to take ownership of critical program deliverables

🏖️ Benefits

• Market-leading compensation • Annual performance bonus • Company equity • 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 • 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 • Opportunities for skill development and internal mobility • Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching • Financial rewards, peer-to-peer recognition, and growth opportunities