Associate Director – Pharmaceutical Development

🕒 6 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $223.000 - $239.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Diretor

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BridgeBio

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2015

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

Healthcare • Biotechnology • Pharmaceuticals

A BridgeBio é uma empresa de biotecnologia focada em projetar medicamentos transformadores para pacientes com doenças genéticas. Ela emprega uma abordagem inovadora para o desenvolvimento de medicamentos, integrando finanças à ciência para oferecer soluções da forma mais eficiente possível. A empresa está comprometida em desenvolver não só medicamentos que mudam vidas, mas também líderes na área, incentivando o envolvimento prático e a busca por inovação. A BridgeBio busca ativamente investimentos para ajudar a alcançar sua missão de fornecer soluções para populações de pacientes únicas com necessidades não atendidas. Com sede em Palo Alto, CA, a BridgeBio enfatiza a conexão entre avanços científicos e cuidados com o paciente.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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