Director – Clinical Development

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🕒 Maio 15

🏄 California – Remoto

🏄 California – Remote

💵 $200.000 - $280.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Diretor

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Codera

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🧬 Biotecnologia

💊 Farmacêutico

🤝 B2B

Biotechnology • Pharmaceuticals • B2B

A Codera é uma empresa B2B que faz parceria com empresas de biotecnologia e farmacêuticas para fornecer expertise e infraestrutura de desenvolvimento de medicamentos de ponta a ponta. Ela apoia clientes em todo o ciclo de vida do desenvolvimento de medicamentos com serviços técnicos, operacionais e infraestrutura para ajudar a avançar os programas terapêuticos.

Descrição

• Support the planning and execution of clinical development programs, ensuring alignment with overall program strategy and timelines • Contribute to the evaluation and refinement of development strategies to mitigate risks and advance clinical assets efficiently • Participate in the planning, delivery and cross-functional coordination of clinical trials from early to late phases • Assist in the development, review and refinement of clinical trial protocols, ensuring scientific rigor, ethical conduct and regulatory compliance • Provide medical and clinical input throughout the clinical trial lifecycle, including safety monitoring, data interpretation and risk management • Partner with biometrics and medical writing to ensure clinical and nonclinical studies are designed, analyzed and summarized appropriately in accordance with timelines, good quality practices and applicable regulatory requirements • Collaborate with regulatory affairs and other departments to support regulatory strategies, clinical trial submissions and responses to health authorities • Support data analysis and reporting activities, contributing strategic insights to inform decision-making and regulatory submissions

🎯 Requisitos

• Bachelor’s Degree required • Advanced degree preferred • Minimum 6 years of clinical development experience within the biotechnology or pharmaceutical industry • Experience with multiple, complex programs or studies • Detailed understanding of end-to-end management of clinical trial conduct, clinical drug development and clinical trials operations • Deep understanding of global regulatory requirements and experience navigating clinical trials to approval • Outstanding written and verbal communication skills, including the ability to use clear language to explain complex ideas • Possess a willingness and ability to work hands-on in a detail-driven, fast-paced, entrepreneurial environment • Strategic agility with strong critical and logical thinking and ability to analyze problems • Ability to establish and maintain collaborative working relationships with internal and external stakeholders

🏖️ Benefícios

• employer sponsored insurance plans including medical, dental and vision coverage • generous paid time off • retirement plan options • additional wellness and professional development programs