Vice President, Clinical Development

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🕒 Maio 2

🏄 California – Remoto

🏄 California – Remote

💵 $345.000 - $375.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Vice-presidente

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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

• Oversee clinical development programs including strategic planning and execution of clinical trials • Evaluate and refine development strategies to mitigate risks and expedite the advancement of assets • Direct the planning, delivery and leadership of clinical trials from early to late phases • Lead the development and refinement of clinical trial protocols, ensuring scientific rigor, ethical considerations and compliance with regulatory guidelines • Assume medical and clinical accountability throughout the clinical trial lifecycle, including safety monitoring, data interpretation and risk management • Oversee biometrics and medical writing to ensure all clinical and nonclinical studies are designed, analyzed and summarized appropriately in accordance with timelines, good quality practices and applicable regulatory requirements • Collaborate with the Vice President, Regulatory Affairs in the development and execution of regulatory strategies to facilitate successful clinical trial approvals and submissions • Direct data analysis and reporting activities, providing strategic insights to support decision-making and regulatory submissions

🎯 Requisitos

• Bachelor’s Degree required • Advanced degree preferred • Minimum 10 years of clinical development experience within the biotechnology or pharmaceutical industry, with at least 5 years’ experience leading teams in the progression of drug candidates through early-to-late development and regulatory submission • Experience overseeing 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 successful track record of navigating clinical trials to approval • Excellent business acumen and demonstrated ability to engage, lead and align teams to achieve business and program objectives • 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