Vice President, Clinical Development

Job not on LinkedIn

🕒 May 2

🏄 California – Remote

🏄 California – Remote

💵 $345k - $375k / year

⏰ Full Time

🔴 Lead

👔 Vice President

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Codera

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Codera is a B2B company that partners with biotechnology and pharmaceutical companies to provide end-to-end drug development expertise and infrastructure. It supports clients across the drug development lifecycle with technical, operational, and infrastructure services to help advance therapeutic programs.

📋 Description

• 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

🎯 Requirements

• 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.

🏖️ Benefits

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