Codera, LLC · 5 hours ago
Vice President, Clinical Development
United States
Full-time
Remote
Director/Executive
10+ years expCodera, LLC is a life-sciences focused investment company that provides in-house end-to-end drug development for its portfolio companies. The Vice President, Clinical Development will oversee the clinical development strategy and execution of drug development programs, ensuring compliance with regulatory guidelines and leading clinical trials from planning to execution.
Biotechnology
No H1B
Responsibilities
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
Qualification
Required
Bachelor's Degree required
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
Preferred
Advanced degree preferred
Company
Codera, LLC
Codera is a Tang Capital company that provides in-house end-to-end drug development capabilities for its portfolio companies.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase