Vice President, Clinical Development

About Codera

Codera is a Tang Capital company that provides in-house end-to-end drug development for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products.

Position Summary

The Vice President, Clinical Development will oversee the clinical development strategy and execution of Codera’s domestic and international drug development programs. Reporting to the Chief Development Officer, the Vice President, Clinical Development will lead the clinical development of our clinical assets with a strong and successful background in regulatory strategies and broad experience overseeing biometrics and medical writing to produce high-quality data, thoughtful data analyses and clear and concise regulatory submissions. This role will be responsible for medical oversite including safety monitoring and pharmacovigilance.

Essential Duties and 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

Qualifications

• 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

Codera, LLC is an Equal Opportunity Employer. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, veteran status, or any other legally protected status.

Codera, LLC participates in the E-Verify program. Candidates must be authorized to work in the United States.

This job description is not intended to be an exhaustive list of duties, responsibilities, or qualifications. The company reserves the right to modify duties or requirements at any time.