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
The job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required. They may change, or new ones may be assigned at any time with or without notice.
The estimated annual base salary for this position is $345,000 - $375,000, commensurate with experience and skills. This role may be eligible for discretionary bonuses and other incentive programs.
Tang Capital provides a comprehensive benefits package designed to support employees' physical, mental and financial health and includes employer sponsored insurance plans including medical, dental and vision coverage; generous paid time off; retirement plan options and additional wellness and professional development programs.
