Vice President, Clinical Development

Visa Hunt; United States; On-site; USD 345,000 - 375,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Professional development

Job summary

Codera, a Tang Capital company, seeks a Vice President of Clinical Development to steer regulatory strategy and execution for domestic and international programs. You will oversee biometrics, medical writing, safety monitoring and pharmacovigilance across asset portfolios, reporting to the Chief Development Officer, with broad global oversight.

You will guide trials from early to late phases, ensure regulatory submissions are rigorous, and lead teams to deliver high-quality data and analyses.

Qualifications

• 10+ years of clinical development experience in biotech/pharma.
• Experience leading teams through early-to-late development and regulatory submission.
• Deep knowledge of global regulatory requirements and trial-to-approval processes.

Responsibilities

• Oversee clinical development programs including strategic planning and execution of clinical trials.
• Evaluate and refine development strategies to mitigate risks and expedite assets.
• Direct planning, delivery and leadership of clinical trials from early to late phases.
• Lead development of trial protocols with scientific rigor and regulatory compliance.
• Assume medical and clinical accountability, including safety monitoring and risk management.
• Oversee biometrics and medical writing to summarize studies per timelines and quality standards.
• Collaborate with Regulatory Affairs to enable trial approvals and submissions.
• Direct data analysis and reporting to support decision-making and submissions.

Skills

Leadership

Strategic thinking

Regulatory knowledge

Cross-functional collaboration

Communication

Education

Bachelor's Degree

Advanced degree preferred

Job description

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

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.

Tang Capital provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Tang Capital participate in E-Verify. All newly hired employees are required to complete the E-Verify process as part of their employment eligibility verification.

Salary: $345,000 - $375,000

Originally posted on Himalayas