Clinical Development Strategist

3 weeks ago


Reston, Virginia, United States Codera, LLC Full time

About Codera

Codera is a leading life sciences company that provides end-to-end drug development for its portfolio companies. As a Tang Capital company, Codera benefits from Tang Capital’s expertise in investing in and financing companies that develop and commercialize pharmaceutical products.

Position Summary

The Vice President, Clinical Development will lead the clinical development strategy and execution of Codera’s domestic and international drug development programs. This role will oversee the planning and execution of clinical trials, evaluating and refining development strategies to mitigate risks and expedite the advancement of assets.

Key Responsibilities

  • Develop and execute clinical development strategies to ensure successful drug development and regulatory approval
  • Lead the planning, delivery, and leadership of clinical trials from early to late phases
  • Collaborate with cross-functional teams to develop and refine 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
  • 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

Codera, LLC is an equal opportunity employer. Codera, LLC participates in E-verify.



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