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Senior Director of Clinical Development

1 month ago

Reston, Virginia, United States Codera, LLC Full time

About Codera

Codera is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products.

Position Summary

The Senior Director of Clinical Development will oversee the clinical development strategy and execution of Codera's domestic and international drug development programs. This role will be responsible for medical oversight, including safety monitoring and pharmacovigilance.

Key Responsibilities

  • Develop and execute clinical development strategies to advance drug candidates through early-to-late development and regulatory submission
  • Lead the planning, delivery and leadership of clinical trials from early to late phases
  • 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

Requirements

  • 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
  • Excellent business acumen and demonstrated ability to engage, lead and align teams to achieve business and program objectives

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