Chief Medical Officer (AdvancedGroup_414592) San Diego, California

Job Number: 414592

Chief Medical Officer

The CMO will be working with the CEO on investor relations/ presentations/ strategy. They will be interacting with the FDA and attending RAC meetings.

Key Responsibilities:

  • Provide executive-level leadership for all medical activities and support all non-medical functions in the furthering of corporate goals.
  • Directly manage the conduct of a comprehensive clinical development plan, including clinical trials in multiple indications, investigator interactions, KOL activities, safety monitoring, publication strategy, and NDA preparation, submission and defense.
  • Work closely with regulatory staff to ensure proper collection, preparation and submission of all regulatory correspondence. Lead telephonic and in-person discussions with FDA regarding product candidate(s).
  • Partner with existing staff and consultants to optimize cross-functional operations, including CMC, QC/Analytical, QA, Marketing, Business Development, Legal Departments.
  • Represent the company at selected conferences, road shows, business development and other external events, as needed.

 

Ideal candidates will have the following:

  • Demonstrated success negotiating with FDA, including preparing information packages for and leading discussions with the Agency
  • Ability to evaluate potential study sites for participation in clinical studies
  • Awareness of on-going clinical trials and compounds in development in relevant indications
  • Practical understanding of the hospital environment, including ED treatment practices and facility economics
  • Eagerness to work in a cross-functional team environment
  • Commercial-minded, with an appreciation of the role of the clinical function in supporting larger program and/or corporate-level decisions
  • Ability to obtain insights from opinion leaders to further product development
  • Self-starter “hands-on” attitude, with comfort working in fast-paced, small company environment with limited administrative support.

 

Experience:

  • Must be an MD with an oncology background.
  • Will consider foreign MD
  • Must be in San Diego, or they would need to relocate to San Diego.