Regulatory CMC Senior Director for an Early-Stage Vaccine Company

Client background

This small, privately-held biotechnology company is developing vaccines for a variety of infectious diseases including HIV, HCV, Ebola, and COVID-19. They are planning to file their first two CTAs this year in Canada and Europe.

Challenge

Their Chief Medical Officer was seeking CMC Regulatory support for their upcoming CTAs. They reached out to Dennis Partners for help finding a Regulatory CMC Contractor who could start right away to write their CMC sections.

Approach

Dennis Partners collaborated with the CMO to write the job description. Then we began searching for Regulatory CMC contractors and consultants who had strong vaccine experience.  We were able to find several available candidates who met the client’s qualifications within a few days of launching the search.  

Result

They picked the contractor with the strongest experience and he started working for the client within weeks of starting the search. He exceeded their expectations in the role, and after a few months they decided to offer him a permanent role at the company.  He accepted the offer and the client was elated!