Regulatory CMC Director

Client background

This late-stage biotechnology company is developing first-in-class T Cell based cancer immunotherapies. They filed their first BLA this year, and have several other programs in clinical trials.

Challenge

The company recently acquired an approved interleukin-2 product used to promote T-cell activity prior to infusion of their immunotherapy programs. Therefore, they needed to hire a Regulatory CMC Director who could prepare and submit global post-approval CMC filings for this product and work closely with global health authorities regarding maintenance issues. 

Approach

Dennis Partners kicked off the search with HR and the hiring manager to better understand the required qualifications for the role.  We then developed a list of about 220 candidates who fit their specifications.  We recruited, screened, and presented five qualified candidates to our client within one week of starting the search.

Result

The client screened all five of the candidates by video, and then scheduled their top choice for a series of video interviews with several members of the Regulatory team.  The client presented a strong offer and the candidate accepted the position.  The entire process from the kickoff of the search until the offer was accepted was 45 days. And the candidate joined the company within 60 days of initiating this search.