Director of CMC Regulatory

ContraFect Corporation, a late-stage clinical biotechnology company focused on the discovery and development of biotherapeutics for life-threatening, drug-resistant infectious diseases is located in Westchester County, near New York City. We are dedicated to innovative drug development, leveraging novel technologies to create new therapies that address the high unmet medical needs of patients suffering from serious, antibiotic-resistant infections for which there are limited available treatment options. We are using ContraFect?s technical expertise to develop biotherapeutics for serious bacterial infections, including those caused by MDR and XDR strains that have high unmet medical needs, particularly products used in hospital-based markets.

An opportunity is available to grow with us in an environment that is both challenging and energetic. ContraFect is seeking self-motivated and collaborative individuals to join our team and to contribute their talent and expertise to the team. We are looking for positive individuals who will add the strength of their personality to our committed and dedicated employee base and contribute to the development of novel therapeutic agents which have the potential to change the therapeutic landscape for treating serious infections.

It is an exciting time in our Company?s history as we advance our direct lytic agent (DLA) platform of lysins and amurin peptides into the clinic. Exebacase (CF-301), our lead lysin, is the first and only direct lytic agent to report promising results in Phase 2 and to advance to Phase 3 of development. Earlier this year, the FDA granted Breakthrough Therapy designation to exebacase for development as a treatment for MRSA bloodstream infections (bacteremia), including right-sided endocarditis, when used in addition to standard-of-care (SOC) anti-staphylococcal antibiotics. The exebacase Phase 3 study, known as the DISRUPT Study (? Direct Lysis of Staph aureus Resistant Pathogen Trial?) ongoing in the United States and will serve as the single pivotal trial to support the BLA. ContraFect also has an active discovery pipeline of DLAs discovered at ContraFect which are progressing towards the clinic with support from major funding agencies including the Department of Defense, CARB-X and the Cystic Fibrosis Foundation. Our lead IND candidate, CF-370, a lysin targets MDR Pseudomonas aeruginosa, a bacteria identified as a serious threat in the CDC?s Antibiotic Threats in the US, 2019 report.

ContraFect has been highly successful in raising significant capital to fund their continued commitment to innovative R&D. This includes non-dilutive funding from the Cystic Fibrosis foundation, $18.9 million from CARB-X for antibacterial research, $7.2 million from USAMRMC to advance CF-296, and $6.94 million from CARB-X to support the development of amurin platform against all Gram-negative ESKAPE pathogens. Also, ContraFect has conducted numerous capital raises, including public and private offerings. The gross proceeds from the most recent public offering were approximately $52.5 million, and an additional $3 million from a concurrent private placement transaction with Pfizer, the pharmaceutical company?s second investment in ContraFect.

Position Summary:

The ideal candidate will have a proven track record of accomplishments in the life sciences/pharmaceutical/biotechnology industry. This role will work closely with other departments and requires a highly collaborative work ethic. This position is responsible for the leadership on the regulatory and manufacturing team in planning, preparing, and coordinating CMC documents submitted to global authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries. The incumbent will represent Regulatory CMC on ContraFect?s CMC Development/Commercial and Regulatory Affairs teams and will represent regulatory CMC at regulatory agency meetings.