Position: Director of CMC Regulatory
REPORTING TO: VP Regulatory Affairs and Quality Systems
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.
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.
- Lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks for a rapidly growing biotech company.
- Provide hands-on leadership for the development of the CMC regulatory strategy for global submissions. These submissions include IND/CTA, and BLA, and MAA regulatory filings in the eCTD format.
- Develop and manage the content, preparation, and review of CMC submission documents, registration dossiers, and responses to health authorities with other relevant line functions.
- Responsible for the regulatory evaluation of CMC change controls.
- Represent Regulatory CMC on CMC development/commercial and Regulatory Affairs team. Interact with regulatory agencies and represent CMC at regulatory agency meetings.
- BS/BA degree in Scientific Discipline (Masters or higher preferred) with 8-10 years in the pharmaceutical industry or in CRO, including at least 8 years CMC regulatory experience
- Must have demonstrated demonstrated record of accomplishments in the life sciences industry expanding from a clinical stage companies through to commercialization.
- Experienced leadership in preparing CMC regulatory documents (BLA, MAA, CTD, supplements, responses and IND/CTAs).
- Strong leadership in working with multiple functional areas in a fast-paced matrixed team environment, including functional team members, company management, and external vendors and contract organizations
- Detail oriented with strong verbal and written communication skills; ability to clearly articulate analytical, critical-thinking skills, and regulatory viewpoints to diverse internal and external audiences including executive leadership
- Knowledge of GxP, ICH, FDA, EMA and other global regulations and guidances
- Extensive experience leading regulatory CMC strategy and input for biologics development programs.
- Candidates must have strong entrepreneurial orientation along with teamwork skills and an absolute commitment to competing with the highest level of integrity in a remote/virtual working environment.
Respect. People matter.
Patient- Focus. Act with urgency and passion to save lives.
Leadership. Set high standards, and empower others to do the same.
Innovation. Challenge the status quo to deliver solutions.
Collaboration. Work together to achieve our vision.
Quality. Strive for excellence in all that we do.
Integrity. Courage to be honest, ethical, and transparent.
ContraFect does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
Please fill out the form below to submit your resume.