Regulatory and Clinical Quality Coordinator
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 USAMRMCto 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 Regulatory and Clinical Quality Coordinator will report directly to the VP of Regulatory Affairs and Quality Systems and will provide support to the regulatory and quality group in the ContraFect organization. We are looking for a detail-oriented professional to join our Regulatory and Quality team as a Regulatory and Clinical Quality Coordinator.
The position will provide support to the Regulatory and Quality department that includes, scheduling departmental meetings, processing expense reports, and travel planning. Clinical quality activities will include working with the Clinical Development Operations team to track and file Sponsor eTMF records, coordinate new and maintenance of SOPs, schedule training, and maintain employee training records. Regulatory support will include providing assistance in preparing and coordinating IND amendments for FDA submission by liasing with external publishing vendor, and maintaining and tracking regulatory archives.
- Schedule meetings for the Regulatory and Quality department.
- Make travel arrangements and process expense reports.
- Collect Sponsor TMF documents from clinical development team members and transfer to CRO to include in official trial eTMF.
- Coordinates, manages, and tracks GxP training records for CF employees and contractors
- Coordinates and track SOPs, including new and updated versions, according to procedures.
- Maintains and updates Training Matrix at the direction of Head of GCP Quality and respective department heads
- Identify SOPs and forms requiring periodic updates
- Coordinate the review, format, and completion of updates to SOPs and forms.
- Receives, controls, and tracks quality documents per relevant processes and procedures, including training records.
- Assigns and monitors document numbers, and updates logs and databases, including current and legacy quality documents
- Assist in preparing routine IND amendments, by drafting cover letters and FDA Form1571s, upload of documents to publishing vendor, and maintaining tracking log of submissions.
University degree or equivalent in health sciences, nursing, pharmacy or related field preferred or equivalent experience.
Minimum of 5 years of work experience with 2 years experience working in regulated environment, preferably pharmaceutical industry. Demonstrate a working knowledge of internal SOP's, FDA/lCH guidelines to GCP's and regulatory compliance.
Knowledge of and direct experience with content of Trial Master File and prior regulatory experience desirable. Fundamental knowledge of the conduct of clinical trials is preferred.
Competent in use of MS Word, Excel, and PowerPoint, and Adobe Acrobat
Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. Must be able to work independently as part of virtual team.
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.