Director of GCP Quality

Employer
ContraFect
Location
Yonkers, NY, United States
Posted
Apr 04, 2021
Ref
1378
Discipline
Quality, Quality Control
Hotbed
Pharm Country
Required Education
Other
Position Type
Full time
Location: Remote

REPORTING TO: VP Regulatory Affairs and Quality Systems

Background

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.

Position Summary:

The ideal candidate will have a track record of accomplishments in the life sciences/pharmaceutical/biotechnology industry. This role will work closely with other departments and requires highly collaborative work ethic. This position is responsible for the leadership on the Clinical Development Team to provide oversight and ensure adherence to GCP Quality compliance. This includes but is not limited to hosting Regulatory Inspections as well as third party audits and managing the site response to any adverse findings including CAPA completion on time and in full. Define and execute improvements to the Quality Management System with cross functional and cross-site team members.

Key Responsibilities:
  • Serve as GCP Quality team member on the Clinical Study Team – prepare updates on quality issues; provide input to discussions which may involved GCP quality issues by communicating proactively and effectively
  • Collaborate with Clinical Development and Clinical Operations functions to confirm adherence to GCP compliance throughout all stages of clinical trial conduct including, but not limited to, core study execution documents, clinical trial sponsor oversight, issue escalation, internal/external audit support.
  • Manage QA reviews of essential clinical trial documents (manuals, study plans) for compliance with regulations.
  • Develop, implement, and maintain standards, policies, and procedures for GCP regulatory compliance
  • Manage/oversee GCP SOP training of clinical staff
  • Support the preparation and conduct of clinical inspections by Regulatory Agencies, such as BIMO Audits, and Clinical Sponsor Audits.
  • Plan/conduct Quality audits (qualification, requalification, and for cause) for all vendors supporting the clinical trials and related activities being conducted in accordance with GCPs
  • Review relevant vendor quality management plans
  • Participate in the evaluation and selection of CROs and other clinical vendors
  • Investigate potential/suspected clinical quality issues, escalate to Head of Quality and/or Quality committee as appropriate
  • Lead/participate in quality and compliance improvement initiatives within and outside of Clinical Development/Clinical Operations departments
  • Maintains a focus of performance with view of continuous improvement
  • Expected to operate independently and highly autonomously; accountable to proactively fulfill tasks and achieve results within assigned timelines.

Education/Experience/Skills:
  • Bachelor of Science degree or equivalent combination of education and work experience.
  • Minimum of 10 years industry experience with a proven track record of having managed GCP Quality functions through all Phases of clinical development.
  • Demonstrated leadership regarding the preparedness and participation in audits by external Regulatory Agencies to support NDA/BLA/MAA approvals.
  • The successful candidate for the position of Director of GCP Quality must have a demonstrated record of accomplishments in the life sciences industry.
  • Candidates must bring a strong entrepreneurial orientation along with teamwork skills and an absolute commitment to competing with the highest level of integrity in a remote working environment.

Our Values:
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.