Study Director/Director Clinical Operations

Employer
ContraFect
Location
Working from home
Posted
Oct 07, 2021
Ref
1416
Required Education
Bachelors Degree
Position Type
Full time

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. ContraFect is 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. ContraFect is using their 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 ContraFect’s history as we advance our direct lytic agent (DLA) platform of lysins and amurin peptides.  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 as a treatment for  MRSA bloodstream infections (bacteremia), including right-sided endocarditis, when used in addition to standard-of-care anti-staphylococcal antibiotics.  The exebacase Phase 3 study, known as the DISRUPT Study (“ Direct Lysis of Staph aureus Resistant Pathogen Trial”), is  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  BARDA, CARB-X, the Department of Defense,  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., while our amurin program targets Gram-negative ESKAPE pathogens.

ContraFect has been highly successful in raising significant capital to fund their continued commitment to innovative R&D.  This includes non-dilutive funding up to $86.8 million from BARDA for exebacase clinical development against S. aureus infections, $18.9 million from CARB-X for antibacterial research, $7.2 million from USAMRMC to advance CF-296 for osetomeyelitis and prosthetic joint infecitons, an additional $6.94 million from CARB-X to support the development of amurin platform against Gram-negative ESKAPE pathogens, and funding from the Cystic Fibrosis Foundation. 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 Study Director/Director, Clinical Operations is a key position responsible for the operational execution for ContraFect’s Early Discovery and CMC programs. The incumbent must have prior drug development experience (preferably with biologics) and will ensure seamless integration of operational activities and scientific imperatives to ensure execution, scientific excellence and delivery of programs within time, cost and quality parameters. This position has primary responsibility for the operations and completion of projects to meet ContraFect’s company objectives and in accordance with highest standards of quality, data integrity and compliance.

The successful candidate will ensure alignment across all internal and external contracted parties responsible for study conduct (e.g. within ContraFect’s Subteams and across Contract Research Organizations (CROs) and vendors) to ensure operational efficiency, adherence with the fully executed budget, and successful attainment of program milestones that are aligned with government grant commitments.

Key Responsibilities:

  • Provides CRO oversight to achieve program objectives and high-quality deliverables within established timelines and budgets.
  • Has responsibility for the operational conduct of the Company’s ongoing Phase 3 “DISRUPT” study.
  • Drive ongoing clinical operations management activities and projects. Responsible for management of activities related to the conduct of clinical trials.
  • Ensure clinical studies are conducted according to ICH GCP and applicable US regulations, as well as identifying risks, managing issues, and implementing corrective actions, as necessary.
  • Prepare study reports and updates for leadership meetings
  • Work on related clinical operations documents and publications as needed

Education/Experience/Skills:

  • 7-10+ years professional pharmaceutical development experience in the clinical operations area, with a minimum of 5 years leadership experience. Experience in conduct of Infectious Disease programs preferred.
  • BA/BS required, advanced degree with scientific or health-care training preferred.
  • Experienced in FDA regulations and other international regulatory agencies
  • Experience in the end to end conduct of Phase I-IV clinical trials. Experience with the conduct of on Phase 3 pivotal studies required.
  • Proven team member that can work unilaterally and collaboratively

ContraFect’s 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.

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.