Background
ContraFect Corporation, a clinical-stage biotechnology company focused on the discovery and development of protein therapeutics for life-threatening, drug-resistant infectious diseases.
We are committed to innovative drug development, leading the way with novel technologies to create new therapies that address the high unmet medical needs of patients suffering from serious infections for which there are limited available treatment options.
The company is located in Westchester County, near New York City.
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.
We are looking for positive individuals who will add 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.
Exebacase, our lead compound, is the first and only bacteriophage-derived lysin (cell wall hydrolase) to enter clinical trials in the US.
Exebacase, which targets Staphylococcus aureus, including MRSA, is the first of a new class of protein-based therapeutics for the treatment of serious bacterial infections.
Exebacase has recently been granted Breakthrough Therapy designation by the FDA and is currently being studied in a Phase 3 clinical trial for the treatment of S.
aureus bacteremia including endocarditis.
In addition to exebacase, we have an exciting pre-clinical and discovery pipeline of lysins and amurin peptides targeting antibiotic resistant Gram-positive and Gram-negative bacteria.
Our primary focus is developing potential treatments for bacteria designated by CDC and the WHO as urgent or serious threats of critical or high priority.
Position Summary:
Seeking an experienced toxicologist to provide support for conducting toxicology studies at CROs.
Roles and responsibilities include:
• Prepare/Review draft toxicology protocols
• Manage interactions between the company and toxicology CROs
• Maintain a calendar of study related milestones, and follow up with responsible parties to ensure timely delivery
• Track and maintain study specific milestones including study updates, data and documents,
• Responsible for coordination of all toxicology studies particularly those conducted under GLP
• Conduct monitoring visits of CROs at appropriate times during on-going studies
• Work closely with relevant colleagues and CROs to coordinate and track all study-related documentation, specimen shipment, reporting timelines and archiving by maintaining appropriate file management and document control for assigned programs
• Review raw data throughout the various stages of a study for clerical/technical errors, thoroughness and consistency, and adherence to SOPs, protocol specifications and compliance with Good Laboratory Practices (GLPs), as appropriate.
Coordinate correction of raw data with appropriate staff.
Report any deviations to the Study Director
• Review and critically evaluate toxicology draft study reports including data verification as needed and assist in resolution of comments
• Generate summary text and data tables for inclusion in regulatory submissions
• Provide assistance with archiving and preparation of studies for finalization
• Support the preclinical team with the monitoring, tracking and communication of study milestones throughout departments
Job Requirements:
• DABT or minimum of Master’s degree (or equivalent experience) in life sciences (e.g., Chemistry, Biology, Biochemistry or related discipline)
• 3-5 years of experience managing toxicology studies conducted at CRO site
• Good experience preparing and reviewing toxicology study protocols and study reports
• Excellent organizational, planning, and multi-tasking skills
• Strong communication (oral and written) and interpersonal skills
• Strong knowledge in scientific information retrieval
• Past experience working with small protein molecules is a plus
Specific Skills:
• Must be organized, adaptive, and detail oriented with the ability to multi-task
• Demonstrated ability of detail orientation and accuracy
• Demonstrated ability to be productive and successful in an entrepreneurial work environment
• Computer experience including Excel, Word, PowerPoint, Outlook, Project, literature reference management systems, and Adobe Acrobat are required, with a willingness to expand computer knowledge.
Database experience a plus
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.