Position: Director, Toxicology Drug Development (Biologics)
REPORTING TO: Executive Director of Translational Sciences and Toxicology
ContraFect Corporation, a clinical-stage biotechnology company focused on the discovery and development of protein therapeutics and antibody products for life-threatening, drug-resistant infectious diseases. 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 infections for which there are limited available treatment options. The company has locations in both Westchester County, near New York City, and Cambridge, Massachusetts.
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. CF-301, our lead compound, is the first and only bacteriophage-derived lysin to enter clinical trials in the US. CF-301, which targets Staphylococcus aureus, including MRSA, is the first of a new class of protein-based therapeutics for the treatment of serious bacterial infections. In addition, we are developing a triple antibody therapy for the treatment for serious influenza infections. We are using ContraFect’s technical expertise to develop bio-therapeutic products for infectious diseases that have high unmet medical needs, particularly products used in hospital-based markets.
This successful candidate will provide scientific leadership and play a pivotal role in developing the nonclinical strategy. The incumbent will design, implement, interpret and report data from nonclinical and toxicology, toxicokinetic, and immunogenicity studies for two internal first-in-class/first-in-field anti-infective protein therapeutics, ranging in development stage from late stage research through clinical development. The individual will be an accomplished nonclinical development scientist with biologics experience and a proven track record of significant contributions to project goals and problem solving.
The core responsibilities of this position include development and execution of nonclinical drug development strategies, as well as design and oversight of outsourced nonclinical studies (toxicology, safety pharmacology, immunological and pharmacokinetics studies) at Contract Research Organizations (CROs). In this role, the individual will have the opportunity to not only lead efforts to characterize biologic drug candidates’ toxicity, but also play a pivotal role in the Company’s development by providing support for nonclinical and clinical development programs. The candidate must have direct experience designing, managing and reporting results from toxicology and other safety studies, managing external CROs, and drafting nonclinical sections for regulatory submission. This individual must work collaboratively with internal and external cross-functional teams, collaborators, CROs and consultants to map complete development pathways for each drug candidate.
- Serve as a toxicology and preclinical scientific subject matter expert providing project support including developing program nonclinical strategies and reporting key program nonclinical milestones and timelines to project teams.
- Work with cross-functional partners to establish project success criteria, monitor project progress, and communicate information to management.
- Function as study monitor for preclinical studies at contract laboratories by designing, monitoring and overseeing reporting of studies conducted by CROs.
- Summarize, analyze and interpret study results and communicate information to project teams and management.
- Manage direct reports and collaborate with Bioanalytical, DMPK, Research and Clinical cross-functional team members.
- Ensure quality and compliance with applicable policies, standard operating procedures, regulations and guidances (FDA, EMA, GLP, OECD, ICH, etc.).
- Develop regulatory submission documents (Meeting requests, Briefing packages, presentations, etc.) for interaction with regulatory agencies (i.e. FDA, EMEA, MHRA).
- Demonstrate strong understanding of bioanalytical assays, immunogenicity assays and DMPK for bio-therapeutics as it applies to nonclinical study designs.
- Assist with writing and reviewing SOPs and ensuring compliance with all applicable regulations, SOPs, policies and guidelines.
- Ph.D. in Toxicology (or a closely related field and/or relevant training) with a minimum of 10 years of industry experience conducting all phases of drug safety evaluation for bio-therapeutics is required.
- Previous anti-infective experience is desired.
- Excellent organizational, planning, and multi-tasking skills; ability to prioritize program timelines in a fast-paced work environment while adhering to quality compliance requirements.
- Ability to build and foster cross-functional collaborations both within and external to the company.
- Established ability to interact with various regulatory agencies.
- Broad knowledge of R&D operations including Quality, Compliance, Manufacturing, Product Development, and Regulatory Affairs is desirable.
- Must be highly motivated and organized with excellent oral, written communication and presentation skills.
- This position may require up to 10% annual travel both domestic and international.
- Must be adaptive and detail oriented.
- Ability to successfully work with a collaborative, fast‐paced project team in an entrepreneurial work environment.
- Ability to influence, negotiate and communicate with both internal and external stakeholders.
- 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.
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.
Salary: Commensurate with experience.
No phone calls, please.
ContraFect Corporation is an equal opportunity employer. We recognize the power and importance of a diverse employee population and welcome applicants with various experiences and backgrounds.
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