Position: Head of Preclinical Development
Reports to: EVP of Research and Development and Chief Medical Officer
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 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. CF-301, our lead compound, is the first and only bacteriophage-derived lysin (cell wall hydrolase) 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. CF-301 is currently being studied in a multinational, multicenter Phase 2 clinical trial for the treatment of S. aureus bacteremia including endocarditis. In addition to CF-301, we have an exciting pre-clinical and discovery pipeline of lysins targeting anti-biotic resistant Gram-positive and Gram-negative bacteria. Our primary focus is on developing treatments for bacteria designated by CDC and the WHO as urgent or serious threats of critical or high priority.
In addition, we are developing a triple antibody therapy for the potential treatment for serious influenza infections. We are using ContraFect's technical expertise to develop biotherapeutic products for infectious diseases that have high unmet medical needs, particularly products used in hospital-based markets.
The successful candidate will lead Preclinical Development at ContraFect. In that role, he/she will be responsible for strategic planning, execution and reporting of pre-clinical pharmacology and toxicology studies, and overseeing the strategic planning in allied disciplines (e.g. bioanalytics). In carrying out this role, the incumbent will partner closely with the VP of Research and will work with a broad range of experts in the field of Preclinical anti-infective drug development. The candidate must have experience and proven success in regulatory submissions and defense (e.g. IND and NDA/BLA, and/or MAA submissions) and must be able to represent the company to a broad range of external stakeholders including regulators, funding agencies, scientific experts, development partners and experts in the field. Preclinical Development has a central role in both Research and Development at ContraFect, so as to enable seamless transition of product candidates from discovery research to clinical development, an environment characterized by rapid, integrated decision making. The energetic environment at ContraFect will enable a successful candidate to use the full range of his/her skills, ranging from leadership and management to 'hands on' scientific problem solving, and play a pivotal role in the Company's pioneering discovery efforts and ultimate growth and development.
- This position holds accountability for the overarching strategy, execution and reporting of Contrafect's Preclinical development programs for product candidates from discovery through regulatory submission and approval. Specific responsibilities include but are not limited to:
- Lead the strategic design and execution of ContraFect's preclinical pharmacology and toxicology/toxicity programs in collaboration with a range of internal and external partners including: scientific and academic experts, research laboratories, consultants, co-development partners, and CROs.
- Work closely with clinical pharmacology, pharmacometrics and bioanalytics groups to ensure robust PK/PD data is generated to support dose selection for clinical programs, and ultimately NDA/BLA/MAA approvals.
- Partner with clinical pharmacology, pharmacometrics, bioanalytics and safety groups to conduct safety pharmacology and phamacodynamics and lead toxicity/safety assessment (e.g. for IND submissions).
- Develop long term bioanalytics strategy in collaboration with bioanalytics team members and external experts.
- Collaborate with CMC team to ensure coordination of manufacturing activities and support for toxicology and pharmacology studies.
- Serve as Preclinical Development subject matter expert on project teams supporting the discovery and development of novel biologic therapeutics in infectious diseases. Provide clear updates of Preclinical study design, execution and results relevant to project team programs. Keep abreast of novel scientific developments in the field, and share new information with project team and management as appropriate.
- Manage and oversee CROs in the design, conduct, analysis and interpretation of pharmacology and toxicology studies and ensure that studies are delivered within agreed quality, cost and timeline parameters:
- Coordinate CRO selection (e.g. draft RFPs, conduct capability assessments)
- Develop and review study protocols
- Ensure reagent generation, method development and sample analysis timelines are met
- Work closely with contracting team to ensure timely preparation of MSAs, SOWs, work orders, etc. Review and process invoices for approval
- Oversee assay development, validation and sample analyses
- Review study progress, and summarize data and finalize study reports
- Lead interactions with regulators regarding Preclinical Development and author relevant sections of regulatory submission documents (e.g. INDs, NDA/BLA, MAAs) as well as preclinical sections of Investigators Brochures, CTA applications, IMPDs, etc).
- Represent ContraFect externally at scientific meetings, regulatory agency meetings, grant defense and review meeting, partner interactions and with external experts, KOLs and other stakeholders.
- Author and present abstracts at scientific meetings and manuscripts as agreed with the Head of R+D and ContraFect senior leadership.
- Work with GLP Quality to ensure non-clinical quality and compliance and development of ContraFect SOPs to ensure compliance with all applicable regulations, SOPs, policies and guidelines, as needed.
- A PhD in Pharmacology, Toxicology or a related Life Sciences field and at least 10 years of relevant experience in the pharmaceutical drug development (e.g. at a pharmaceutical company, biotechnology company or CRO).
- Extensive experience and expertise in animal models for infectious disease drug development, including PK/PD, and demonstrated track record of successful delivery of completed preclinical programs.
- Experience with the generation of PK/PD data in the animal setting and the application of this information to support anti-infective drug development and approval.
- In depth understanding and experience in the design, development and conduct and interpretation of non-clinical toxicology and safety pharmacology studies. Experience with toxicological assessment of biologics (protein based therapies) strongly preferred.
- Broad experience in the development and validation of relevant assays on multiple technology platforms.
- Thorough knowledge of GLP standards, and solid working understanding of regulatory requirements for preclinical development of biologics and anti-bacterial products.
- Must have extensive experience with the design and conduct of animal models of bacterial infection. Similar experience with viral pathogens is a plus.
- Experience in the preclinical development of biologic compounds strongly preferred.
- Must have experience in the conduct of screening toxicity studies, as well IND-enabling toxicity/toxicokinetics and safety pharmacology program, including safety assessments.
- Demonstrated leadership and management skills (including both direct and dotted line reporting relationships).
- Must be able to see the big picture, and connect the dots, while maintaining sufficient focus on details.
- Ability to successfully work with a collaborative, fast‐paced project team in an entrepreneurial work environment.
- Ability to influence, negotiate and successfully communicate with both internal and external stakeholders.
- Excellent organizational, planning, and project management.
- Strong communication (oral and written) and interpersonal skills.
- Ability to present complex pharmacology and toxicology data to a wide range of audiences including: internal project teams, senior management, academic experts/leaders in the field, regulators and other key external decision makers (e.g. grant reviewers, etc).
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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