Senior Medical Director/VP, Clinical Development
Remote, NY, USA | ContraFect Corporation
Industry:Pharmaceutical / Biotech
Job Description:59 people have viewed this job
Reports to: Chief Medical Officer & EVP R&D
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 clinical development. Earlier this year, the FDA granted Breakthrough Therapy designation to exebacase as a treatment forMRSA 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 Staphylococcus aureus Resistant Pathogen Trial”), isongoing 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. Our lead IND candidate, CF-370, is a lysin targeting MDR Pseudomonas aeruginosa, 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 our 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, an additional $6.94 million from CARB-X to support the development of the amurin platform against Gram-negative ESKAPE pathogens, and funding from the Cystic Fibrosis Foundation. ContraFect has also 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.
This leadership role will serve as the company’s clinical/medical expert on Infectious Disease and will be responsible for the design and execution of clinical programs for the company’s first in class, first in field portfolio of novel products.This Infectious Disease expert will be instrumental in developing the company’s pipeline and portfolio expansion strategy in close partnership with the Chief Medical Officer (CMO) and Head of Research and Development. The incumbent will work closely with the Chief Medical Officer and all relevant functions to ensure medical and scientific excellence and strategic alignment cross functionally.The successful candidate must be have a “hands on” approach to the delivery of clinical study programs, partnering closely with the Head of Clinical Development Operations to ensure scientific and executional excellence in all clinical programs.The incumbent will also play a key role in external medical communications related to the company’s novel Infectious Disease portfolio.
• Responsible for designing and implementing the clinical development strategy and clinical protocols and delivering high quality clinical programs, from first in human trials, through to full development (Phase 3 and potentially Phase 3b/4).
• Serves as the medical lead for clinical stage programs. Oversees all medical aspects of the operational conduct of clinical studies (e.g. safety/benefit risk determination, protocol deviation review, clinical quality, etc.), partnering closely with heads of clinical operations, pharmacovigilance, clinical quality, clinical microbiology and biometrics.
• Provides medical leadership for key areas of clinical operational strategy, particularly with respect to site selection, enrollment, feasibility, etc. and serves as primary, point of escalation for all issues identified which may affect the quality and integrity of clinical studies.
• Represents the company to all external stakeholders supporting the conduct of clinical trials, including CROs, clinical consultants, investigational sites, etc.
• Responsible for the medical integrity of clinical study reports and data interpretation/communication.
• Authors clinical sections of regulatory submissions (INDs, briefing books, BLAs, NDAs, etc.) and represents the company at regulatory meetings including presentation at Advisory Committee Meetings
• Serves as matrix leader of clinical program teams as medical leader of the internal Clinical Subteam.
• Serves as internal infectious disease subject matter expert, guiding development of target product profiles, draft product labeling, etc.
• Leads the development, chartering and conduct of key clinical oversight and advisory boards, including but not limited to Data Safety Monitoring Boards, Adjudication Committees, etc.
• Engages regularly with external disease area experts, clinical study investigators, regulators, health technology assessors, etc.
• Stays abreast of new developments in infectious disease therapeutic landscape and regulation which may affect the design and/or conduct of the company's clinical programs and proactively communicates this information internally.
• Actively seeks opportunities for external collaboration to advance the company's clinical programs.
Therapeutic Area Expert
• Represents company externally (e.g. at regulatory agency/ health authority meetings, to study investigators, at professional societies, government agencies, and among external experts).
• Proposes, establishes and leads external collaborations to address strategic and tactical needs of agreed Research and Development strategies.
• Authors medical content for and ensures medical accuracy of grant applications, publications (abstracts, manuscripts, oral presentations), regulatory filings and other external communications.
• Maintains up to date knowledge of the evolving Infectious Disease medical and therapeutic area landscape and shares this knowledge and insight cross functionally.
• Provides clinical guidance and/or training to corporate staff
• Participate on strategic planning sessions with executive team for the purpose of goal/milestone setting initiatives and design of roadmap to achieve targets
• Subspecialty training/board certification in Infectious Disease preferred
• 5+ years relevant professional work experience in Infectious Disease (clinical, medical or research) within the pharmaceutical/biotech industry or academic/clinical practice arena.
• 5+ years of experience in pharmaceutical drug development or equivalent experience (e.g. biotech), preference given to Infectious Disease experience.
• Demonstrated ability to successfully design, conduct and deliver the results of clinical studies
• Thorough knowledge of GCP and familiarity with FDA and international regulations as they apply to pharmaceutical drug development.
• Prior experience with regulatory submissions (e.g. IND, NDA, BLA, MAA) and engaging with regulatory authorities.
• Effective and collaborative leader able to manage multi-disciplinary teams directly and/or through influencing others.
• Ability to work in a cross-functional team environment and a flexible team-oriented perspective.
• Exemplary interpersonal and communication skills; excellent verbal and written communication skills.
• Demonstrated problem solving abilities and conflict resolution skills.
• Impact: Leadership role with major impact on company decision making.
• Decision Making: Independent, self-motivated leader with responsibility for exercising good judgment and making swift and decisive business decisions on the conduct of clinical programs.
• Problem Solving: Must exercise critical thinking and have strong analytic skills, utilizing clinical/scientific knowledge and drug development expertise on a consistent basis.
• Influence/Liaison: Highly visible role, influencing company strategy and decision making. Strong communication and influence skills, including consensus building capabilities.
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.
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