Jobs

Chief Medical Officer at ReNetX Bio
New Haven*, CT, US
ReNetX Bio has an immediate opening for Chief Medical Officer responsible for successfully advancing the company’s lead development molecule AXER-204 in clinical development as a treatment for chronic spinal cord injury.

Chief Medical Officer for ReNetX Bio will possess an extensive track record of advancing clinical trials successfully. With a background in Neurology or other relevant specialty, the successful candidate will demonstrate a robust knowledge of Protocol design, experience in working with Key Opinion Leaders and overseeing, implementation, and execution of successful clinical trials. The candidate must also be a strong leader and strategic thinker skilled in effectively utilizing consultants and contract research organizations to conduct clinical studies.

Responsibilities:
• Responsible for clinical development strategies including Phase I through III, lifecycle management, medical affairs, safety responsibilities, scientific interactions with regulatory bodies, and interactions with corporate partner(s).
• Supervises and directs the activities of consultants and contract research organizations in all aspects of clinical development including Biostatistics, Clinical Operations, Regulatory and Medical Affairs, and Data Management.
• Leads and oversees the strategic definition and tactical development of clinical trials programs, including literature reviews, protocol writing, and interpretation of clinical data.
• Assists in the timely preparation of documents to be submitted to the FDA and other health authorities for review.
• Responsible for identification, selection, and recruitment of clinical investigators, resulting in negotiation of appropriate contracts.
• Ensures appropriate selection of contract research organizations and negotiation of contracts.
• Ensures that state-of-the-art scientific methods and ethical standards are applied to all aspects of clinical investigational trials.
• Ensures that all clinical trials are completed in keeping with approved timelines and budgets, with potential obstacles identified and solutions implemented to avoid delays.
• Ensures close coordination of efforts with colleagues and that all necessary people, systems, processes and materials required for clinical trials are available and appropriately prepared in accord with timelines.
• Ensures that clinical trials are conducted in accordance with applicable regulatory requirements and guidelines.
• Ensures timely medical review and reporting of adverse events.
• Ensures the timely preparation of presentations reporting results of clinical trials to internal and external audiences.
• Collaborates with colleagues in discovery research and preclinical development to advance development candidates into clinical investigations.
• Participates as an active member of the executive team of the company.

Skills, Education and Experience:
• MD, MD/PhD with 10+ years of experience in investigational drug development.
• Experience in a relevant therapeutic specialty, such as Neurology.
• Experience in the successful development, registration, and commercialization of new drug products is preferred.
• Experience in pharmaceutical or biotech industry working with Phase I - III clinical trials, and/or serving as principal investigator with a background in clinical trial design and protocol development.
• Familiarity with ICH guidelines and FDA requirements.
• A working knowledge of biostatistics as relevant to the design and analysis of clinical trials.
• Prior experience at senior levels working in and/or leading cross-functional teams.
• Team player with executive presence and demeanor coupled with excellent written and verbal communication skills as well as outstanding analytical abilities.
• Comfortable working both internally and externally with technical and medical experts in providing input into future drug development strategies.
• Independent, self-motivated individual with a highly entrepreneurial attitude coupled with self-confidence and a positive management style.

Availability:
Initial working relationship would be as a consultant advancing into a full-time role depending upon project needs. Must be available to work in the evenings and weekends, as required.

Can work from any location within the continental United States but must occasionally attend meetings at ReNetX Bio’s offices in New Haven, CT. Position will require frequent travel related to conduct of the clinical studies, scientific presentations, and fundraising.

Qualified candidates are invited to forward a cover letter and resume.