General Job Description/Team Overview:
GenVivo seeks a Chief Medical Officer (CMO) to provide leadership and direction for GenVivo’s pipeline of clinical development programs currently focusing on cancer. The CMO will be responsible for the strategy, direction, and execution of the company’s clinical development plans. The CMO will be a key member of the senior management team, which determines and oversees research and drug development at GenVivo and sets the company's overall strategic direction. This is a unique opportunity to be a major contributor to the success of a well-positioned, well-financed growth-stage biotechnology company.
Primary Duties and Responsibilities (include but are not limited to):
· Direct the development of clinical strategies and plans to integrate GenVivo’s gene therapy based investigational products into the standard practice of oncology/hematology.
· Select and oversee the operation of clinical CROs utilized in support of the clinical trials.
· Orchestrate and manage clinical aspects of regulatory strategies and interactions with Global Health Authorities.
· Help select and lead interactions with key opinion leaders (KOLs), principal investigators, cooperative groups, and other clinical stakeholders.
· Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results.
· Provide clinical support and work with other members of the management team to develop and communicate the overall corporate strategy.
· Represent the company and its programs to external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partners.
· Perform other duties as assigned.
· MD with Board Certification and specialty training in hematology/oncology preferred.
· > 5 years’ experience in clinical practice treating patients and pharmaceutical and/or biotechnology industry experience with a sponsor working on investigational new drugs.
· Multiple years of management experience leading a clinical group.
· A proven success record in clinical research studies and trial design as well as the successful submission of INDs; marketing approval-directed filings (BLA’s, NDA’s, and MAA’s) experience preferred.
· Knowledge of relevant FDA and EMA regulations and guidelines; experience in interactions with FDA personnel is essential; experience in interactions with other health authorities is desirable.
· Experience with or strong knowledge of oncology drug development.
· Experience or knowledge of orphan or genetic rare disease drug development is a plus.
· Experience in translational medicine, clinical pharmacology, and early-stage development is desirable.
· Excellent knowledge of the competitive environment for drugs in the Hematology/Oncology marketplace and research and development pipelines.
· Thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines.
· Successful candidate will read, write, and speak fluent English, possess excellent communication skills, and be capable of articulating the company’s clinical and regulatory strategies and progress to a wide audience, including the CEO, the Board of Directors, Company employees, and the investor community.
· Must have excellent leadership and interpersonal skills; and be an effective team player who can engender credibility and confidence within and outside the company.
· Must be science- and data-driven.
· Must have a results-oriented work ethic and a positive, can-do attitude.
· A team builder management style is essential; must be willing and able to be “hands on”.
· Must have the highest personal values and ethical standards.
· Proficient in computer skills including Microsoft Office (Word, Excel, PowerPoint) and others as applicable.
· High degree of discretion dealing with confidential information.
· Ability and willingness to work flexible hours when needed.
Eligible to work in the U.S.
Job Type: Full-time
If you're interested in joining our Team, start by applying here and attaching your resume.