HJF is seeking a Chief Medical Officer to support to the Center for Neuroscience and Regenerative Medicine (CNRM). HJF provides scientific, technical and programmatic support services to CNRM. Responsible for assisting in the preparation of clinical trial protocols; the preparation of Investigational New Drug (IND) and other communications with the FDA and in ensuring clinical trial patient safety and protection, and oversight of the CNRM Clinical Trials Unit (CTU). Works closely with CNRM Program Directors and Research Cores to develop and implement CNRM funded research and CNRM collaborations across clinical sites. This position will report to a CNRM Director.
Serve as point of contact and subject matter expertise to support collaborative research across institutions, including military treatment facilities, by addressing regulatory and administrative requirements.
Participate in the review, planning and implementation of clinical trials including evaluating: hypothesis, objectives, study design, feasibility, regulatory requirements and identifying medical and logistical problems that may impede the study. Advise program management of the merits and deficiencies in the proposed study.
Provide subject matter expertise during protocol development. Participate in protocol review and ensure that any concerns raised are addressed by the Protocol Development Team in a timely manner.
Provide clinical expertise to assist in developing IND applications. Review serious adverse events (SAE) reports. Provide expert medical advice on the potential impact of SAEs on ongoing research. Sign-off on safety reports. Assist in the preparation of SAE reports submitted to the FDA. Evaluate annual IND reports for medical safety finding to the FDA.
Provide medical expertise in protocol follow up stages in the areas of subject safety and protection, reliability of study endpoint data. Make appropriate recommendations to ensure trials are conducted according to protocol.
Provide clinical and scientific expertise to assist with communications with the FDA, other government and non-government agencies, pharmaceutical companies, Data Safety Monitoring Boards, and other stakeholders.
Make site visits when needed to obtain data and information to assist Program in evaluating the site for ongoing and future programs.
Responsible for the coordination of CNRM Core Research Services related to clinical trial development and implementation.
Supervision of CNRM protocol development and regulatory staff.
Attend and participate in national/international scientific meetings/conferences, national meetings of professional societies and organizations in order to meet clinical network investigators and provide subject matter expertise. Attend clinical network steering committee meetings. Participate as a medical expert in protocol development gathering and present network information, as appropriate.
Prepares scientific papers for presentation at local and national meetings and for publication in medical and scientific periodicals.
Complete assigned Program tasks, including submission of status reports and attendance at meetings.
Evaluate data collection, quality control and/or data utilization methods used to study a medical problem or issue.
Apply new methods, approaches and technology or adaptation of existing methodologies to new and unusual situations.
Promote the development of field training programs.
Provide medical leadership for the implementation of integrated public health programs.
Foster compliance with all ethical guidelines for scientific studies and management of programs.
Performs other assignments as required.
Required Knowledge, Skills, and Abilities: Thorough knowledge of clinical medicine and the procedures and techniques necessary for performing research tasks; knowledge of medical science and the development of clinical research programs; experience in the design of clinical research trials; ability to communicate effectively; ability to make effective presentations and publish; excellent verbal, written and interpersonal skills. Experience in medical review of adverse events associated with clinical trials. Experience in traumatic brain injury and related disciplines such as neurology. Knowledge of DoD and NIH extramural activities related to clinical studies. Previous experience with TBI and/or Post Traumatic Stress Disorder (PTSD) preferred. Must be a US Citizen.
Minimum Experience: Six or more years of related experience.
Physical Capabilities: Bending, standing, and sitting.
Required Licenses, Certification or Registration: Licensure to practice medicine within the continental United States; Board certified or board eligible for certification in Neurology/Psychiatry, Internal Medicine, Emergency Medicine, Physical Medicine and Rehabilitation, or other related areas.
Work Environment: Office environment.
HJF is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.