Position Objective: Provide services as a Senior Scientific Program Manager (Part-Time) in support of the overall functions of the Director of Intramural Research (DIR), Laboratory of Malaria Immunology and Vaccinology (LMIV) within the National Institute of Allergy and Infectious Diseases (NIAID).
Duties and Responsibilities:
- Provide support to LMIV clinical team in developing and implementing U.S. and international clinical trial programs.
- Assist with discovery and development of novel vaccines against malaria.
- Actively participate and contribute to LMIV’s clinical activities includes Phase I studies of LMIV vaccines and experimental human infection studies in the United States and in Africa, as well as Phase IIb studies in Africa. International collaborations and clinical sites are active at several centers in Africa.
- Responsible for international collaboration, investigational agent development, and partnership with LMIV staff and medical teams at the study sites.
- Support the LMIV clinical trials team and interact with LMIV scientists, medical review boards, and regulatory offices.
- Provide expertise in the conduct of clinical trials under FDA guidelines, preferably with experience in the developing world; protocol development and preparation; interaction with ethical review boards and regulatory agencies; data and adverse event monitoring; and final study report preparation.
- Perform malaria patient clinical interviews, physical examination and examinations on malaria vaccination patients after vaccinations and/or treatments.
- Perform necessary clinical procedures, such as vaccinations, post vaccination evaluations, and consultation with doctors and nursing staff.
- Enter clinical documentation in malaria databases, NIH electronic medical records and regulatory paperwork.
- Communicate with patients and their outside healthcare-providers, NIH and extramural patients’ consultants.
- Maintain current medical license and NIH clinical privileges.
- Prepare regulatory paperwork (in collaboration with other team members such as research and regulatory nurse).
Basic Qualifications:
- MD degree with a minimum of two years’ experience working in medicine - having an M.D. from an accredited school in the United States or Canada or an M.D. or equivalent degree from a foreign medical school with permanent certification by the Educational Commission for Foreign Medical Graduates (ECFMG).
- Previous experience working with human patient enrolled in clinical trials.
- Background in medicine, malaria vaccines and malaria clinical trial conduct.
- Relevant experience and knowledge with regulatory authorities.
- Basic computer skills including experience with Microsoft Word and Excel. More advance experience e.g. familiarity with PowerPoint and other graphics programs.
- Must have a current Medical Degree and be licensed to practice medicine - have current license to practice medicine in the United States or must have all of the credentials required by the state of Maryland for licensing to allow the practice of medicine.
- Must be able to obtain NIH credentialing.
- Must have significant experience with malaria vaccine clinical trial design and implementation.
- Must have excellent communication skills including writing, speaking and presentation of data and information to various audiences.
- Must have experience with regulatory authorities as it pertains to the conduction of human clinical trials.
Minimum Qualifications:
- Good documentation and communication skills.
- Ability to communicate effectively, orally and in writing, with non-technical and technical staff.
- Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects
*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.
GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.
This position is contingent upon contract award.
