We are currently searching for a Medical Officer to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Rockville, MD.
Duties & Responsibilities
- Participate in the review, planning and implementation of clinical trials for the treatment and/or prevention of COVID-19 and/or related co-morbidities. This includes evaluating the hypothesis, objectives, study design, feasibility, and regulatory requirements, as well as identifying medical and logistical problems that may impede a study.
- Work with the protocol team, network leadership, PPD leadership and other trial stakeholders to address issues and problems in a timely manner.
- Advise program management of merits and deficiencies in proposed clinical studies.
- Lead special projects and initiatives in support of the studies in the program portfolio. Set objectives and project plans and ensure delivery.
- Provide clinical expertise to assist in developing Investigational New Drug (IND) applications. Individuals providing this expertise will be named as reviewer of information relevant to the safety of the drug in question, on line 15 and 16 of the IND application (FDA Form 1571).
- Evaluate annual IND annual reports and other trial related reports for medical safety and general study performance.
- Provide clinical and scientific information for preparing program communications to the Food and Drug Administration (FDA), other government and nongovernmental agencies, pharmaceutical companies and Data Safety Monitoring Boards.
- Conduct site visits, when necessary, to obtain additional data and information for use by federal staff, in the consideration and evaluation of ongoing and future programs.
- Review serious adverse event (SAE) reports, provides expert medical advice for potential impact of SAEs in ongoing research and participate in the preparation of reports submitted to the FDA.
- MD degree in a related field is required.
- Minimum of two (2) years of experience working directly in a clinical/medical setting.
- Demonstrates experience with medical research, preferably involving, clinical development investigations.
- Experience working with COVID-19 treatment and prevention studies, useful.
- Experience evaluating adverse events and presenting research and investigational findings to peers, senior level officials, the FDA, Data Safety Monitoring Boards, pharmaceutical companies, and other government and non-government agencies.
- Experience assisting in the development of Investigational New Drug (IND) applications.
- Due to our contractual requirements and federal orders, including an Executive Order from the White House and an emergency regulation from the Centers for Medicare & Medicaid Services (CMS), the position for which you are applying requires that you provide proof of your vaccination status. If you are unable to receive the COVID-19 vaccine for medical reasons or because of a sincerely held religious belief, you may request an exemption from the vaccination requirement which shall be reviewed after the submission of requested documentation. If an accommodation is granted, the conditions may include weekly testing and masking. All Guidehouse employees also agree to follow any additional health and safety mitigation policies that may be required in the workplace.
We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.
The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth.
What you’ll get…
- Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
- Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
- Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
- Discovery! With our tuition assistance and training programs, we support your career advancement.
- Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
- Support! Working parents and busy professionals – we’ve got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
- Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
- A Voice! A unique culture where you can influence decisions and have your voice heard.
We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.