Medical Officer

Location
Rockville, MD, US
Posted
Feb 11, 2021
Ref
2020-6636
Hotbed
BioCapital
Required Education
Masters Degree/MBA
Position Type
Full time

Overview

We are currently searching for a Medical Officer to provide support to the National Institutes of Health (NIH). This opportunity is a full-time, temporary 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 HIV/AIDS, its co-infections 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.
  • Advise program management of merits and deficiencies in proposed clinical studies.
  • Provide subject matter expertise during protocol development leading to review at the Division level and ensure that the concerns raised during the review are addressed by the Protocol Development Team in a timely manner.
  • 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 for medical safety and report findings to RAB.
  • Provide medical expertise in protocol follow-up stages for subject safety and protection, reliability of study endpoint data and makes appropriate recommendations to leadership to ensure trials are conducted according to protocol.
  • Provide clinical and scientific information for preparing 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.
  • Preview serious adverse event (SAE) reports, providing expert medical advice for potential impact of SAEs in ongoing research and participates in the preparation of reports submitted to the FDA.
  • Attend and participate in national/international scientific meetings/conferences in order to stay abreast of current research findings and to interact with other investigators to promote collaborations.

 


Requirements

 

 

 

 

  • M.D. or equivalent degree; active Medical license preferred
  • Completed training in Internal Medicine or Pediatrics
  • Training in Infectious Diseases or Pulmonary Medicine preferred
  • Board Certification in Internal Medicine or Pediatrics, Infectious Diseases, or Pulmonary
  • Medicine preferred
  • Experience in in clinical trials, especially TB or other infectious diseases preferred
  • Experience in TB clinical care or studies preferred
  • The education, skills and relevant years of experience required for each support position are consistent with those identified as the minimum requirements for the labor categoriesspecified in the contract


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Company Description

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.