Medical Officer - Medical Oncologist

Tunnell Government Services • Bethesda, MD

4h • Remote

About The Position

Tunnell Government Services, Inc. provides professional and scientific services to the FDA Center for Devices and Radiological Health (CDRH), whose mission is to protect and promote public health by ensuring timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Tunnell is seeking an expert consultant to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise and training in clinical medicine and medical oncology, as relevant to medical devices. The role involves providing consultation related to supporting medical device reviews, participating in meetings, coordinating with stakeholders, developing written reviews and correspondence, performing research, conducting data analysis, writing detailed documents and reports, and executing other administrative office tasks related to CDRH’s projects.

Requirements

• Possess a Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States
• Possess a current, active, full, and unrestricted medical license or registration as a Physician to practice medicine in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States
• At least ten (10) years of relevant clinical experience
• Certification from a U.S. relevant specialty board organization, e.g., certification in Medical Oncology by the American Board of Internal Medicine (ABIM), etc.
• Thorough understanding of current clinical practices in medical oncology, including diagnosis and treatment, and current/emerging trends in practice
• Expert in function and utilization of medical devices commonly used as part of oncology (e.g., treatment devices [infusion pumps, implantable venous access devices, aseptic formulation equipment] diagnostic and monitoring tools [imaging systems, biopsy tools, diagnostic sets, lab equipment], supportive and safety devices (oncology treatment chairs/beds, sterile processing equipment, defibrillators), advanced technologies (AI-based diagnostic software, interventional radiology tools)
• Ability to communicate well with others using excellent written and verbal communication skills
• Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel
• Must be a US Citizen or a Full Green Card holder

Nice To Haves

• Familiarity with FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 864 – Hematology and Pathology, 21CFR Part 866 – Immunology and Microbiology), and guidances

Responsibilities

• Provide consultation related to supporting medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions)
• Participate in meetings and teleconferences
• Coordinate meetings with internal and external stakeholders
• Develop written reviews and correspondence
• Perform research
• Conduct data analysis
• Write detailed documents and reports
• Execute other administrative office tasks related to CDRH’s projects

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 11-50 employees