Position: Physician - Neurologist (OHT5)
Location(s): FDA’s White Oak Campus in Silver Spring, Maryland
Area of Consideration: U.S. Citizens
Travel Requirements: This position requires up to 25% or less.
Application Period: January 18, 2023 through February 15, 2023
Salary: Salary range is $165,000 - $250,000 and is commensurate with education and experience (Band C).
Special Notes: This position is being filled under an excepted hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of the authority. Additional information on 21st Century Cures Act can be found here.
The Center for Devices and Radiological Health (CDRH), a major regulatory component of the Food and Drug Administration (FDA) and the Department of Health and Human Services, is inviting applications for a Physician-Neurologist in the Office of Health Technology 5 (OHT5): Office of Neurological and Physical Medicine Devices, Office of Product Evaluation and Quality (OPEQ). OHT5 is responsible for the total product lifecycle (TPLC) review of neurological and physical medicine devices.
This position offers the opportunity to broadly impact and improve the quality of life of patients across many dimensions of health care. You will collaborate with a multidisciplinary team of clinicians, microbiologists, engineers, data scientists, and regulatory experts in the scientific, technical, and regulatory review of in neurological and physical medicine devices and products to assure their safety, effectiveness, performance, and reliability. Specifically, you will focus your efforts on the review of clinical assessments and studies, developing and evaluating strategies to improve patient safety, pre-market clinical trial/study data and post-market surveillance data, risk management, and adverse event patient data. You will be responsible for providing clinical leadership and exercising sound scientific and evidenced-based technical judgement in the review of in scope medical products throughout their total product lifecycle.
The Physician-Neurologist also performs the following duties:
- Provide expert medical and clinical consultation related to treating patients with neurodegenerative diseases including Alzheimer’s Disease, Movement Disorders including Parkinson’s Disease, Amyotrophic Lateral Sclerosis (ALS), amongst others.
- Provide guidance to sponsors and other organizations on the safety and adequacy of development plans for early feasibility clinical studies to larger pivotal clinical trials intended to establish safety and effectiveness.
- Evaluate proposed clinical trial protocol(s) for their ability to test safety and effectiveness of new medical devices under development.
- Collaborate with colleagues across the FDA and within HHS, such as the Centers for Disease Control and Prevention and the National Institutes of Health as needed to arrive at benefit/risk considerations that best reflect public health and regulatory considerations.
- Review and assess the safety implications from post-market surveillance adverse event reports and recommend appropriate regulatory courses of actions.
- Candidates may be required to lead teams for medical device submission reviews and/or provide consultations to teams depending upon the workload demands of the Office.
Professional Experience/Key Requirements:
To qualify for this position, you must demonstrate in your resume the necessary qualifying experience, which is equivalent to the following:
- Exercise expert medical and clinical experience in treating patients with neurodegenerative diseases (i.e. Alzheimer’s Disease, Movement Disorders including Parkinson’s Disease, Amyotrophic Lateral Sclerosis (ALS), etc.) in the review of neurological and physical medicine devices and products.
- Skill in effectively interpreting and presenting complex clinical, scientific, technical, and regulatory information and concepts, in both written and oral formats for a variety of audiences.
- Ability to build collaborative and mutually beneficial working relationships across a diverse cadre of internal and external customers and stakeholders.
- Knowledge of policies, procedures, and practices associated with the regulation of medical devices.
- Ability to build collaborative and mutually beneficial working relationships with a diverse cadre of customers and stakeholders.
Basic Qualifications: Physician, (GP-0602): A Doctor of Medicine or equivalent degree from a foreign medical school must provide education and medical knowledge equivalent to accredited schools in the United States. Evidence of equivalency to accredited schools in the United States is demonstrated by permanent certification by the Educational Commission for Foreign Medical Graduates, a fifth pathway certificate for Americans who completed premedical education in the United States and graduate education in a foreign country, or successful completion of the U.S. Medical Licensing Examination.
Licensure: Applicant must possess a current, active, full, and unrestricted license or registration as a Physician from a State, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States. It is highly desired that the prospective candidate has eligible Board Certification.
How to Apply:
Prior to applying, please see the following instructions:
- Submit an electronic resume or curriculum vitae, copy of your active medical license, copy of your transcripts (unofficial).
- Include Job Reference code “Physician-Neurologist (OHT5)” in the email subject line.
Conditions of Employment:
- United States Citizenship is required.
- One-year probationary period may be required.
- Background and/or Security investigation required.
- All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption.
- To ensure compliance with an applicable preliminary nationwide injunction, which may be supplemented, modified, or vacated, depending on the course of ongoing litigation, the Federal Government will take no action to implement or enforce the COVID-19 vaccination requirement pursuant to Executive Order 14043 on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees. Therefore, to the extent a federal job announcement includes the requirement that applicants must be fully vaccinated against COVID-19 pursuant to Executive Order 14043, that requirement does not currently apply. Federal agencies may request information regarding the vaccination status of selected applicants for the purposes of implementing other workplace safety protocols, such as protocols related to masking, physical distancing, testing, travel, and quarantine.
This is a bargaining unit position.
PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply to this announcement. Officers must follow the instructions for how to apply and include their most recent orders in addition to the required documents. If selected, candidates will be referred to (CC) personnel and not as candidates for a Cures appointment.
Equal Employment Opportunity Policy:
The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Equal Employment Opportunity (EEO) for federal employees & job applicants
Reasonable Accommodation Policy:
Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis.
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Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when:
- An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.
- An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.
- An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events.
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Learn more about disability employment and reasonable accommodations or how to contact an agency.
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FDA is an equal opportunity employer.