Travel Requirements: This position requires up to 25% travel.
Application Period: November 30, 2021 through December 29, 2021
Salary: Salary is commensurate with education, experience and comparable market pay and starts at the $195,000 range.
Conditions of Employment: United States Citizenship is required.
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 Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.
The mission of CDRH is to protect and promote the public health by performing essential public health tasks by making sure that medical devices and radiological health products are safe for people in the United States. OPEQ assures patients have access to high quality, safe and effective products throughout the total product lifecycle by implementing program areas through which medical devices are evaluated or cleared for clinical investigations and marketing. OCEA is responsible for the development of policy related to CDRH’s oversight and regulation of clinical trials and other sources of clinical evidence for medical devices. This includes development and implementation of policies related to human subject protection, good clinical practice, and appropriate collection of real-world evidence (RWE).
Reporting directly to the OCEA Office Deputy Director, you will serve as program manager and primary contact medical device clinical issues. You will serve as a senior Physician advisor to the Office Director, Super Office Director, and other OPEQ and CDRH leadership. Also, the incumbent provides senior advice and leadership to a scientific, clinical, professional, and technical staff throughout the Office. The Chief Physician is a nationally and internationally recognized clinician with a specialty emphasis on clinical trial design and evaluation, and quality control procedures.
The Chief Physician also performs the following duties:
Serve as the clinical authority in providing support to device specific offices in reviewing and evaluating clinical and research findings, real-world clinical evidence, analyses, laboratory and clinical behavior, and the impact of these factors and properties on the new safety and effectiveness of medical devices and provides clinical and senior leadership and guidance in review policy procedures, with particular emphasis on clinical testing and evaluation.
Provide an authoritative analysis of scientific data submitted to the Agency; and to develop new and innovative approaches to scientific testing as required for regulation of medical device throughout the total product lifecycle by FDA.
Serve as the OCEA focal point and primary contact for medical device clinical issues and provides expert and authoritative advice, guidance, assistance, interpretations, consultations and recommendations to top level and senior Agency and Departmental officials, program directors, scientific and professional personnel, industry, representatives, intra/inter-governmental counterparts, and others concerning medical device policies, programs, and activities.
Lead in the planning and development of OCEA’s clinical policy initiatives and makes decisions and/or recommendations that have major impacts on the Office’s clinical activities in its broad mission of protecting the Nation’s public health.
Professional Experience/Key Requirements:
To qualify for this position, you must demonstrate in your resume the necessary qualifying experience for this position, which is equivalent to the following:
Clinical and medical expertise related to clinical trial conduct, protection of human subjects, registry infrastructure development, and execution of safety studies.
Advising, training, and guiding a multi-disciplinary staff responsible for medical, clinical, public health and/or regulatory activities associated with medical products (i.e., devices, biologicals, drugs, etc.).
Expert in interpreting and presenting complex scientific, medical, clinical, and regulatory information and concepts, in both written and oral formats for a variety of audiences.
Clinical and medical expertise on medical devices; professional knowledge and understanding of current FDA regulations, policies, and procedures pertaining to safe and effective medical devices.
Ability to build collaborative and mutually beneficial working relationships with a diverse cadre of customers and stakeholders.
Physician, GP-0602: Must be a U.S. citizen with Doctor of Medicine (M.D.), Doctor of Osteopathic Medicine (D.O.) or equivalent from a school in the United States or Canada. The degree must have been approved by a recognized accrediting body at the time the degree was obtained.
A Doctor of Medicine or equivalent degree from a foreign medical school that provided education and medical knowledge substantially equivalent to accredited schools in the United States may be demonstrated by the Educational Commission for Foreign Medical Graduates, or a fifth pathway certificate for Americans who completed premedical education in the United States and graduate education in a foreign country. Candidates for Civil Service or U.S. Commissioned Corps must possess a valid license to practice medicine in any state in the U.S. It is highly desired that the prospective candidate has eligible Board Certification.
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.
This position is subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for the employee, the spouse, and minor children of the employee. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office website athttps://www.fda.gov/about-fda/jobs-and-training-fda/ethics.
How to Apply:
Prior to applying, please see the following instructions:
Documents to submit: electronic resume or curriculum vitae, cover letter describing why you are uniquely qualified for this, and copy of transcripts
Compile all applicant documents into one combined document (i.e., Adobe PDF)
Include Job Reference code “2020-OCEA-IO-017” in the email subject line.
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.
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.
A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits.
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.
You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis.
About FDA Center for Devices And Radiological Health (CDRH)
The world renowned U.S. Food and Drug Administration (FDA), is a government agency that is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The Center for Devices and Radiological Health (CDRH), part of the U.S. Food and Drug Administration (FDA), assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S. FDA is an equal opportunity employer and encourages applications from a diverse pool of high quality candidates. FDA offers its employees a wide array of benefits.If you are interested in leading the way in medical excellence, please click on the links to apply to the positions.