Job Description

The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD, and be willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.

A Day in the Life:

As an expert for the FDA, you will review new drugs to ensure that theyre safe and effective.

• Before testing on humans: You will check if the drugs design is sound and backed by strong animal testing.
• For approval: You will evaluate clinical trial results and labeling accuracy to ensure the drug works as intended and has clear instructions and warnings.
• For existing drugs: You will review updates, safety reports, and potential new uses or label changes.

You will work with your team to make evidence-based decisions.

• You will analyze summaries from other experts and recommend approving, requesting more data, or rejecting applications.
• You will consult with other specialists to address complex issues and stay up to date on scientific advancements.
• You will share your expertise through conferences and publications.

Position Requirements:

Education:

• US or Canadian Medical Degree: MD, DO, or equivalent from an accredited school.
• Foreign Medical Degree: MD or equivalency, such as a ECFMG certification or USMLE completion.

Licensure:

• Current, active, full, and unrestricted medical license in the US or its territories.

Needed Experience:

• Ability to apply clinical and scientific knowledge to complex medical problems and benefit/risk management.
• Enjoys solving unique problems and addressing challenges in drug/biologic regulatory review.
• Desire to stay current on the latest clinical information in your assigned therapeutic area.
• Capable of strong written and verbal communication.

The Division of Anesthesiology, Addiction Medicine, and Pain Medicine regulates and reviews Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologics Licensing Applications (BLAs) for prescription drugs and biologics intended for the prevention, treatment, or diagnosis of conditions including:

• Acute Pain, e.g.:
  • Surgical and procedural pain
  • Pain due to trauma/injury
  • Pain due to acute inflammatory processes

• Chronic pain, e.g.:
  • Cancer pain
  • Neuropathic pain
  • Fibromyalgia
  • Osteoarthritis Pain
  • Low back pain

• Addiction, e.g.:
  • Nicotine
  • Alcohol
  • Stimulants
  • Opioids

DAAP also regulates the drug product classes that are used in surgical, procedural or ICU settings to provide patient comfort and/or ease of treatment, e.g.:

• General anesthetics
• Local anesthetics
• Dental anesthetics
• Topical anesthetics
• Neuromuscular-blocking agents and neuromuscular-blocker reversal agents

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