Medical Director (Contract)

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Medical Director (Contract) based in the United States.

This part-time, contract opportunity is designed for a physician or PhD-level professional with expertise in endocrinology and clinical research. The Medical Director will provide strategic medical leadership across clinical trial projects, supporting study design, medical monitoring, regulatory activities, and data review. The role offers exposure to projects spanning early-phase through Phase III clinical development. You’ll contribute to protocol development, medical writing, FDA interactions, and the management of key safety and compliance activities. Working remotely and on an hourly, project-based schedule, you’ll collaborate with clinical and medical teams while operating with a high degree of independence. The position is well suited to an experienced clinical research professional who can provide strong therapeutic and regulatory expertise when projects require it.

• Provide strategic medical input into current and potential clinical projects, including proposal development and bid-defense meetings.
• Apply in-depth knowledge of the endocrinology clinical research landscape to support study strategy and development.
• Contribute to protocol development, study plans, regulatory annual reports, clinical study reports, and other medical writing activities.
• Support FDA interactions and regulatory activities, including IND-related pre-submission and Type A, B, and C meetings, as well as IDE support and Pre-Sub, informal, and submission meetings.
• Support medical monitoring and the management of medical aspects of clinical trials.
• Review and address site and CRA questions related to inclusion and exclusion criteria.
• Prepare and review protocol deviation listings and code deviations according to applicable protocol deviation guidance.
• Prepare adverse event listings and support initial coding review and reconciliation with clinical and medical team input.
• Contribute to data review and study-specific medical assessments to support clinical trial quality, safety, and compliance.

Requirements:

• Licensed MD or PhD with a background in endocrinology or a related field.
• At least 2 years of clinical trial experience as a medical monitoring associate or in an equivalent relevant role.
• Demonstrated experience supporting clinical trial strategy and FDA submission activities.
• Experience with protocol development and medical writing for protocols and clinical study reports.
• Strong understanding of FDA interactions and clinical regulatory processes.
• Endocrinology expertise required; pediatrics and metabolic trial experience are preferred.
• Strong written and verbal communication skills, with the ability to collaborate effectively across clinical and medical teams.
• Ability to work independently, manage priorities, and provide reliable support in a project-based environment.
• Working knowledge of Excel and Clinical Trial Management Systems (CTMS).

Benefits:

• Competitive compensation with variable pay opportunities.
• Paid time off.
• Healthcare benefits.
• Retirement benefits.
• Part-time, hourly contract employment.
• Remote work within the United States.
• Flexible, project-based hours according to clinical trial requirements.
• Opportunity to work shifts as needed based on project demands.