Medical Director (Contract)

Accountabilities: • 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.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether?

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