[Hiring] Medical Director @Sitero LLC

Role Description

The Medical Director will provide strategic input into current and potential clinical projects, support site investigators, and manage the medical monitoring in managing all medical aspects of clinical trials.

• Responsible for strategic input on potential projects that support proposal writing and bid-defense meetings.
• Deep understanding of the therapeutic area’s current clinical research landscape.
• Support of data review and medical writing for protocols and study-specific reports (regulatory annual reports, clinical study report (CSR)).
• Experience in FDA interactions, including all IND support (Pre-submission, Type A, B, and C, and IDE support, Pre-Sub, Informal and Submission meetings).
• Review and address site and CRA queries for inclusion/exclusion criteria.
• Prepare listings of protocol deviations and adverse events for regular meetings.
• Perform initial review for coding and reconcile coding based on inputs from clinical and medical teams.

Qualifications

• Licensed MD or PhD.
• 2 years of experience working in clinical trials as a medical monitoring associate or equivalent relevant experience.
• Experience in Gastroenterology and Hepatology.
• Metabolic trial experience (preferred).

Requirements

• Proven track record of strategy development for FDA submission.
• Protocol development.
• Medical writing support for protocol and study reports.
• Experience with FDA interactions.
• Prepare and review protocol deviation listing.
• Code protocol deviations per protocol deviation guidance.
• Prepare drafts of appropriate study plans.
• Prepare adverse event listings.
• Assist the medical monitoring in management of clinical trials.

Benefits

• Competitive salary.
• Variable pay.
• Paid time off.
• Healthcare benefits.
• Retirement benefits.

Company Description

Sitero is an emerging leader in clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths.