Medical Director

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. The Medical Director is responsible for strategic input on potential projects that support proposal writing and bid-defense meetings including a deep understanding of 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)). Has experience in FDA interactions examples, all IND support (Pre-submission, Type A, B and C, and IDE support, Pre-Sub, Informal and Submission meetings). The Medical Director will also be responsible for review and addressing site and CRA queries for inclusion/exclusion criteria. The Medical Director will be responsible for preparing listings of protocol deviations and adverse events for regular meetings, performing initial review for coding and reconciling coding based on the inputs of the clinical and medical teams.

Essential Duties and Responsibilities

• 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
• Auxiliary medical writing support
• Assist the medical monitoring in management of clinical trials

Education and Experience Required

• Licensed MD or PhD
• 2 years of experience working in clinical trials as a medical monitoring associate or equivalent relevant experience
• Endocrinology
• Pediatrics (preferred)
• Metabolic trial experience (preferred)

PREFERRED SKILLS

• Strong communication
• Medical Writing
• Independent worker
• Excel
• CTMS

Compensation & Benefits

Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.

Employment Type

Contract; Part time, Hourly

Commitments

Hourly as project requires
Willing to work in shifts as and when needed.