Medical Director (Contract)
Core
Provide strategic medical leadership for endocrinology clinical trial projects, supporting study design, regulatory activities, and data review.
Role type
Contract Medical Director (Endocrinology)
Builds
Clinical trial protocols, regulatory submissions, and safety/compliance reports for early-phase through Phase III development.
Domain
Clinical research / Endocrinology
Deliverable
client delivery
Required skills
Endocrinology expertise, Clinical trial strategy, FDA regulatory interactions, Protocol development, Medical writing, Medical monitoring, Adverse event management, Data review
Preferred skills
Pediatrics experience, Metabolic trial experience
Technologies
Clinical Trial Management Systems (CTMS), Excel
Responsibilities
Provide strategic medical input for proposal development and bid-defense meetings; Contribute to protocol development, study plans, and clinical study reports; Support FDA interactions including IND pre-submission and Type A/B/C meetings; Support medical monitoring and management of clinical trial medical aspects; Review site/CRA questions on inclusion/exclusion criteria; Prepare and review protocol deviation listings; Prepare adverse event listings and support coding review; Contribute to data review and study-specific medical assessments.
