Associate Medical Director

The Associate Medical Director, Clinical Development supports medical direction, management, and review of clinical trials and product development in advancing efforts to develop novel therapeutics for metabolic and endocrine disorders. Working under the guidance of senior medical leadership, this role contributes to clinical development program plans, clinical protocol development, medical monitoring of clinical trials, and analysis of study data and preparation of trial reports and related regulatory documents.

This individual will have a solid understanding of clinical drug development, with the opportunity to build expertise in late-phase clinical trials, translational science, and operational excellence while working closely with senior medical leadership.

Essential Duties and Responsibilities

The main responsibilities of this role include:

• Support protocol development for clinical studies in collaboration with Clinical Operations and other clinical sub-team functions, under the direction of senior medical leadership.
• Contribute to preparation of clinical development plans in partnership with cross-functional teams.
• Provide operational and scientific input to teams based on medical and clinical judgment, escalating complex medical or strategic questions to senior medical leadership.
• Support preparation and review of regulatory documents, including clinical scientific materials such as INDs, IND amendments, Investigator Brochures, DSURs, and other FDA/health authority submissions.
• Contribute to the preparation and finalization of CSRs.
• Contribute to the development of study documents such as CRFs and ICFs.
• Contribute to the development of study plans such as MMPs, SMPs, DMPs, PD plans, and risk management logs.
• Review adverse event (AE) and serious adverse event (SAE) reports, provide medical assessments of causality, and escalate issues that may warrant protocol deviations or unblinding for patient safety to senior medical leadership.
• Support delivery of protocol, therapeutic indication, and safety training during KOMs, investigator meetings, and to clinical site staff before and during trials.
• Monitor and review data in ongoing studies.
• Serve as a sponsor medical point of contact for trial-related medical questions, and support review of eligibility and, at times, dosing decisions.
• Provide CRO’S Medical Team Oversight
• Support communication among the sponsor, investigators, sites, and, at times, DSMBs, Clinical Event Committee (CECs) or other Safety Committees, ensuring clear communication of medical information and prompt escalation of issues to senior medical leadership.
• Support preparation of clinical study outcomes and other data for presentation at meetings, including but not limited to those with health authorities, academic conferences, and medical congresses.
• Support the development and maintenance of relationships with internal and external scientific experts to help advance the company's interests from a medical perspective.
• Provide subject matter input to team members and colleagues.
• Perform additional duties as assigned.