Director, Clinical Research

University of Miami•Miami, FL

3d•Onsite

About The Position

The Director, Clinical Research provides oversight, leadership, strategic insight, direction and implementation throughout the lifecycle of a clinical trial or research study. The Director also oversees strategic planning and the development of organizational goals and objectives.

Requirements

Master’s degree in relevant field
Minimum 7 years of relevant experience
Knowledge of business and management principles.
Ability to direct, manage, implement, and evaluate department operations.
Ability to establish department goals, and objectives that support the strategic plan.
Ability to effectively plan, delegate and/or supervise the work of others.
Ability to lead, motivate, develop, and train others.

Responsibilities

Develops and implements a service-oriented approach to assist investigators and research team members with tasks associated with study implementation.
Ensures compliance with all applicable regulatory standards related to clinical trials and interactions with Investigators and study teams.
Designs training in reference to regulatory guidance in order to promote increased understanding and future compliance.
Identifies and interacts with internal and external collaborators/consultants and key opinion leaders.
Collaborates cross-functionally with Clinical Operations, Regulatory Affairs, and Project Management areas and appropriately utilizes external vendors (e.g., CRO, consultants, etc.) to ensure study objectives/timelines are met, and activities are conducted in accordance with applicable regulations.
Reviews clinical data from all phases of development and assists in generating study reports and publications.
Interacts with domestic and foreign regulatory agencies.
Oversees and reviews regulatory submissions to domestic and foreign regulatory agencies.
Oversees the preparation, submission, and management of initial applications for Investigational New Drugs (IND) and Investigational Device Exemptions (IDE) to the FDA in collaboration with the Investigator and other Program team members.
Delivers clinical development timelines, enabling key decision points and Go/No Go criteria for the Clinical Program Development of an IND/IDE.
Assures appropriate regulatory, QA (Quality Assurance) and monitoring (clinical and medical) activities and personnel are available for UM held IND / IDE studies.
Oversees review of protocols for feasibility and ability to accomplish research objectives.
Serves as content expert for protocols that are being submitted with an IND / IDE.
Analyzes data and information throughout the life cycle of an IND/IDE, to determine course of events and corrective actions required in the event of major deviations.
Independently modifies SOPs, processes and policies in order to maintain future compliance and prevent reoccurrence of major deviations from the protocol and regulations.
Coordinates pre-clinical, clinical and chemistry, manufacturing and control team members in order to acquire necessary data to compile essential sponsor documents such as Investigator Brochures.
Oversees the preparation of briefing packages and leads/participates in the exchange of information during meetings with FDA.
Serves as the FDA’s primary point of contact for INDs and IDEs held by the University of Miami.
Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with university policies and procedures.
Ensures employees are trained on controls within the function and on university policy and procedures.