Director/Sr Director, Reading Center

Lexitas

14d

About The Position

The Director/Sr Director of the Reading Center has oversight and accountability for the strategic, operational and financial management of the Lexitas Reading Center. They will be customer facing and support BD in all customer interactions in which the reading center is of interest. They will support new opportunities, proposals and bid defenses to increase awareness of this offering within the marketplace. They will work closely with the reading center technology partner to support continued evolution and optimize any cross functional collaboration ensuring adequate resource allocation. They will be responsible and accountable for internal reading center activities including but not limited to hiring and managing reader/graders, data quality management (review and adjudication process) and participating in the study-specific reading/grading process. They will be responsible for ensuring data integrity and managing the CAPA process.

Requirements

Education: Bachelor's Degree or Higher
Experience: A Minimum of 5+ years of experience in the pharmaceutical/CRO industry and at least 3 years operational experience within a reading center. Experience in ophthalmology is preferred.
Skills:
Comprehensive understanding of scientific affairs and concerns in all stages of drug development
A successful history of cross-functional collaboration
Sound knowledge of all relevant regulations and guidelines
Excellent verbal and written communication skills. Excellent presentation skills
Good planning and organizational skills with the ability to adapt and adjust to changing priorities
Ability to be productive and handle multiple tasks to meet deadlines in a dynamic, fast-paced environment

Nice To Haves

Provides tactical support in reading/grading process and oversight as needed and as previous training and experience allows (not required but strongly preferred)
Experience in ophthalmology is preferred.

Responsibilities

Oversees the setting and optimization of Policies, Standard Operating Procedures, Work Instructions, and Study Specific Procedures in accordance with current GxP standards and applicable regulations (e.g., Good Clinical Practices, Good Documentation Practice, 21 CFR Part 11/Annex 11, MHRA, GDPR, HIPPA).
Directs daily Reading Center operations, including staffing, scheduling, training, and performance evaluations as required
Establishing and maintaining KPIs
Proactively track ongoing study progress and deliverables
Ensure projects are delivered on time and on budget
Develop mitigation plans as needed
Serve as a point of escalation for sponsors/clients
Proactively assess processes and procedures for efficiency
Collaborates with Clinical Operations, Quality Assurance and other departments to optimize delivery.Describe the specific responsibilities and job functions of the role
Collaborates with marketing and sales to increase awareness of the offering and support business growth.
Oversight and management of Vendors/service providers to the Reading Center
Provides tactical support in reading/grading process and oversight as needed and as previous training and experience allows (not required but strongly preferred)
Provides guidance to Lexitas stakeholders (internal and external) for future development trends.
Work with Finance team to track forecasting and revenue estimations and optimize resource allocation.
Develop and maintain relationships with institutions and individual physicians to grow the Reader pool.
Oversight and management of periodic reader documentation assessments
Develop and maintain Reader Management department KPI and metrics.
Provide reports on reviewer usage and costs.