We’re looking for purpose-driven, passionate individuals to join our team. From clinical to commercial to supporting functions, Lexitans believe in the common mission: to be the best ophthalmic product development organization to partner with. 

Overview

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.

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.

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

Physical Requirements

Position requires: ordinary ambulatory skills and physical coordination sufficient to move about conference or meeting locations as required; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. Lexitas Pharma Services, Inc., at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Lexitas Pharma Services, Inc., at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.