Senior Director, Global Clinical Network

Job Description

Job Description

SUMMARY

This position is responsible for managing the clinical collection network and support the short- and long-term revenue delivery for Disease State business unit.

Areas of responsibility include feasibility, site management, and the network development departments. This position will partner with internal teams, such as commercial, customer experience, project management, and lab operations to support order fulfillment and manage clinical supply inventory.

As a member of the Disease State business unit’s senior leadership, the person in this position is responsible for developing strategy, leading the clinical network team and driving the business to success.

The Director will act as partner to all departments in BioIVT’s operation and functional departments. Responsibilities include assessing, managing, and leading large scope projects and rebuilding feasibility models and project plans for delivery.

This role requires close and accurate tracking of progress against established timelines and goals; distribution of this information to all stakeholders;

escalation of concerns if project deadlines become at risk. The Director will also be responsible for business analysis of existing clinical sites.

The individual in this role must have the ability to manage multiple projects and functions at any given time with customer satisfaction being of primary focus.

A key function is to establish and maintain excellent working relationships with business development, commercial operations, laboratory operations and supply team members.

In addition, BioIVT sets high standards in ethics; the Director must ensure compliance through a broad network and comply with many complex and varying governments and government regulations throughout the world.

This position will ensure compliance with Environmental Health and Safety (EHS) policies, State Departments of Health, Good Documentation Practices (GDP), Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practice (GLP), Standard Operating Procedures (SOPs), EMEA and FDA Guidelines, general State and Country Regulations such as but not limited to (CLIA, CAP, USP, ISO 9001, USDA regulations, HTA license, DEA and State Controlled Substance programs) where site appropriate.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Builds an environment of teamwork, innovation, personal responsibility and communication with all colleagues through an effective process that utilizes feedback, suggestions, and participation to improve processes.
• Optimize processes, develop employees and implement tools to drive the performance of the collection network organization.
• Provides strategic thinking and direction in collaboration with colleagues to develop and lead the global clinical network and biospecimen clinical collections.

Provides the tactical abilities to implement leading clinical network practices.

• Develop, establish and monitor KPI to ensure superior performance of the clinical network.
• May lead and / or facilitate team strategy initiatives.
• Responsible for all aspects of performance including accruals, sample quality, and regulatory performance.
• Leads efforts to improve collection sites performance.
• Lead network development, feasibility and operations to ensure supply region meets the current and future needs of the business.
• Coach and manage supply sites to meet top performance standards, recommend suppliers for retraining as needed
• Identify areas for operations improvements at the site and internally, pursue continuous improvement objectives
• Other duties as assigned

TELECOMMUTING REQUIREMENTS :

While telecommuting, the employee is required to have a designated, in-home workspace and reliable internet connection.

TRAVEL

This position may require up to 40% travel over the course of a year.

QUALIFICATIONS :

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required.

Education and / or Experience

• Bachelor's degree in science or related field, or equivalent work experience.
• Experience in healthcare, clinical trials, medical devices, biotechnology, or pharmaceutical industry
• Experience managing complex projects in a high-tech environment. Clinical trials management experience preferred
• Experience leading teams responsible for clinical biospecimen supply management
• Knowledge of government structure, regulatory requirements and ethical regulations pertaining to purchasing human tissue in countries located in North, Central and South America, Europe, or Asia
• Familiarity with scientific terminology
• Proven track record of negotiating contracts
• Experience managing project budgets and tracking expenditures
• Strong relationship building and managing experience (customer service or sales)
• Demonstrated ability to influence decisions of key stakeholders
• Previous experience developing direct reports and others preferred

Certificates, Licenses, Registrations Required

None required.

Other Skills and Abilities

• Outstanding organizational skills, including ability to handle multiple assignments concurrently
• Able to work accurately, consistently and efficiently on assigned projects, superior prioritization skills
• Independent problem-solving and decision-making abilities
• Ability to coach and mentor team members
• Strong interpersonal skills including ability to communicate effectively and influence others
• Ability to work effectively both independently and as part of a team
• Strong computer skills, (knowledge of Microsoft Office, Word, Excel, and PowerPoint)

PHYSICAL DEMANDS :

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions .

Typical office environment. While performing the duties of this job, the employee may be required to : stand; walk, sit, stoop, kneel, crouch, crawl, speak, hear / listen, , display manual dexterity, reach with hand and arms.

Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT :

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Administrative While performing the duties of this job, the employee will be working in professional office environment using standard office equipment.

A full-time Monday through Friday workweek with general business hours.

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position.

To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.

Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws.

All job requirements are subject to modification to reasonably accommodate individuals with disabilities. Continued employment remains on an at-will basis, unless otherwise contractually bound.