Senior Director, Global Clinical Network

BioIVT is a leading global provider of research models and value-added research services for drug discovery and development. We specialize in control and disease-state biospecimens, including human and animal tissues, cell products, blood and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research, aiming to improve patient outcomes by coupling comprehensive clinical data with donor samples. As the premier supplier of hepatic products, including hepatocytes and subcellular fractions, BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly discovered compounds and their effects on disease processes. By combining our technical expertise, exceptional customer service and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in elevating science.

SUMMARY

This position is responsible for managing the clinical collection network and supporting the short- and long-term revenue delivery for the Disease State business unit. Areas of responsibility include feasibility, site management, and 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 Senior Director will act as a 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 Senior 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 Senior 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), Standard Operating Procedures (SOPs), EMEA and FDA Guidelines, and 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 KPIs 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 the ability to handle multiple assignments concurrently.
• Able to work accurately, consistently, and efficiently on assigned projects, with superior prioritization skills.
• Independent problem-solving and decision-making abilities.
• Ability to coach and mentor team members.
• Strong interpersonal skills including the 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).

Other duties may be assigned.

We offer a comprehensive benefit package for eligible team members, including medical, dental, vision, short-term/long-term disability, life insurance, hospital indemnity and accident insurance. We also provide a generous retirement plan with a company match. Eligible employees enjoy competitive time-off policies and a collaborative environment that promotes growth from within. Enjoy company-sponsored events for the entire team!

Join Us!

We can’t wait to work with you! At BioIVT, we believe that diversity and inclusion are key drivers of innovation and success. We are committed to creating a workplace where everyone feels valued, respected, and empowered to bring their unique perspectives to the table. We seek to build a diverse team and encourage applications from people of all backgrounds, experiences, and identities.

To learn more about our mission and team culture, click here!