IQVIA Vice President/Senior Director, Medical Device & Diagnostics (Home/Office-based) - Novella Clinical in Morrisville, North Carolina

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Bring your Medical Device expertise and clinical research acumen to Novella Clinical. We are looking for a proven leader to help us deliver the industry leading Clinical solution to medical device and diagnostics companies. Your technical depth and regulatory skills will allow you to participate in our med-tech growth strategy. We are part of Research & Development Solutions within IQVIA, which means our clients benefit from our high-touch approach to project management and access to the data and infrastructure from IQVIA CORE services.

If you have the ability to think critically and creatively, you can capitalize on your knowledge and your network as the VP, Medical Device & Diagnostics , and help us empower our teams to approach the delivery of clinical research services differently. In this role you will assume global accountability for successful project and program delivery across our device and diagnostics portfolio of clinical trials. We need proven leaders who can develop and implement strategic plans, set strategic goals, and partner with key stakeholders to provide high quality, client-oriented services and drive teams to achieve our standards of excellence.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Influence and shape the direction of the Medical Device & Diagnostics Division including recommendations regarding market, policy and practice

  • Direct the operations of the Medical Device & Diagnostics Division, assuring project deliverables are achieved for each device & diagnostics clinical study

  • Participate in business development activities as required to support divisional growth

  • Develop relationships with key customer accounts, specifically therapeutic decision-makers, and engage through regular customer meetings for key accounts; providing executive oversight for designated client programs

  • Participate as a member of Novella Clinical’s executive management team

  • Manage divisional staff in accordance with company policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems

  • Lead and develop divisional personnel to assure the development of staff along career progression goals and strategic divisional and corporate priorities

  • Formulate effective strategic goals for the Medical Device & Diagnostics Division and take ownership for strategic initiatives, including development of measures for success

  • Provide strategic leadership and input for the resourcing process and continually review and ensure adequate resources are available to meet deliverables and milestones

  • Evaluate the quality of the work product, together with the workload, quality and budget metrics through regular analysis of data; initiate action plans to improve efficiencies, project outcomes and quality metrics for processes and roles

  • Ensure projected net revenue and contribution margins, overhead costs and operating surplus for projects are met; play a leadership role in the budget development process and in the development of key fiscal outcome metrics; monitor the execution of the budget via thorough analysis of ongoing outputs; proactively develop forecasts and risk assessment in alignment with budgetary goals; institute fiscal action plans when necessary

  • Provide executive leadership for project teams when necessary to manage project related challenges and to achieve exemplary customer service

  • Drive quality or process improvement initiatives related to corporate or departmental strategic plans

  • Ensure adherence to Novella’s quality policy and assure compliance with SOPs and defined divisional metrics, including the administration of Corrective and Preventative Action plans

  • Participate in function and/or corporate initiatives, special project assignments, and as a client liaison or departmental cross-functional liaison

  • In-depth technical and product expertise and knowledge of the clinical research process from feasibility through regulatory submission

  • Expert knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

  • Established relationships with a network of key opinion leaders across Medical Device & Diagnostics

  • Demonstrated track record in successfully co-designing and leading trials in Medical Device & Diagnostics

  • Demonstrated knowledge of electronic data management and clinical operations

  • Demonstrated knowledge of quality assurance related to clinical trial implementation

  • Demonstrated ability to form strong working relationships across functional boundaries

  • Demonstrated knowledge of financial management, project financial tracking and accounting methods and skill in applying them

  • Excellent communication and interpersonal skills, including strong command of English language and superior presentation skills

  • Excellent organization and problem-solving skills

  • Strong influencing and negotiation skills

  • Proven ability to work with others in a global environment to deliver results to the appropriate quality and timeline metrics

  • Highly effective team leadership skills

  • Excellent customer service skills

  • Sound judgment and decision-making skills

  • Ability to balance operational and strategic priorities

  • Strong software and computer skills, including MS Office application

  • Ability to establish and maintain effective working relationships with coworkers, managers and clients

KNOWLEDGE, SKILLS AND ABILITIES:

  • In-depth medical device and diagnostics technical and product expertise and knowledge of the clinical research process from feasibility through regulatory submission

  • Expert knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

  • Established relationships with a network of key opinion leaders across Medical Device & Diagnostics

  • Demonstrated track record in successfully co-designing and leading trials in Medical Device & Diagnostics

  • Demonstrated knowledge of electronic data management and clinical operations

  • Demonstrated knowledge of quality assurance related to clinical trial implementation

  • Demonstrated ability to form strong working relationships across functional boundaries

  • Demonstrated knowledge of financial management, project financial tracking and accounting methods and skill in applying them

  • Excellent communication and interpersonal skills, including strong command of English language and superior presentation skills

  • Excellent organization and problem-solving skills

  • Strong influencing and negotiation skills

  • Proven ability to work with others in a global environment to deliver results to the appropriate quality and timeline metrics

  • Highly effective team leadership skills

  • Excellent customer service skills

  • Sound judgment and decision-making skills

  • Ability to balance operational and strategic priorities

  • Strong software and computer skills, including MS Office application

  • Ability to establish and maintain effective working relationships with coworkers, managers and clients

University Degree (US Bachelor Level or equivalent) in a life sciences or health-related field and 17 years of clinical research experience including 9 years of leadership experience including a multi-regional and global focus, or equivalent combination of education, training and experience.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled'

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™

At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.

Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.