Senior Director, Regulatory Affairs (R1062649) in Durham, NC at IQVIA™

Date Posted: 6/28/2019

Job Snapshot

  • Employee Type:
  • Location:
    Durham, NC
  • Experience:
    Not Specified
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Job Description

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.

Serve as a therapeutic and/or operational expert throughout the new business and program/project delivery lifecycle.


 Accountable and responsible for creating effective delivery strategies and solutions for large, complex, multi-service, multi-region studies or programs to include mega studies and portfolio management, addressing the specific needs and challenges of each customer and differentiate Quintiles from its competitors. In partnership with Sales, Medical, Operations, and other functions, responsible for award of strategic and tactical new business to achieve annual Gross New Business targets.

 Act as champion for project centricity within the organization through enabling the project delivery team assigned to an awarded project to understand and implement the project strategy that was sold. Evaluate and recommend effective adjustments to strategy when any trends or triggers associated with progress indicate this is required.

 Actively support long term enterprise business growth through collaboration with Centers of Excellence and other stakeholders.

 Accountable for the creation and optimization of innovative and effective and compelling delivery strategies and solutions for large, complex, multi-service, multi-region studies or programs, including mega studies and portfolio management, that incorporate and leverage services and experience, are operationally feasible, and result in the award of new business.

 Collaborate with Sales to evaluate and manage new opportunities received from customers from receipt through to award decision. This may include, but is not limited to, stand-alone programs and projects, requests for information (RFI), capabilities, early engagement, and partnering discussions.

 Work with key internal stakeholders to analyze information and data that enables development of efficient and feasible delivery solutions. This may include, but is not limited to, protocol feasibility and risk management, identification of target site and principal investigator profiles, optimal country and site distributions, site initiation and patient recruitment modelling, assessment and management of the competitive landscape.

 Development and review of the budget (labor and pass-through costs) associated with the proposed project strategy. The budget should be competitive and in line with the contribution margin targets and pricing strategy agreed with Sales, leadership, and other stakeholders.

 Support internal review and approval of both the opportunity approach and strategy before proposals are issued to customers including presentations to senior leadership.

 Define and communicate the project team profile and organizational structure that will enable operational managers to identify and assign team members that can meet the customer’s needs and successfully secure the project award.

 Guide and mentor assigned Project Leader through a comprehensive handover of the project strategy and facilitate their understanding so that they can confidently present the project strategy to the client and the internal stakeholders.

 Actively support Sales in the preparation and conduct of customer and bid defense meetings, e.g. training and preparation of the assigned project team; provide specific content; ensure presentation focus and content effectively conveys project strategy and critical win themes. Attend and present at customer meeting, or bid defense or partnership meetings, as required, (based on the strategy for selling the opportunity).

 Coordinate with Sales to complete follow up actions identified at bid defenses and customer/ partnership meetings.

 During project execution, evaluate the project strategy with the project team and adjust delivery strategy when project or program progress, trends, and milestones indicate intervention required.

 Lead and support development of a project delivery strategy and budget over a short or potentially extended period as part of an early engagement effort. This may be in support of a customer partnership model where new work is assigned to IQVIA in advance and/or non-competitively. It may also be used to develop a relationship and win business from a customer where Quintiles seeks to proactively establish a relationship and win new business.


 Bachelor's degree in life sciences, advanced degree preferred, with specialization in one or more therapeutic areas and 15 years global clinical research relevant experience, including hands on operational delivery and/or drug development experience; or equivalent combination of education, training and experience

 Proven track record in operational delivery and/or drug development

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™

Job ID: R1062649