Vice President, Technical - Clinical Regulatory Cell & Gene Therapy

Seeking a Cell and/or Gene Therapy SME to join Parexel Regulatory Consulting!

This is an amazing opportunity to work alongside of some of the Industry’s best, make significant contributions to our clients’ Cell and/or Gene Therapy development programs, help shape precedent, and, ultimately, help bring new treatment options to patients in need!

We currently have a home-based opening on our Regulatory Consulting Services Team for an Industry Thought Leader to join our team of experts as a Vice President, Technical with past experience driving the Clinical Regulatory strategies and development plans for Cell and/or Gene Therapy products.

A Technical Vice President must be an internationally recognized professional in their field of expertise with fully proven rainmaking skills and relationships at the most senior levels within client organizations. A Technical VP must have a thorough understanding of the organization’s consulting models and methodologies, as well as extensive knowledge of what services Parexel Consulting provides. A Technical VP provides a full range of consulting services and works within their personal area of expertise. A Technical VP provides mentoring and guidance to other PC employees and leads knowledge-centered activities within Parexel Consulting. A Technical VP participates in the development of new service offerings, consulting models and methodologies.

Project Execution Works within a team environment or individually based on the project needs Works within broad project guidelines and leads issue and conflict resolutions Prioritizes own workload and prioritizes the work load of the project team in order to achieve the project scope and objectives Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions Produces quality work that meets the expectations of Parexel Consulting and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and Parexel Consulting are met Manages project engagements (small or large) Interacts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project support Provides guidance to project team members and acts as a mentor to junior staff Thought Leadership Frequently presents speeches or seminars to industry groups. Often requested by name as a speaker based on recognized expertise in his/her field Frequently authors articles for publication in industry magazines, newsletters, book chapters and other forums Reviews the thought leadership activities (presentations, articles) of colleagues for content and quality to ensure the expectations of Parexel Consulting are met Regularly quoted by general and industry news outlets When applicable, serves as a leading member of industry association boards, task forces and committees and/ or as chairperson or officer of one or more professional associations Contributes expertise to professional societies, academic or other similar groups influential in his/ her area of expertise Reinforces the knowledge-centered activities within Parexel Consulting based on their own knowledge and expertise Facilitates improvements to the Parexel business processes Facilitates new service and consulting model development QualificationsConsulting Activities and Relationship Management Adapts the appropriate organization’s consulting models and methodologies when unique situations present themselves as well as designs//improves the methodologies when needed Provides a full range of technical and/or business consulting services across multiple disciplines of services including representing clients to regulatory agencies Completes and delegates project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfaction Acts as a trusted advisor to clients, often on issues that lack precedent or are not clearly defined Acts as a loaned executive for a client when required Facilitates resolutions to possible problems or conflicts within the project team and/or the client Provides guidance as needed to junior colleagues on appropriate methods of executing project activities Develops and implements business solutions addressing specific client needs using expertise, best practices and knowledge of the client’s business and key industry drivers Demonstrated ability to interact professionally at multiple levels including senior and executive management within a client organization. Presents to client boards and provide strategic advice to the C suite Plans and delivers services and solutions which results in clients expressing satisfaction with service provided and builds relationships which results in additional business or referrals Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with PC management and account management Requirements Minimum of an advanced degree in a scientific or technical discipline, MD preferred; however, PhD, PharmD, and other candidates with equivalent relevant experience will also be considered Pertinent professional certification such as R.Ph., RAC, CHCC, CQA, CQE, etc also desirable but not mandatory 15+ years experience in drug development with expert level industry experience or direct regulatory knowledge gained by directly working for a regulatory agency (such as FDA in OTAT, MHRA, etc) is required 5+ years Cell and/or Gene Therapy Industry related work is preferred; however, candidates with Fellowship or Graduate Research in these areas will also be considered Up to 30% international or domestic travel may be required in the future

EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.