Vice President, Technical - Regulatory, Nonclinical CGT or Biologics

Parexel International Corporation

USA - Any Region - Home Based

Seeking experienced Nonclinical Cell and Gene Therapy or Nonclinical Biologics SMEs* who are passionate about drug development and committed to making a difference to join Parexel’s highly recognized Regulatory Consulting Team!

Are you dedicated to Public Health? Committed to making a difference? But you feel like you’ve hit a ceiling professionally and you’re unsure of the next step in your career… Well, Parexel Consulting is growing and we're seeking experienced Regulatory professionals just like you, who are passionate about drug development and who are looking for opportunities to stretch your thinking, advance professionally, and present/execute solutions for our clients.

Parexel’s Consulting team is known for our unparalleled breadth and depth of expertise globally. Parexel Consulting overcomes the obstacles to get products to market faster and smarter. Our scientific, regulatory, and operational expertise puts best practice standards to work for clients large and small, designing solutions for a constantly evolving healthcare landscape.

We currently have a home-based opening for an Industry Thought Leader to join Parexel’s Consulting Team of experts as a Vice President, Technical (Nonclinical CGT or Nonclinical Biologics).

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 PC 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 PC. 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 workload of the project team 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 PC and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC 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 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 PC 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 PC 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 lower level 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


Minimum of an advanced degree in a scientific or technical discipline or MBA, PhD preferred, or equivalent experience

Pertinent professional certification such as R.Ph., RAC, CHCC, CQA, CQE, DABT, etc also desirable but not mandatory

Numerous years experience with expert level industry or regulatory knowledge experience with a regulatory agency (such as FDA, MHRA) is highly preferred

Familiarity with unique requirements for nonclinical development of CGT products; however, training in traditional nonclinical study design for small and/or large molecules is preferred

Previous experience supporting or reviewing IND submissions for gene modified cells, AAV products, or gene editing products is required

Previous experience with assessment of nonclinical study design is a plus

*Consideration will be giving to Nonclinical Biologics SMEs who are passionate about expanding their expertise to CGT

Now is the time to join this DYNAMIC Team and work alongside like-minded colleagues with a wealth of Industry and FDA experience, along with a wide variety of Technical Expertise!

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.

2020-11-07 01:00:32

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