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Vice President, Technical - Regulatory, Nonclinical CGT (Home-based)

USA - Any Region - Home Based Date posted 08/03/2020 Job ID post-00024376

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.

  • Full Time
  • Level: Mid
  • Travel: Yes
  • Glassdoor Rating 3.5

Success Profile

Check out the top traits we're looking for and see if you have the right mix.

  • Detail-Oriented
  • Proactive
  • Problem-Solver
  • Results-Driven
  • Organized
  • Multi-Tasker
  • "They say if you are passionate about what you do, you will never work a day in your life. I can honestly say that this applies to me. I love what I do."

    Jasen - Consultant
  • "My experience so far with Parexel has been great! I had initially started at Parexel as an Independent Consultant but was then presented with a full time job opportunity to really become a part of this fascinating company. I have enjoyed the flexibility to be able to orchestrate a good work/life balance, as well as learn from so many experts in consulting arena and really have a hands-on role with every day bringing a new but exciting challenge."

    Aqip – Consultant
  • "I was offered an incredible opportunity to continue my career in regulatory affairs without relocating 1,000 miles away and making major life changes. Parexel is an innovative, growing company which offers much needed flexibility and opportunities for professional growth."

    Blaine – Consultant
  • "Parexel is a very large organization and holds a top position amongst the different companies engaged in the Consulting business. It can offer many opportunities for development and career progression. Also the diversity of projects can offer a great expansion of knowledge in many areas of the Regulatory Affairs arena. Last (but not least), Parexel offers a variety of rewards to the employees (bonus scheme, benefits etc)."

    Giannis – Consultant
  • "Parexel is a CRO that I had always inspired to join because of the variety of knowledge, experts, culture, flexibility and exposure to be client facing as well as to use my technical knowledge all under a professional and diligent environment. I believe it has provided me the right platform to grow both professionally and individually with the opportunities to present my views and to dialogue with colleagues and clients with all but positive outcomes."

    Aqip – Consultant


  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Management

    Strong management with depth of experience working for global health authorities.


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


Consulting 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 Disclaimer

PAREXEL 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.

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