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Vice President, Technical - Nonclinical Regulatory SME

United States of America, Remote 求人ID R0000026061 Category Regulatory / Consulting
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About this Role

If you’re looking for the opportunity to influence the development strategies of pace-setting biopharma companies, there’s no better place to be than as a Vice President, Technical on Parexel’s Regulatory Consulting team!  As a VP, Tech you’ll work on a variety of assignments, diverse product types, in an array of therapeutic areas for clients with wide-ranging geographical considerations while enjoying fantastic career opportunities and work/life balance all while working from home.

With Parexel Regulatory Consulting, you’ll be creating opportunity for clients throughout the product lifecycle. Sharing your scientific, technical, regulatory and/or commercial expertise with them, so that they can bring better, safer products to market, in line with regulators’ requirements.

You’ll be meeting new situations and learning all the time. In fact, one of the key characteristics you’ll see in our VP Techs is innate curiosity along with a passion for the science, the industry, and public health.

You’ll be working at a senior / strategic level, and leading teams of respected SMEs in supplying the answers.  And, if you’re not already, you’ll soon certainly become a visible figure in the industry.

If you’re committed to public health, passionate about drug development, and want to make a difference, this is the ideal role.

A VP Tech requires an individual with extensive experience in non-clinical drug development, toxicology, and pharmacology, as well as a deep understanding of regulatory processes. The consultant is expected to provide expert-level advice and solutions to clients, often addressing complex and unprecedented issues. They must be able to adapt and develop consulting methodologies to meet unique client needs, while also contributing to the improvement of the organization's business processes.

A key aspect of this role is thought leadership, where the consultant is expected to provide innovative insights and perspectives that advance client development programs and position the organization as an industry leader. This includes presenting at industry events, authoring articles, and contributing to professional societies. The consultant's expertise should be widely recognized, often resulting in them being requested by name for speaking engagements.

Business development is another crucial component of the position. The consultant is expected to leverage their network and reputation to generate new business opportunities, participate in project scoping, and contribute to proposal preparation. Their personal brand and history of client satisfaction should drive repeat business and new client acquisition.

Knowledge and Experience:

  • The ideal candidate for this role will have at least 15+ years of experience in regulatory drug development, with expert-level industry knowledge.

  • Experience with regulatory agencies such as the FDA or MHRA is considered advantageous.

  • The consultant should have demonstrated expertise in non-clinical development of small molecules and biologics, with experience in cell and gene therapies (CGTs/ATMPs) as an added plus.

Education:

The position requires an advanced degree in a scientific or technical discipline, with a PhD or Master's degree preferred.

EEO Disclaimer

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

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