CASE STUDY

VP REGULATORY HAS WORLDWIDE RESPONSIBILITIES

The Client Opportunity                            

A public biopharmaceutical company in New York City, specializing in orphan drugs, was looking to advance their therapies through a fast-track model in order to begin phase III trials by mid-2017. With this ambitious program, they needed help in hiring a Vice President of Worldwide Regulatory Affairs to help drive this process and manage the regulatory activities, culminating with successful filings with the FDA and EMA. They had regulatory consultants managing the work, but as the programs gained momentum, they realized they needed someone to manage the process and take the lead full-time, so they retained the expertise of Ashton Tweed.

 

The Ashton Tweed Solution                                              

This Vice President of Worldwide Regulatory Affairs needed orphan disease experience, global experience, and Phase I – III program experience. The client also required a track record of significant and documentable accomplishments in regulatory affairs worldwide, the ability to travel to London where the European headquarters is located, as well as be on-site in New York City on a daily basis.

Image of stethoscope wrapped around the world - worldwide health conceptAshton Tweed embarked on this narrow search, communicating with both the office in NYC and the HQ in London. The Ashton Tweed team was skilled in navigating between what the NYC office and the London office needed and searched for top quality candidates to meet the needs of both the US and EU.

Ashton Tweed researched and contacted 226 candidates for this search. While NYC is a great hub for business, there was some resistance from candidates regarding the requirement to be on-site every day, because of the often tough commute into the city. However, with a small, growing company, the need for face-to-face time was imperative to help institute the culture and build a strong team. Although this made the search increasingly challenging, Ashton Tweed was able to narrow the field of candidates based on qualifications, interest, and fit for the client company. After final screenings, four top candidates were presented to the client for review.

The client hired their top choice, who had a PhD, MBA, and extensive biologics and orphan disease experience. Additionally, this candidate had global experience and a track record of success in both US and EU filings, had led international approvals for 6 significant biologics and small molecules, and had over 25 years of industry experience. Lastly, this candidate was local and had no problem with international travel to London or the commute into NYC.

 

The Benefits                                             

The company is now slated to begin three phase II trials in 2016, and expects to begin phase III trials by mid-2017 as planned. This high level role was filled in just 3 months, despite having to deal with end of the year holiday scheduling and coordinating across time zones for both the NYC and London office. The client has greatly appreciated Ashton tweed’s guidance on various issues throughout the process. Additionally, the Ashton Tweed team worked extensively with this company to help them negotiate a competitive compensation structure for this role, which included a base salary, bonus, and equity.

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