Project Director, Global Drug Approval

Parsippany, New Jersey

How many opportunities exist for you to work on something truly ground breaking?

Talent Orchard LLC, a boutique talent acquisition consulting firm has been retained under contract to assist  a growth oriented Biotechnology company in completing a critical search for a Director, able to manage the full lifecycle of file and approval for a major new drug.

Coronary artery disease is the #1 cause of death globally and has become the leading burden on healthcare.

How can coronary artery disease be tackled? 

First with prevention. But these efforts take generations to implement; at enormous costs; without complete effect.

Second with intervention. When prevention programs are absent or fail, the risk of death is high. It jumps dramatically the moment that an atherosclerotic plaque in a coronary or cerebral artery ruptures. Thrombosis that follows may block the artery, cut of oxygen supply and kill in a matter of minutes. We want to stop and reverse this deadly progression of cardiovascular disease.

As the CEO of our client stated the drug under development has “game-changing potential to address the unmet needs of millions of at risk…patients worldwide who continue to struggle with high cholesterol”.

What if YOU were part of the leadership team that brought that scale of change to the market?

What if YOU developed a therapeutic solution built upon the convergence of Nobel Prize winning science and a proven track-record for innovative drug development and in doing so, changed an industry?

How satisfying would it be to know YOU changed the health outcomes for the better for millions of people around the world and in the process reduced the rising cost of care?

The Science

Millions of people take statins every day to help manage their LDL-C cholesterol levels and have done so for years. Recent research has identified PCSK9 as a new target, opening the door for new treatments that could significantly improve patient outcomes, however the initial products are too expensive for the outcomes they deliver.

Our client is bringing to market a new product that will could change the paradigm. Phase II trials indicate significant lowering of LDL-C via a treatment that may only need to be taken twice a year and delivered at a price point far more affordable than competitors. Utilizing Nobel Prize winning methods for RNA interference that targets PCSK9 and silences it, the new drug enables the body to more effectively lower “bad” cholesterol and possibly your risk of dying from heart disease.

As the Project Director, Global Drug Approval you will;

• Be a senior founding member of the next chapter in cardiovascular medicine.
• Join a firm that has an established track record as a world leader in bringing innovative new drugs to market.
• Experience the exhilaration of a start-up of 50-60 talented people, while leveraging the reputation of a publicly traded and respected company with plenty of financial muscle.
• Manage the critical development channel tasked with completing the requisite Phase III registration trials of Inclisiran.
• How well you manage the filing and approval process of the Phase III trial will have a direct impact on the future of our client and potentially millions of people struggling with high LDL-C cholesterol.

Are you ready for that opportunity?

Are you ready to;

• Manage the complete lifecycle for file and approval of a global Phase III clinical trial?
• Maintain a vision across every aspect of the trial program, constantly moving between vision, strategy and execution, to anticipate and course correct as needed?
• Take a qualitative approach to program execution, while simultaneously ensuring the trial delivers on time and on budget?
• Interact with internal and external stake-holders, clinical trial managers and others to maintain effective communication channels?
• Be able to listen to other perspectives and synthesize valuable input to improve the project while also standing your ground on critical program aspects if challenged?
• Oversee an agile organization and lead through influence, knowledge and dedication as opposed to direct authority?
• Ensure seamless integration and coordination with all other program streams such as manufacturing/supply chain, post-trial outcomes studies, alignment with customers and post approval strategy?

Work Experience:

• Proven record of leading a project that took a product successfully through a large global trial, including all necessary filing and FDA approval.
• The ability to work in a small close knit team where you must “do as well as lead”. Preferably prior experience in a start-up or small to mid-size pharmaceutical or biotechnology firm focused on product development.
• Demonstrated record of effective integration with post-trial, activities designed to bring the product to market, including supply chain and positioning/pricing.
• Prior knowledge and experience in the area of cardiovascular product development would be beneficial.

Educational Background:

• Scientific or Life Sciences Bachelor’s Degree.
• MBA or Masters desirable.

Established in 2010, Talent Orchard has an exceptional reputation, providing staffing solutions to time-sensitive, talent scarcity issues to deliver better talent management ROI.  Our specialty lies in the critical area of program talent acquisition and resource management, not in one narrow skillset, but across many areas of technical and functional delivery.

To learn more about our other exciting opportunities, visit our Jobs Page at www.talentorchard.com.

@talentorchard