Director, Global Regulatory Affairs Strategy Lead - Oncology (multiple assets) | $7Bn mkt cap biotech | Hybrid | RETAINED SEARCH - Cornerstone Search Group : Job Details

DIRECTOR, GLOBAL REG AFFAIRS STRATEGY LEAD - ONCOLOGY

• Growing $1.5Bn+ revenue, $7Bn market cap, 550-person biotech
• 1 approved cancer blockbuster with 1 anticipated blockbuster in late Phase III
• Highly collaborative, no ego, transparent culture
• Strong female leadership representation including CEO and Head of R&D
• Globally lead multiple assets including 1st-in-class solid tumor candidates

Cornerstone Search Group has been retained again by a profitable $1.5Bn+ (and growing) pharma with a uniquely positive work environment that reflects its country's renowned culture. With a product portfolio featuring a current oncology blockbuster that is still on the ascent and the upcoming launch of another anticipated oncology blockbuster, this company is in a very active phase of building out their clinical pipeline through both in-house research and acquisition. This hybrid role will lead US and Global regulatory activities in their Oncology therapeutic area on a potential first-in-class asset, serve as the regulatory expert on cross-functional product development teams globally on unpartnered assets and work with other pharmas on their partnered assets, and serve as the point of communications with the FDA on their product portfolio. You will have regular interaction with their very accessible senior management team, including the Head of R&D. Our client is seeking an entrepreneurial and experienced oncology regulatory affairs professional who values working with like-minded high EQ people in a high collaboration / low bureaucracy environment and has a passion for drug development.

5 ATTRACTIVE FEATURES:

(1) Uniquely attractive opportunity to join a growing, profitable, publicly-traded company with a $7Bn market cap that still retains a small company feel with very few layers.

(2) Our client's marketed products include a fast-growing cancer blockbuster, and their lead clinical candidate is in Phase III and is anticipated to also become a blockbuster.

(3) This company takes pride in its home country's reputation as one of the world's happiest countries.

(4) We have partnered with this client multiple times before, so we know them quite well. The people that we have helped them hire have been very happy with the culture and impressed with executive management and their peers.

LOCATION: New York City (Hybrid)

Our client is focused on hiring the right person rather than the right location, so they are comfortable with candidates who need a hybrid arrangement. They can offer relocation assistance as well.

RESPONSIBILITIES in a NUTSHELL:

• Develop and execute US and Global regulatory submission strategy for oncology assets, featuring a lead asset with first-in-pathway/first-in-class potential.
• Interact with the FDA and global regulatory authorities.
• Take responsibility for the preparation and content of US and global regulatory dossiers/documents (e.g., INDs, CTAs, BRD/Scientific Advice Requests, and NDAs/MAAs).
• Ensure that product development programs are aligned with US and global commercial strategy.
• In addition to the company's wholly owned assets, interact with other pharmas on JV-partnered assets.
• Lead internal company forums for the sharing of best practices and lessons learned.
• Stay on top of emerging issues that may impact regulatory product strategy and adjust accordingly. Assess scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines in order to make recommendations.

DESIRED SKILLS/ QUALIFICATIONS / EXPERIENCES / BEHAVIORS:

• 3-7 years of pharma/biotech oncology regulatory affairs experience with demonstrated experience defining and leading clinical-stage regulatory strategy.
• IND filing experience and ideally also NDA/BLA filing experience.
• In depth working experience of US regulatory affairs, including FDA interaction experience, coupled with an understanding of EU, ICH, and other global requirements.
• Experience with preparing, reviewing, and submitting FDA Clinical modules. CMC and Nonclinical module experience would be a plus.
• Operational experience with regulatory submissions to the FDA (e.g., INDs and NDAs). It would be a plus, but not a requirement, to have EU submission experience (e.g., CTAs and MAAs) or other global regulatory submission experience.
• Experience with novel or expedited regulatory pathways would be a plus but is not required.
• Seeking a proactive, self-motivated, and entrepreneurial individual who has the ability to prioritize and get things done.
• Seeking a biotech mindset - someone who is innovative in their approach, intellectually inquisitive, has a flexible personality and high EQ, and is highly collaborative.
• PLEASE NOTE: For high potential individuals who may not have enough of the experiences sought, our client will consider candidates at the Associate Director level.

CONTACT:

Corey S. Ackerman, JD | Senior Partner

[email protected] |

973.###.#### x 716

CORNERSTONE SEARCH GROUP - Life Sciences Executive Search

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www.cornerstonesg.com

Cornerstone Search Group, recognized by Forbes as one of the Top 100 Executive Search Firms and by Hunt Scanlon as one of the Top 50 Healthcare & Life Sciences Executive Search Firms , is a Life Sciences Executive Search firm that helps companies based around the world, ranging from startup biotechs to Top 10 pharmas, to find, attract, and hire talent for their US and globally based leadership positions (CxO and xVP levels) as well as their critical Director-level roles.

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• Medical Directors (Director/SD/ED levels) in Translational Medicine / Clinical Development / Medical Affairs / Drug Safety: 75+ retained assignments
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