Director, Oncology TA Global Regulatory Affairs ...

DIRECTOR, ONCOLOGY TA GLOBAL REG AFFAIRS STRATEGY LEAD Growing $1.5Bn+ PharmaUnique and positive cultureRETAINED SEARCHCornerstone 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 in-licensing efforts. This hybrid role will lead US and Global regulatory activities in their Oncology therapeutic area, serve as the regulatory expert on cross-functional product development teams globally on their unpartnered assets, 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. Our client is seeking an entrepreneurial and experienced oncology regulatory affairs professional who values working with like-minded high EQ GTD 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 multi-billion dollar 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 culture that has made it 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 Metro area (on-site or hybrid)Our client is focused on hiring the right person rather than the right location, so they are comfortable with candidates who need a limited on-site or 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-class teract with the FDA and global regulatory authorities.Take responsibility for the preparation and content of regulatory dossiersdocuments (e.g., INDs, CTAs, BRDScientific Advice Requests, and NDAsMAAs).Ensure that product development programs are aligned with US and global commercial 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: 5-10 years of pharmabiotech company Regulatory Affairs experience, with an emphasis in Oncology and demonstrated experience defining and leading clinical-stage regulatory D filing and ideally also NDABLA filing 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.BABS required.*PLEASE NOTE*: For "high potential" individuals who may not have all enough of the experiences sought, our client will consider candidates at the Associate Director level.CONTACT:Corey S. Ackerman, JD | Senior | x 716CORNERSTONE SEARCH GROUP - Life Sciences Executive Search1200 Morris Tpke, Suite 3005, Short Hills, NJ (USA)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.Representative Retained Search Assignments:CEO | specialty pharma start-upCEO | regenerative medicine start-upUS CEO | established European small pharmaPresidentUS Commercial Head | generics pharmaCMO | late-stage public biotechCMO | mid-size pharmaCSO | mid-size global biotechSVP, Head of Global Medical Affairs | mid-size oncology companySVP, Head of Global Clinical Development | multi-TA mid-size pharmaSVP, Head of Global Regulatory Affairs | late-stage Israeli biotechGroup VP, Global Commercial Head | API Business Unit | Indian pharmaVP, Data Science RWE | Top 5 pharmaVP, Head of Regulatory Affairs | Boston biotechVP, US Head of Regulatory Affairs | Top 20 pharmaVP, Head of R&D Operations | Boston biotechVP, Head of HEOR (Health Economics & Outcomes Research | Top CNS specialty pharmaVP, Head of US HEOR & RWE | Top 5 pharmaVP, Head of Real-World Evidence | Top 5 pharmaVP, Head of US HEOR | Top oncology pharmaED, Head of HEOR | Top West Coast pharmaVP, Head of Global Market Access | Top oncology specialty pharmaVP, Head of US Market Access | High-profile late-stage biotechVP, Head of US Market Access | West Coast late-stage public biotechVP, Head of HemeOnc Clinical Research | Public oncology biotechVP, Head of Clinical Development | late-stage anti-infectives UK pharmaVP, Head of Global Drug Safety & PV | Chinese oncology biotechED, Head of Clinical Operations | British VC-backed biotechED, Global Commercial Strategy Franchise Head | Top rare disease Boston pharmaED, Head of Global Clinical Pharmacology | Public oncology biotechED, Head of Global HEOR | Large US pharmaHead, Patient Advocacy | European commercial-stage rare disease biotechDirectorHead, QSP Modelling | Mid-size European pharmaMedical Directors (DirectorSDED levels) in Translational Medicine Clinical Development Medical Affairs Drug Safety: 75+ retained assignmentsHEORRWEMarket Access (ADDirectorSDED levels): 100+ retained assignmentsCornerstone's Privacy Policy: Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted to us as confidential information. 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Created: 2024-11-02