Associate Director, Quantitative Pharmacology Oncology
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases . The Director, Quantitative Pharmacology Oncology Lead will provide direct support to the Sr. Director of Quantitative Pharmacology, providing strategic and scientific expertise, as well as representing Quantitative Pharmacology across the Regeneron organization. This position will be accountable for developing and applying quantitative frameworks that enable model-informed drug discovery and development across the Regeneron Oncology and Immunoncology portfolio. In addition, this position will ensure quantitative rigor and quality in all deliverables through direct scientific mentorship and management of other QP professionals . Responsibilities . Assist in the leadership of the Quantitative Pharmacology Department, and directly manage and mentor other QP professionals . Lead and supervise all model-based activities in support of Oncology portfolio and provide direct hands-on modeling expertise on select Oncology programs . Develop and execute comprehensive quantitative pharmacology strategic plans and leverage, where appropriate, disease-specific quantitative frameworks quantitative systems pharmacology, comparator models, etc. to inform critical program questions as well as internal and regulatory decisions . Work closely with Clinical Pharmacology colleagues to develop and deliver quantitative strategies to support assigned clinical development plans . Provide quantitative pharmacology and disease area subject matter expertise to both Discovery and Development teams . influence the collection and use of nonclinical and biomarker data to inform human pharmacology, dose selection, and study design . Oversee the development and execution of modeling analysis plans to support regulatory/submission deliverables . Responsible for overseeing and guiding the scientific rigor, productiveness, and biological suitability of models and methods developed within team through mentoring scientists in specifics of relevant disease pharmacology/biology as well as review of model code, diagnostics, VPCs, and other output . Work closely with Clinical Pharmacology and Regulatory to provide appropriate quantitative pharmacology content to regulatory documents, communications and presentations as needed IND, health authority inquiries, preparation/participation in meetings with health authorities, preparation of BLA summary sections, addressing review inquiries, health authority sponsored Advisory Committee Meetings, etc . Oversee preparation and review of PopPK, PKPD, ER, and other quantitative pharmacology reports and publications. Work with Clinical Pharmacology and Medical Writing to incorporate QP sections into clinical study reports . Partner with the Preclinical Pharmacokinetic/Pharmacodynamics Team to enable translational PKPD efforts in the Discovery space . Requirements . Education . PhD in Engineering, Pharmaceutical Sciences PKPD emphasis or other computational/quantitative discipline. Experience . 8 plus years of experience in the application of quantitative pharmacology in a drug discovery/development setting including experience managing and developing PhD modelers . Expertise in population analysis methodologies . knowledgeable in the use of a variety of computational tools including NONMEM, Monolix, R, Matlab, etc . Experience in mechanistic/semi-mechanistic pharmacological modeling as well as development of exposure-response, PKPD, disease, and/or QSP models in Oncology/Immunoncology therapy area strongly preferred . This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business . To all agencies . Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid . Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.