Head of Quantitative Pharmacology

Location
Tarrytown, NY, United States
Posted
Aug 05, 2019
Ref
17276BR
Required Education
Doctorate/PHD/MD
Position Type
Full time
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.

Summary:
As the Head of the Quantitative Pharmacology area, the responsibilities of this position are to provide strategic leadership, subject matter expertise, mentorship, direction and hands on support of the activities and growth of quantitative pharmacology function. While quantitative activities will have an emphasis in population PK and PK/PD modeling, the Head of QP will be responsible for the effective development and application of a broad spectrum of quantitative approaches.

Responsibilities:
  • This individual will lead the quantitative pharmacology function within Regeneron; providing strategic leadership, mentorship and subject matter expertise in the area of quantitative pharmacology, as well as hands-on support as needed, in support of on-going clinical development programs and global market applications.
  • Continued development and management of the Quantitative Pharmacology Function within the organization to meet growing needs of the organization and the development portfolio.
  • Mentor and develop the scientific quantitative pharmacology staff.
  • Ultimately accountable for the strategy, execution and delivery of quantitative assessment including population PK, PK/PD, and QSP modeling in support of dose-selection from FIH through phase 3, as well as the clear description of these quantitative pharmacology activities in study reports and regulatory summary documents required for global market applications (BLA, sBLA, MAA, Type 2 variations etc.).
  • Responsible for development and implementation of quantitative pharmacology strategy to support research, early to late stage clinical development, and global regulatory submissions.
  • Stimulate innovation, exploring new quantitative pharmacology methodologies to support drug development programs.
  • Integrate state of the art quantitative assessment to include but not limited to modeling and simulation strategies, to provide innovative quantitative methods using a variety of unique response variables to develop novel and informative PK/PD models for the advancement of drug candidates.
  • Foster and maintain effective and positive collaborations across the organization including Clinical Science, Early Clinical Development, Predictive Medicine, Statistics, as well as the sister functions within Pharmacometrics; Pre-clinical PK/PD and Clinical Pharmacology.
  • Develop collaborative relationships across the pharmaceutical industry and academia.
  • Publish innovative quantitative pharmacology manuscripts.

Requirements:
  • Ph.D or Pharm.D. with a concentration in pharmacokinetics, pharmaceutical sciences, mathematics, engineering, or other related disciplines.
  • 15+ year relevant experience in population PK, PK/PD modeling & simulation, and quantitative pharmacology in the pharmaceutical industry.
  • Highly experienced at independently managing a multi-personnel function with multiple activities across a broad corporate portfolio.
  • Highly skilled with hands-on experience of state of the art and innovative methods of population PK and PK/PD modeling
  • Highly experienced in the application of quantitative pharmacology activities in the clinical development of monoclonal antibodies or other therapeutic proteins.
  • Experienced and willing to employ appropriate analysis methods [including non model-based approaches] to address quantitative pharmacology needs in a drug development program.
  • Experienced in global submission of population PK analysis and analysis data sets.
  • Exceptional verbal, written and presentation skills is a must.
  • Experienced in drafting and finalizing population PK and PK/PD reports, regulatory summary documents, responses to global health authority inquiries, and other regulatory documents.
  • Strong leadership and organizational skills.

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.