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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
As the head of quantitative pharmacology area, the responsibilities of this position are to provide strategic and mentoring leadership, subject matter expertise, direction and hands on support of the activities and growth of this function with an appropriate but non-exclusive emphasis on population PK and PK/PD modeling. This position will also have responsibility for the SAS programing, dataset management, and creation of needed TFLs within the pharmacometric function.
- This individual will lead the quantitative pharmacology function within Regeneron; providing strategic and mentoring leadership, 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 development portfolio.
- Mentor and develop the scientific quantitative pharmacology staff.
- Responsible for managing SAS programing activities and personnel within the Pharmacometric function; tasked with the creation of submission ready PK and PKlPD analysis sets (eg. AdaM and NONMEM data sets) and TFLs for clinical pharmacology and quantitative pharmacology reports.
- Ultimately accountable for the strategy, execution and delivery of population PK and PKlPD 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.
- 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 modeling and simulation strategies, with innovative quantitative methods and a variety of unique response variables to develop novel and informative PKlPD models in the advancement of drug candidates.
- Foster and maintain effective and positive collaborations across the organization including Clinical Sciences, Translational and Predictive Medicine, Statistics and Clinical Database Management, as well as the sister functions within Pharmacometrics; Pre-clinical PK and Clinical Pharmacology.
- Develop collaborative relationships with the colleagues across the pharmaceutical industry.
- Publish innovative quantitative pharmacology manuscripts.
- 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, PKlPD 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 in state of the art and innovative methods of population PK and PKlPD 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 non-population analysis methods 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 PKlPD reports, regulatory summary documents, responses to global health authority inquiries, and other regulatory documents.
- Experienced in the application of quantitative approaches to drug development.
- Hands on experience in population modeling and simulation.
- Possess strong scientific and technical expertise in the application of quantitative pharmacology and population PK modeling in drug development.
- 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.