Regeneron Pharmaceuticals, Inc

Pharmacokineticist, PPK/PD

Regeneron Pharmaceuticals, Inc • $109K — $179K *
Tarrytown, NY 10591In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree with 5-7 years or MSc with 3-5 years of experience in pharmacokinetics
  • Deep understanding of pharmacokinetics concepts and techniques
  • Proficient in software like Phoenix WinNonlin; experience with NLME/population PK is a plus
  • Experience in designing and conducting animal PK/TK studies
  • Capable of performing advanced pharmacometric techniques and mentoring junior staff
  • Familiar with GLP environment and SOP compliance

Responsibilities

  • Lead non-compartmental and compartmental PK/PD analyses for studies
  • Ensure compliance with GxP standards and regulatory submission requirements
  • Prepare and quality control CDISC SEND datasets from CRO and internal bioanalytical data
  • Support and coordinate CRO study activities and serve as primary contact
  • Deliver Pharmacometrics outputs, setting methodology and best practices
  • Produce and format regulatory document tables and listings using validated tools
  • Create and review graphical outputs for study reports and submissions

Benefits

  • Inclusive workplace culture
  • Opportunity to work in a scientifically innovative environment
  • Mentorship opportunities for professional development
  • Impactful role in the development of life-changing medicines
  • Access to advanced software tools and technologies
  • Participation in building and setting best practices
Full Job Description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Pharmacokineticist for PPK/PD to serve as a senior independent contributor in the Translational Pharmacokinetics and Pharmacodynamics (TPK/PD) Group, taking ownership of PK/PD analyses end-to-end and serving as a pharmacokinetics point of contact across assigned studies. This person will independently plan and execute non-compartmental and compartmental PK/PD analyses in support of nonclinical and (potentially) clinical studies using Phoenix WinNonlin and other analysis software, and will prepare and quality-control standardized datasets from CRO and internal bioanalytical data for regulatory submission. This person will lead PK/TK protocol design/input, support CRO studies, produce Pharmacometrics deliverables and regulatory tables/figures/listings, contribute to standard-setting and best practices for the group, and mentor and provide technical guidance to junior analysts, following all SOPs to ensure GxP/GLP compliance.


When & Where:


This role will sit at our Tarrytown, NY office and is expected to be on-site 4 days per week.


Discover Your Role:


  • Independently leads, performs, and takes ownership of non-compartmental PK and compartmental PK/PD analyses in support of nonclinical and (potentially) clinical studies, according to GxP as appropriate, and serves as the pharmacokinetics point of contact and lead analyst for assigned studies.
  • Conducts compliance-related activities (SOPs, etc.); ensures regulatory-submission conformance, data integrity, and GxP compliance; adheres to controlled SOPs; helps set group standards by authoring/revising SOPs and providing senior compliance review of others' deliverables; and meets mandatory-training and data-confidentiality requirements.
  • Owns the preparation, quality control, and senior review of standardized CDISC SEND datasets (e.g., PC/PP domains and associated SUPPQUAL) from CRO and internal bioanalytical data, with auditable, source-traceable derivations that conform to controlled terminology and regulatory-submission standards, and sets and maintains the dataset standards and conventions the group follows.
  • Owns and leads CRO study support; tracks study requirements, project priorities, status, and milestones; serves as the primary PK point of contact and liaison to CROs and functional groups; and drives coordination across the study lifecycle.
  • Independently owns and executes a broad array of work supporting department priorities in routine and non-routine Pharmacometrics deliverables on study design, analysis, and reporting, and sets methodology and best-practice standards for the group.
  • Produces and formats tables and listings (TFLs), including PK concentration and parameter summaries, for regulatory documents using validated tools (e.g., Phoenix WinNonlin, R), and owns, sets, and reviews against the group's consistent, submission-ready presentation standard.
  • Produces and reviews figures and graphical outputs (e.g., concentration-time profiles) for study reports and regulatory submissions using validated tools, and owns and sets the group's graphical presentation standard.

This Role Requires:


  • Bachelors degree with 5-7 years of professional experience, or a Masters degree with 3-5 years of professional experience
  • Strong, in-depth understanding of pharmacokinetics concepts and techniques
  • Proficient in relevant software, including Phoenix WinNonlin; knowledge of NLME/population PK a plus
  • Experience in animal PK/TK studies, including protocol design & study conduct
  • Able to clearly describe and perform advanced pharmacometric techniques, interpret results independently, and mentor and provide technical guidance to junior staff
  • Ability to help set group standards and best practices, with experience working in a GLP environment and following SOPs

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture.


Salary Range (annually)

$109,900.00 - $179,300.00

About Regeneron Pharmaceuticals, Inc

Regeneron Pharmaceuticals is a biopharmaceutical company that discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions. The Company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. The company’s product portfolio includes EYLEA, an aflibercept injection; ARCALYST, a rilonacept Injection for subcutaneous use; ZALTRAP for metastatic colorectal cancer; trap fusion proteins; and fully human monoclonal antibodies. On March 26, 2012, it was announced that Sanofi and Regeneron are in development with a new cholesterol drug which will help reduce cholesterol up to 72%. Regeneron Pharmaceuticals was founded in 1988 and is currently headquartered in New York, USA.

Regeneron Pharmaceuticals, Inc Careers

Join the innovative team at Regeneron Pharmaceuticals, Inc, a leading biotechnology company renowned for its commitment to science-driven solutions. This is an unparalleled opportunity to advance your career with a company at the forefront of medical breakthroughs and clinical research.

Work You’ll Do

At Regeneron Pharmaceuticals, Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that directly contributes to the health and well-being of populations globally. Our diverse team of professionals is dedicated to pioneering developments in biotechnology through continuous innovation and rigorous research.

Explore Job Opportunities and Growth

Regeneron offers a variety of job opportunities that encourage professional growth and personal achievement. Whether you're seeking an entry-level position or a more senior role, you will find a path that aligns with your career ambitions and skills. Our supportive culture emphasizes leadership development and diversity training, ensuring every team member can thrive.

Internship Programs

Kickstart your career with a Regeneron internship. Our programs provide invaluable industry experience, mentoring from seasoned professionals, and opportunities to develop skills that are crucial in the biotech field. Interns at Regeneron gain hands-on experience, contributing to projects that matter.

Benefits and Culture

Choosing to work at Regeneron Pharmaceuticals, Inc means choosing a career that comes with competitive benefits designed to support you both professionally and personally. We offer comprehensive health benefits, retirement plans, and wellness programs. Our inclusive culture fosters an environment where every employee can flourish, driven by collaboration and mutual respect.

Innovation and Leadership

Lead the way in biotechnological innovation with Regeneron. Our leadership is constantly looking towards the future, investing in cutting-edge technology and research that pave the way for medical advancements. At Regeneron, leadership and innovation go hand in hand, creating a dynamic where breakthroughs are common.

Networking and Professional Development

Enhance your professional network and skill set through Regeneron’s extensive networking opportunities and ongoing professional development programs. We believe in nurturing our talent with advanced training sessions and regular workshops that cover the latest trends and technologies in the biotech industry.

Join Our Team

Discover the impact you can make in a career at Regeneron Pharmaceuticals, Inc. Search for open positions that match your skills and interests. We are continuously hiring and looking for passionate, curious, and innovative team players.

Stay Connected

Keep up to date with the latest at Regeneron by following our careers blog. Gain insights from the experts and learn more about the exciting world of biotech at Regeneron Pharmaceuticals, Inc.

Prepare for Your Interview

Ready to join us? Prepare your resume and refine your interview skills to become part of a company that’s dedicated to changing lives. Personalize your job search and get tailored job alerts directly to your inbox, so you never miss an opportunity to be part of our team. At Regeneron Pharmaceuticals, Inc, your career is poised for tremendous growth and innovation. Explore the opportunities today and be part of a team that’s shaping the future of biotechnology.
Learn more about Regeneron Pharmaceuticals, Inc
Size
10,368 employees
Market Cap
$78.1 billion
Industry
Pharmaceuticals & Biotech
Net Income
$3.5 billion
Founded
1988
5 Year Trend
+27%
Revenue
$8.4 billion
NASDAQ
REGN
* Ladders Estimates

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