Regeneron Pharmaceuticals, Inc

Sr Dir Preclinical & Translational PK/PD

Regeneron Pharmaceuticals, Inc • $242K — $403K *
Tarrytown, NY 10591In-Person
Pharmaceuticals & Biotech
11 - 15 years of experience
Today
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Job Overview by Ladders

Qualifications

  • PhD in Pharmacology, Pharmacokinetics, Biology/Molecular Biology, or Biochemistry with 12-14 years of relevant experience in biotech or pharma.
  • Deep understanding of PK and PD, especially for therapeutic proteins and modalities like siRNA and cell therapies.
  • Proven experience in planning, coordinating, and leading PK/PD studies with data analysis skills.
  • Strong written and verbal communication, presentation, and leadership abilities.
  • Familiarity with PK/PD software (e.g., WinNonLin) and experience in writing scientific reports and regulatory summaries.

Responsibilities

  • Serve as a subject matter expert in Preclinical and Translational PK/PD for Discovery-stage project teams.
  • Collaborate with internal groups to develop and execute PK/PD strategies for projects.
  • Provide oversight for preclinical in vivo studies and coordinate with scientific teams.
  • Manage nonclinical PK and PK/PD studies, conducting and reporting analyses based on preclinical data.
  • Analyze and present PK and PK/PD data to project teams and senior management.
  • Derive first in human (FIH) dose predictions in collaboration with Clinical Pharmacology.
  • Prepare summary reports for regulatory submissions and communicate project expectations to management.

Benefits

  • Opportunity to work on cutting-edge therapeutic modalities like CAR-T and gene therapy.
  • Collaborative environment with cross-functional teams in a leading biotech firm.
  • Access to ongoing professional development and training in the latest scientific advancements.
  • Involvement in regulatory submissions that impact drug development and patient care.
Full Job Description
  • Location: Tarrytown, NY

Discover your role:

  • Serves as a subject matter expert regarding Preclinical and Translational PK/PD on Discovery-stage project teams, guiding the design of preclinical pharmacology, PK, and PK/PD studies
  • Collaborates with various internal groups such as Therapeutic Proteins, Therapeutic Function Areas, Assay Development, Precision Medicine, Preclinical Operations, and TPK/PD management to develop and execute PK/PD strategies for projects
  • Provides input and oversight for preclinical in vivo studies, coordinating with scientific teams conducting these studies
  • Manages nonclinical PK and PK/PD studies, and conducts and reports PK/PD analyses based on data from preclinical studies
  • Analyzes and presents PK and PK/PD data to project teams, TPK/PD, and senior management
  • Derives first in human (FIH) dose predictions in collaboration with Clinical Pharmacology
  • Works closely with Toxicology, Pathology, Clinical Pharmacology, and Quantitative Pharmacology teams within the Drug Safety and Pharmacometrics department to deliver data and regulatory documents supporting project progression
  • Prepares summary reports for regulatory submissions
  • Effectively communicates project team queries, expectations, and timelines to management
  • Maintains current knowledge of scientific literature, regulatory guidance, and best practices related to PK/PD of protein therapeutics, siRNA, CAR-T, and gene therapy modalities

This role requires:

  • A PhD in Pharmacology, Pharmacokinetics, Biology/Molecular Biology, or Biochemistry, with more than 12-14 years of relevant experience in biotech or pharma
  • Deep theoretical and applied understanding of PK and PD to interpret the pharmacology and biology of therapeutic proteins; experience with other modalities such as siRNA, peptide-conjugates, CRISPR-based therapeutics, and cell therapies is highly beneficial
  • Proven ability to plan, coordinate, and lead PK and/or PK/PD studies, and analyze related data
  • Excellent written and verbal communication, presentation, influencing, and leadership skills
  • Familiarity with PK/PD software (e.g., WinNonLin), data visualization and AI software, and extensive experience writing scientific reports and regulatory summaries


Salary Range (annually)
$242,000.00 - $403,300.00

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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