Sr Dir Preclinical & Translational PK/PD
Regeneron Pharmaceuticals
Summary
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Director to support PK and PK/PD requirements for early-stage drug discovery through IND/CTA projects. You'll utilize a mastery level of PK/PD knowledge and strategic leadership skills to effectively develop and implement strategic analyses supporting research and development projects. You'll exert influence across the organization at multiple levels, including individual contributors (in and out of the function), development program teams, and other functional managers, and will be accountable for the PK/PD evaluation of a portfolio of projects and/or highly complex programs/platforms that can be wide in scope.
Job description
This role is suited for individuals who thrive in a fast-paced, collaborative environment, are passionate about science and motivated to contribute to bringing new drugs to patients, and desire exposure to multiple therapeutic areas and emerging modalities. We're looking for seasoned and tenured scientists with a demonstrated ability to provide significant impact on the organization and external groups, readily able to influence and effect change.
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
Requirements
- A PhD in Pharmacology, Pharmacokinetics, Biology/Molecular Biology, or Biochemistry
- 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
- 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
- Extensive experience writing scientific reports and regulatory summaries
Benefits
- Annual bonuses
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, Dental & Vision
- Life and disability insurance
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.