Sr Dir Preclinical & Translational PK/PD

Regeneron Pharmaceuticals, Inc (USA); Village of Tarrytown (NY); On-site; USD 242,000 - 403,000; Full time

Benefits offered by this job

Bonus plan

Equity awards

401(k) match

Health benefits

Paid time off

Job summary

Regeneron Pharmaceuticals, Inc is seeking a Senior Director to lead PK/PD strategy across early-stage drug discovery to IND/CTA. You will influence cross-functional teams and design translational PK/PD programs to support decision-making.

Based in Tarrytown, NY, you will oversee in vivo studies, collaborate with toxicology and clinical pharmacology, and prepare regulatory summaries while driving innovation in protein therapeutics and emerging modalities.

Qualifications

• PhD in Pharmacology, Pharmacokinetics, Biology or Biochemistry with extensive biotech/pharma experience.
• Deep theoretical and applied understanding of PK/PD for therapeutic proteins and related modalities.
• Proven ability to plan, coordinate, and lead PK/PD studies and analyze data.
• Excellent written and verbal communication, presentation, and leadership skills.

Responsibilities

• Serve as SME for Preclinical and Translational PK/PD on discovery-stage teams.
• Design preclinical pharmacology, PK, and PK/PD studies and strategies.
• Oversee nonclinical PK/PD studies and coordinate with internal groups.
• Analyze PK/PD data and present to teams and senior management.
• Derive FIH dose predictions with Clinical Pharmacology input.
• Prepare regulatory summaries and ensure timely project progression.

Skills

PK/PD expertise

Leadership

Scientific reporting

Presentation

Education

PhD in Pharmacology/PK/Biology/Biochemistry

Tools

WinNonLin

Data viz tools

Job description

Build our future together: 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. 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. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

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

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

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

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company's Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.