Sr Dir Preclinical & Translational PK/PD

BioSpace; Village of Tarrytown (NY); On-site; USD 242,000 - 403,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension plan

401(k) match

Health and wellness

Fitness centers

Insurance benefits

Paid time off

Family support

Job summary

Regeneron seeks a Senior Director to lead PK/PD analyses for early-stage drug discovery through IND/CTA projects at its Tarrytown, NY site. You will guide preclinical pharmacology, PK, and PK/PD study designs and coordinate across Therapeutic Proteins, Assay Development, and Clinical Pharmacology teams to deliver robust data.

The role requires a PhD and extensive PK/PD expertise, with strong leadership and communication skills to influence internal and external groups.

Qualifications

• PhD 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

Responsibilities

• 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

Skills

PK/PD expertise

Leadership

Regulatory familiarity

Education

PhD in Pharmacology/Biology/ Biochemistry

Tools

WinNonLin

Data visualization

AI software

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 1214 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

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.

Benefits

• 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

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Salary Range (annually)

$242,000.00 - $403,300.00

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.