Sr Dir Preclinical & Translational PK/PD

Regeneron Pharmaceuticals, Inc.; Village of Tarrytown (NY); Vor Ort; USD 242.000 - 403.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals, Inc. seeks a Senior Director to oversee PK/PD for early-stage drug discovery through IND/CTA.

You will lead PK/PD analyses, guide study designs, and coordinate with Therapeutic Proteins, Assay Development, and Clinical Pharmacology teams to support regulatory submissions. You will influence projects across the organization, drive strategic PK/PD programs, and participate in development of data packages for regulatory submissions.

Qualifikationen

• PhD and 12–14+ years of biotech/pharma experience.
• Deep PK/PD knowledge for therapeutic proteins; siRNA, CRISPR therapeutics welcomed.
• Proven ability to plan, coordinate, and lead PK/PK/PD studies and analyze data.
• Excellent written and verbal communication, presentation, and leadership skills.
• Familiarity with PK/PD software and data visualization/AI tools.

Aufgaben

• Serve as SME for Preclinical and Translational PK/PD on Discovery-stage projects; guide PK/PD study design.
• Collaborate with Therapeutic Proteins, Assay Development, and Clinical Pharmacology teams to develop PK/PD strategies.
• Coordinate with teams to oversee in vivo preclinical studies and report PK/PD analyses.
• Derive FIH dose predictions with Clinical Pharmacology and support regulatory submissions.

Kenntnisse

PK/PD expertise

Leadership

Data analysis

Strategic planning

Scientific communication

Ausbildung

PhD in Pharmacology/Pharmacokinetics/Biology or Biochemistry

Tools

WinNonLin

Data visualization

AI software

Jobbeschreibung

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

Does this sound like you?

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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. 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, and 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.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

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.

If you have any questions, please speak with your recruiter.

Salary Range (annually)

$242,000.00 - $403,300.00