Associate Director Preclinical & Translational Pharmacokinetics/Pharmacodynamics

Regeneron Pharmaceuticals; Tarrytown (GA); On-site; USD 176,000 - 287,000; Full time

Job summary

Regeneron Pharmaceuticals in Tarrytown is seeking an Associate Director to support PK/PD for early-stage drug discovery and IND projects. You will guide preclinical PK studies, coordinate with cross-functional teams, and analyze PK/PD data for project teams and senior management.

You will prepare summaries for regulatory submissions and maintain knowledge of PK/PD literature and best practices. This on-site role requires a leadership mindset and collaboration across Toxicology, Clinical

Qualifications

• PhD in Pharmacology, Pharmacokinetics, Biology/Molecular Biology, or Biochemistry.
• Deep theoretical and applied understanding of PK and PD to interpret pharmacology of therapeutic proteins.
• Proven ability to plan, coordinate, lead PK and/or PK/PD studies, and analyze data.
• Familiarity with PK/PD tools (WinNonLin), data visualization and AI software; ability to write scientific reports and regulatory summaries.

Responsibilities

• Serve as SME on Preclinical PK/PD within Discovery-stage project teams and guide study design.
• Collaborate with Therapeutic Proteins, Therapeutic Function Areas, Assay Development, Precision Medicine, Preclinical Operations, and PPK/PD management to develop PK strategies.
• Effectively communicate project queries, expectations, and timelines to management.
• Conduct and report PK/PD analyses based on preclinical study data.
• Work with Toxicology, Pathology, Clinical Pharmacology, and Quantitative Pharmacology teams to deliver data for regulatory submissions.
• Maintain current knowledge of literature, regulatory guidance, and PK/PD best practices.

Education

PhD in Pharmacology, Pharmacokinetics, Biology/Molecular Biology, or Biochemistry

Tools

WinNonLin

Data visualization software

AI software

Job description

Build Our Future Together

The Associate Director role involves supporting Pharmacokinetics (PK) and Pharmacokinetics/Pharmacodynamics (PK/PD) requirements for early-stage drug discovery and IND projects. Responsibilities include providing input and oversight for preclinical in vivo studies, coordinating with and influencing scientific teams conducting these studies, managing nonclinical Pharmacokinetics studies, analyzing and presenting PK/PD data to project teams and senior management, and preparing summary reports for regulatory submissions

When & where:

• Work Location: Tarrytown, NY

• Work model/flexibility: 4 days per week onsite

Discover your role:

• Serving as a subject matter expert on Preclinical PK/PD within Discovery-stage project teams and guiding the design of preclinical PK/pharmacology studies.

• Collaborating with various internal groups such as Therapeutic Proteins, Therapeutic Function Areas, Assay Development, Precision Medicine, Preclinical Operations, and PPK/PD management to develop and execute PK strategies for projects.

• Effectively communicating project team queries, expectations, and timelines to management.

• Conducting and reporting PK/PD analyses based on data from preclinical studies.

• Working 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.

• Maintaining current knowledge of scientific literature, regulatory guidance, and best practices related to PK/PD.

This role requires:

• PhD in Pharmacology, Pharmacokinetics, Biology/Molecular Biology, or Biochemistry with more than 8 to 10 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, CRISPR-based therapeutics, and cell therapies is highly beneficial.

• Proven ability to plan, coordinate, lead PK and/or PK/PD studies, and analyze related data.

• Familiarity with PK/PD (e.g., WinNonLin), data visualization and AI software and 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.

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

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.

Salary Range (annually)

$176,100.00 - $287,300.00