Associate Director Quantitative Pharmacology

BioSpace; Village of Tarrytown (NY); Hybrid; USD 176,000 - 287,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

401(k) company match

Health and wellness programs

Job summary

Regeneron is seeking an Associate Director in Quantitative Pharmacology to lead model-informed drug development strategies across modalities including antibodies, siRNA, and gene therapies. The role informs dose selection, trial design, and regulatory strategy from early development through submission.

The position offers work-location flexibility with onsite/remote options, and requires strong PMx expertise, extensive modeling tools, and proven regulatory submission experience.

Qualifications

• PhD or MS with substantial industry experience in pharmacometrics and drug development.
• Proven ability to design and oversee PMx analyses for PK/PD and exposure–response.
• Experience supporting regulatory submissions and direct interactions with agencies.

Responsibilities

• Lead model-informed drug development strategies across modalities.
• Communicate complex PMx results clearly to cross-functional teams and stakeholders.
• Design and oversee PMx analysis plans for PK/PD and mechanistic modeling.
• Prepare and deliver study reports and regulatory submission documents.

Skills

Exceptional communication

Cross-functional leadership

Regulatory submission experience

Education

PhD in Quantitative Pharmacology/Pharmacometrics/Engineering

MS with 9+ years of relevant experience

Tools

NONMEM

Monolix

Simulx

MATLAB/SimBiology

R

Job description

Build Our Future Together

We are seeking a highly motivated Associate Director to join the Quantitative Pharmacology (QP) group. The Associate Director will lead model-informed drug development strategies supporting one or more therapeutic areas across modalities including antibodies, siRNA, and gene therapies. This role combines scientific depth with cross-functional leadership to inform dose selection, trial design, and regulatory strategy from early development through submission.

When & Where

• Work Location: Tarrytown, NY, Warren, NJ, Cambridge, MA or Remote, USA


• Work model/flexibility: 4 days per week onsite or remote

Discover Your Role

• Proactively-identify and provide significant Pharmacometrics contribution potentially of a complex nature for research and development programs that address strategically important program needs, and that represent scientific advancements of one or more programs and/or aptly address significant regulatory hurdles.


• Contribute to the overall strategic program development and is able to communicate complex Pharmacometrics strategies and results in an influential manner to the development team.


• Independently design and conduct or otherwise oversee the development of PMx analysis plans and applies standardized or advanced scientific techniques to conduct PK, PD, and/or other types of quantitative analyses.


• Is responsible for the preparation and timely delivery of accurate and well-articulated nonclinical or clinical study reports and regulatory submission documents as appropriate.

This Role Requires

• PhD in Quantitative Pharmacology, Pharmacometrics, Engineering, or a related field with 7+ years of post-doctoral or industry experience; or MS with 9+ years of relevant experience.


• Demonstrated expertise in population PK/PD, exposureresponse, or mechanistic modeling (systems biology, or QSP) using tools such as NONMEM, Monolix, Simulx, MATLAB/Simbiology and R.


• Proven track record of delivering analyses supporting regulatory submissions and engaging directly with agencies (e.g., FDA, EMA, PMDA).


• Hands-on experience with a broad range of quantitative and computational tools and a strong publication record.


• Exceptional communication and interpersonal skills, with the ability to influence and partner effectively across technical and non-technical teams.

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.

• 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

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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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