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About the Role
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.
Responsibilities
- Driving model-informed development (MIDD) and pharmacometrics strategies in partnership with Clinical Pharmacology, Biostatistics, Clinical and Translational teams to support regulatory and clinical decision-making.
- Leading the Quantitative Pharmacology evaluation of one or more assets, accountable for timely delivery of population PK/PD, exposure–response, and translational modeling analyses.
- Representing Quantitative Pharmacology at program and governance meetings, communicating quantitative insights clearly to non-modeling audiences.
- Contributing to regulatory interactions and authoring key components of regulatory documents related to Quantitative Pharmacology (e.g., IB, briefing books, etc.).
- Mentoring and developing junior scientists and fostering a culture of scientific rigor and collaboration.
- Identifying and implementing process improvements, new modeling approaches, and innovative quantitative tools to enhance efficiency and impact.
- Ensuring analyses and documentation are of the highest scientific quality and regulatory compliance.
Requirements
- PhD in Quantitative Pharmacology, Pharmacometrics, Engineering, or a related field with 7+ years of industry experience; or MS with 10+ years of relevant experience.
- Demonstrated expertise in population PK/PD, exposure–response, 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.
Skills
- NONMEM
- Monolix
- Simulx
- MATLAB/Simbiology
- R
Location
- Tarrytown, NY
- Warren, NJ
- Cambridge, MA
- Remote, USA
Work Type
- 4 days per week onsite
- Remote
Experience Level
- 7+ years of industry experience (with PhD)
- 10+ years of relevant experience (with MS)
Education Level
- PhD in Quantitative Pharmacology, Pharmacometrics, Engineering, or a related field
- MS in a related field
Salary/Compensations
- $176,100.00 - $287,300.00
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
About the Company
- We are committed to building a workplace with an inclusive culture.
- Regeneron offers a competitive and comprehensive total rewards package.
- We believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.
Equal Opportunity
- 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.