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Associate Director Pharmacometrics (Phd/Pharmd)

USD 152,600 - 283,400 years
Not Disclosed
10 Nov. 26, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Associate Director, Pharmacometrics (PhD/PharmD)

Location: East Hanover, New Jersey / Cambridge, Massachusetts, USA
Job ID: REQ-10054511
Position Type: Full-Time, Onsite (Hybrid schedule applicable)
Posted: November 03, 2025

Overview

Novartis is seeking an experienced Associate Director of Pharmacometrics to provide strategic leadership and drive model-informed drug development (MIDD) across multiple clinical programs. This role is integral to optimizing clinical development strategies, influencing regulatory submissions, and guiding evidence generation through advanced pharmacometric methodologies.

The position requires onsite presence in either Cambridge, MA or East Hanover, NJ, with a hybrid working structure.

Key Responsibilities

  • Lead global pharmacometrics strategy for clinical development programs of medium to high complexity.

  • Develop, write, and execute pharmacometric analysis plans, including production of technical reports.

  • Drive quantitative development programs using MIDD principles, integrating PK/PD data, disease progression models, and real-world evidence.

  • Provide expert contributions to regulatory and submission strategies, including briefing documents, clinical pharmacology summaries, and responses to regulatory authority queries.

  • Represent Novartis as the pharmacometrics subject matter expert at internal and external meetings, including Health Authority interactions and advisory committee discussions.

  • Guide decision-making for drug development milestones by synthesizing pharmacometric evidence and identifying alternative strategic pathways.

  • Collaborate with cross-functional teams (biometrics, medical writing, clinical pharmacology, data management) to ensure alignment with pharmacometrics strategy.

  • Participate in due-diligence evaluations related to in-licensing opportunities.

Required Experience and Qualifications

  • PhD in pharmacology, biology, engineering, mathematics, statistics, or a discipline with substantial modeling content (or equivalent qualification).

  • Minimum 6 years of experience in clinical drug development applying nonlinear mixed-effects (NLME) modeling, dose-exposure-response analysis, population PK/PD modeling, disease progression modeling, and clinical trial simulations.

  • Strong understanding of clinical pharmacology, biostatistics, and therapeutic area disease biology.

  • Proven experience integrating MIDD strategies into development plans across different phases of clinical trials.

  • Demonstrated record of scientific leadership, including contributions to whitepapers, publications, or policy recommendations in pharmacometrics.

  • Experience representing pharmacometrics teams in global regulatory interactions.

  • Ability to lead scientific discussions, influence strategic decisions, and ensure high-quality delivery of quantitative analyses.

Compensation

  • Salary Range: USD 152,600 to 283,400 annually
    (Based on experience, qualifications, and internal equity. Subject to periodic review.)

  • Performance-based cash incentives

  • Eligibility for annual equity awards

Benefits

US-based eligible employees will receive:

  • Comprehensive health, life, and disability insurance

  • 401(k) with company contribution and match

  • Generous paid time off, personal days, holidays, and additional leave programs

  • Access to Novartis’ professional development and learning resources

For detailed benefits and rewards information, visit the Novartis Life Handbook.

Why Join Novartis

Novartis is committed to reimagining medicine and improving patient outcomes worldwide. The organization values innovation, scientific excellence, and collaboration. This role provides the opportunity to contribute to impactful development programs that shape future therapeutic advancements.

Equal Employment Opportunity

Novartis is an Equal Opportunity Employer and does not discriminate based on race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, marital status, or veteran status.

Accessibility and Accommodations

Candidates requiring reasonable accommodations during the application or hiring process may contact the Novartis accommodations team at the provided support channels.