Novartis · 3 weeks ago
Associate Director Pharmacometrics (PhD/PharmD)
Cambridge, MA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$153K/yr - $283K/yr
6+ years expNovartis is a leading pharmaceuticals company seeking an Associate Director of Pharmacometrics to drive pharmacometric strategy for clinical programs across multiple indications. The role involves leading strategic pharmacometrics initiatives, managing complex clinical development programs, and ensuring alignment with regulatory submissions.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Provide global strategic pharmacometrics leadership for clinical development programs of medium to high complexity, based on relevant technical and disease area knowledge
Develop, write, and execute pharmacometrics analysis plans, and deliver reports on results
Lead and drive PMX contributions to integrate relevant technical and scientific knowledge in the planning and execution of robust quantitative development programs with focus on MIDD strategies
Lead and optimize the provision of pharmacometric contributions to regulatory/submission strategy and related documents: (e.g. briefing books, summaries of clinical pharmacology/efficacy/safety, and responses to Health Authority questions)
Represent the Global Project Teams internally and externally, including interactions with Health Authorities and external key opinion leaders, as the recognized Novartis pharmacometrics expert within the Development Unit (or equivalent). Represent PMX at global regulatory hearings/advisory committee meetings and other global regulatory interactions
Drive and coordinate the synthesis and integration of pharmacometrics information to support transition of drug development milestones / decision boards. As well as Identify alternative strategic options to mitigate risk on clinical programs
Lead and contribute to Integrated Evidence generation by leveraging disease progression and PKPD modeling techniques using varied data sources, including Real World Data
Ensure that the Analytics team (biometrician, data management, database programming, programming, medical and scientific writing) are aligned on the pharmacometrics strategy, execution, and delivery of assigned projects
Represent PMX in due-diligence teams to evaluate in-licensing opportunities
Qualification
Required
Ph.D. in pharmacology, biology, engineering, mathematics, statistics, or a field with significant modeling-related content (or equivalent) with 6+ years' experience in clinical drug development applying model-based methods using NLME methods and its application in Dose-exposure-response analysis, population PK/PD modeling, disease progression modeling and clinical trial simulation in academia and/or industry
Clinical pharmacology, statistics and therapeutic knowledge in one or more disease areas
Diverse experience in pharma industry on incorporation of MIDD strategies into drug development plans across all phases and answering challenging questions on dose and regimen justification, study design, safety analysis among others
Track record of contributions to external whitepapers/ policy shaping best practice in pharmacometrics. Internally and externally established track record of developing/establishing pharmacometrics excellence
Scientific leadership skills demonstrated in facilitating and optimizing the clinical development strategy. Track record for global scientific leadership in the development and evaluation of modern program/trial design methodologies
Benefits
Health, life and disability benefits
401(k) with company contribution and match
Generous time off package including vacation, personal days, holidays and other leaves
Company
Novartis
Novartis is a pharmaceutical company that researches and develops medicines for serious diseases to improve and extend people's lives.
10001+ employees
H1B Sponsorship
Novartis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (27)
2023 (23)
2022 (27)
2021 (31)
2020 (25)
Funding
Current Stage
Public CompanyTotal Funding
$2.49BKey Investors
Bill & Melinda Gates Foundation
2024-06-19Post Ipo Debt· $2.49B
2018-02-14Grant· $6.5M
2000-05-19IPO
Leadership Team
Daniel Grant
Vice President & Global Program Head
John von Brachel
VP, Head of Content Lab
Recent News
2026-01-22
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