Associate Director Pharmacometrics (PhD/PharmD)
Novartis
Full-time
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
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Role Summary
Associate Director Pharmacometrics (PhD/PharmD) role involving driving pharmacometric strategy for clinical programs, implementing model-informed drug development (MIDD), and guiding regulatory submission strategies. Location options include Cambridge, MA or East Hanover, NJ with hybrid in-office requirements.
Responsibilities
- Provide global strategic pharmacometrics leadership for medium to high complexity clinical development programs
- Develop, write, and execute pharmacometrics analysis plans and deliver reports
- Lead and drive PMX contributions to integrate technical and scientific knowledge in planning and execution of quantitative development programs with MIDD focus
- Lead and optimize pharmacometric contributions to regulatory/submission strategy and related documents
- Represent Global Project Teams and interact with Health Authorities and external experts; participate in regulatory hearings/advisory meetings
- Drive synthesis and integration of pharmacometrics information to support transition of development milestones and identify alternative options to mitigate risk
- Lead and contribute to Integrated Evidence generation using disease progression and PKPD modeling with varied data sources including Real World Data
- Ensure Analytics team alignment on pharmacometrics strategy, execution, and delivery
- Represent PMX in due-diligence teams to evaluate in-licensing opportunities
Qualifications
- Ph.D. in pharmacology, biology, engineering, mathematics, statistics, or related field with 6+ years of clinical drug development experience applying model-based methods (NLME, dose-exposure-response, population PK/PD, disease progression modeling, clinical trial simulation)
- Clinical pharmacology, statistics, and therapeutic knowledge in one or more disease areas
- Experience integrating MIDD strategies across all development phases and addressing dose/regimen, study design, and safety questions
- Track record of contributions to external whitepapers/policy shaping best practices in pharmacometrics and establishing pharmacometrics excellence
- Scientific leadership in facilitating clinical development strategy and modern program/trial design methodologies
Education
- Ph.D. in relevant field required