Associate Director Pharmacometrics (PhD/PharmD)
Novartis
Full-time
Remote friendly (East Hanover, NJ)
United States
Clinical Research and Development
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Role Summary
Associate Director Pharmacometrics (PhD/PharmD) role in pharmacometrics leadership within clinical development programs, focusing on model-informed drug development and regulatory submission strategies. Location in Cambridge, MA or East Hanover, NJ with hybrid schedule.
Responsibilities
- Provide global strategic pharmacometrics leadership for clinical development programs of medium to high complexity
- Develop, write, and execute pharmacometrics analysis plans, and deliver reports on results
- Lead and drive PMX contributions to integrate technical and scientific knowledge in planning and execution of quantitative development programs with focus on MIDD
- Lead pharmacometric contributions to regulatory/submission strategy and related documents
- Represent Global Project Teams and interact with Health Authorities and external key opinion leaders; represent PMX at regulatory hearings and global interactions
- Coordinate synthesis and integration of pharmacometrics information to support milestones and decision boards; identify alternative options to mitigate risk
- Lead and contribute to Integrated Evidence generation using disease progression and PKPD modeling, including Real World Data
- Ensure Analytics team alignment on pharmacometrics strategy, execution, and delivery
- Represent PMX in due-diligence teams for 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
- Diverse pharma industry experience incorporating MIDD strategies across all phases; ability to justify dose/regimen, study design, safety analyses
- Track record of contributions to external whitepapers/policy shaping best practice in pharmacometrics; established internal/external leadership in pharmacometrics
- Scientific leadership in facilitating and optimizing clinical development strategy; global leadership in modern program/trial design methodologies