Associate Director Pharmacometrics (PhD/PharmD)

Role Summary

Associate Director Pharmacometrics, with a PhD/PharmD, driving the pharmacometric strategy for clinical programs across multiple indications. Lead or supervise pharmacometrics activities, applying model-informed drug development (MIDD) approaches, and influence regulatory submissions and evidence generation with internal and external partners.

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: 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 pharmacometrics expert within the Development Unit; represent PMX at global regulatory hearings and other regulatory interactions
• Drive and coordinate the synthesis and integration of pharmacometrics information to support transition of drug development milestones / decision boards; 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 is aligned on the pharmacometrics strategy, execution, and delivery of assigned projects
• Represent PMX in due-diligence teams to evaluate in-licensing opportunities

Qualifications

• 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 their application in dose-exposure-response analysis, population PK/PD modeling, disease progression modeling, and clinical trial simulation in academia and/or industry
• Required: Clinical pharmacology, statistics and therapeutic knowledge in one or more disease areas
• Required: Diverse experience in pharma industry on incorporation of MIDD strategies into drug development plans across all phases and addressing dose/regimen justification, study design, safety analysis, among others
• Required: Track record of contributions to external whitepapers/policy shaping best practice in pharmacometrics; established track record of developing/pharmacometrics excellence
• Required: Scientific leadership skills demonstrated in facilitating and optimizing the clinical development strategy; track record of global scientific leadership in modern program/trial design methodologies