Associate Director Pharmacometrics (PhD/PharmD)

Role Summary

Associate Director Pharmacometrics (PhD/PharmD) role provides global leadership in pharmacometrics for clinical development programs, focusing on model-informed drug development (MIDD) across multiple indications. Drives strategy for pharmacometrics in regulatory submissions and integrated evidence generation, with potential portfolio management at the disease area level.

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 pharmacometrics expert; represent PMX at global regulatory hearings/advisory committee meetings 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 (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

Qualifications

• 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

Education

• Ph.D. or equivalent in a related field; advanced modeling experience required

Additional Requirements

• Location: Cambridge, MA or East Hanover, NJ (hybrid, ~3 days in office per week or 12 days per month)