Associate Director Pharmacometrics (PhD/PharmD)

Novartis•Cambridge, MA

2d•Hybrid

About The Position

About the role: We are 60 quantitative scientists supporting more than 80 clinical development projects in 10 therapeutic areas every day. As the Associate Director Pharmacometrics, you will drive the pharmacometric strategy for clinical programs in multiple indications or a disease area. In this role, you will perform or supervise execution of the pharmacometrics strategy in those programs with focus on implementing model-informed drug development (MIDD) approaches. You may manage a portfolio of projects at the disease area or indication level. You will set the strategy for addressing pharmacometric issues in regulatory submissions and integrated evidence generation directly influencing drug development decisions with internal and external partners. Job Description Your Key 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. Video Link https://www.youtube.com/watch?v=ggbnzRY9z8w The ideal location for this role is the Cambridge, MA or East Hanover, NJ site. This role offers hybrid working, requiring 3 days per week or 12 days per month in the office.

Requirements

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.

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

Benefits

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

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