Job Description

Job Description Summary

East Hanover, New Jersey | Cambridge, Massachusetts

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. You will perform or supervise execution of the pharmacometrics strategy in those programs with focus on implementing model-informed drug development (MIDD) approaches, manage a portfolio of projects at the disease area or indication level, and set the strategy for addressing pharmacometric issues in regulatory submissions and integrated evidence generation that directly influence drug development decisions with internal and external partners.

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 such as 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, and identify alternative strategic options to mitigate risk on clinical programs.
• Lead and contribute to Integrated Evidence generation by leveraging disease progression and PK/PD modeling techniques using varied data sources, including Real World Data.
• Ensure that the Analytics team (biostatistician, data management, database programming, medical and scientific writing) is aligned on the pharmacometrics strategy, execution, and delivery of assigned projects.
• Represent PMX in due-diligence teams to evaluate in?licensing opportunities.

Location & Working Arrangement

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.

Role Requirements

Essential 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 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 and safety analysis.
• Track record of contributions to external whitepapers and 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.

Compensation and Benefits

The salary for this position is expected to range between $152,600 and $283,400 per year. Compensation includes a performance?based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. Eligible employees receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a generous time?off package including vacation, personal days, holidays and other leaves.

Accessibility and Reasonable Accommodations

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please send an e?mail to tas.nacomms@novartis.com or call +1?877?395?2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

EEO Statement

Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Desired Skills

• Algorithms
• Clinical Trials
• Cross?Functional Teams
• Data Engineering
• Decision Making
• Innovation
• Mentorship
• Modeling And Simulation
• Simulation Software
• Waterfall Model

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